Archive from December 23th, 2020 – November 17th, 2020
Young Man Develops ‘Rare Life-Threatening Syndrome’ After COVID-19 Vaccine
Twenty-four hours after receiving the COVID-19 vaccine, a 23-year-old man developed a rare multisystem inflammatory syndrome, which causes, among other things, severe damage to heart function.
Prof. Dror Mevorach, director of the coronavirus department at Hadassah, tweeted on the matter, writing, “Rare life-threatening multi-system inflammatory syndrome (MIS) following BNT162b2 mRNA COVID-19 vaccination in a 23 y old social worker was identified at our Department of Medicine B at Hadassah Medical Center, Jerusalem, Israel and reported to MOH and WHO.”
Mevorach told Channel 12: “We found out that the young man had contracted the coronavirus asymptomatically before he was vaccinated. It may be accidental but I would not underestimate it. Care must be taken in vaccination of people who were sick with coronavirus in the past.”
A Nursing Home Had Zero COVID Deaths. Then, It Vaccinates Residents And The Deaths Begin
December 29, when deaths of residents with coronavirus began occurring at The Commons, is also, Mulder’s article discloses, seven days days after the nursing home began giving coronavirus vaccinations to residents, with 80 percent of residents so far having been vaccinated.
Over a period of less than two weeks since December 29, Mulder relates that 24 coronavirus-infected residents at the 300-bed nursing home have died.
The nursing home began vaccinating residents Dec. 22.
So far 193 residents, or 80%, and 113 employees, or less than half the staff, have been vaccinated.
The nursing home plans to do more vaccinations Jan. 12.
Oshkosh Frontline Worker Has Severe Allergic Reaction to COVID Vaccine; Recommends People Get Vaccinated
Bratz said her allergy doctor gave her the greenlight for the shot.
“‘Well, some protection is better than none, especially with working in healthcare and being exposed to people with possible COVID more often,’ so she said go ahead and get it but be prepared if you do react,” Bratz said.
Starting at the age of 21, Bratz became allergic to food high in nickel that includes leafy greens, soy, wheat, and anything in a can.
After receiving the first dose of the Moderna vaccine on Monday, Bratz was taken to the emergency room for monitoring upon getting epinephrine to treat her negative reaction.
No Evidence COVID-19 Vaccines Will Block Spread of Coronavirus
Finally, the World Health Organization (WHO) is also not particularly bullish on the ability of COVID-19 vaccines to control the SARS-CoV-2 contagion. “I don’t believe we have the evidence on any of the vaccines to be confident that it’s going to prevent people from actually getting the infection and therefore being able to pass it on,” said the WHO’s chief scientist, Dr. Soumya Swaminathan.
In short then, what has been measured in the trials on the BNT162b2 and mRNA-1273 vaccines, as well as other experimental COVID-19 vaccines, is not whether they prevent infection with and transmission of the SARS-CoV-2 virus but how well they can prevent or minimize symptoms of COVID-19 disease that can be caused by the virus. There is no evidence to suggest the vaccines will have any effect in terms of protecting people from getting the virus and spreading it.
LAUSD Students Must Get COVID-19 Vaccine Once It Becomes Available for Them, Beutner Says
Once COVID-19 vaccines are available to children, Los Angeles students will have to be immunized before they can return to campus, Supt. Austin Beutner said Monday.
He did not, however, suggest that campuses remain closed until the vaccines are available. Instead, he said, the state should set the standards for reopening schools, explain the reasoning behind the standards, and then require campuses to open when these standards are achieved.
A COVID-19 vaccine requirement would be “no different than students who are vaccinated for measles or mumps,” Beutner said in a pre-recorded briefing. He also compared students, staff and others getting a COVID-19 vaccine to those who “are tested for tuberculosis before they come on campus. That’s the best way we know to keep all on a campus safe.”
COVID-19 Vaccine Roll-out Won’t Achieve Herd Immunity This Year — Health Experts
The roll-out of coronavirus vaccines in many countries will not provide herd immunity from the global pandemic this year, several health experts said on Monday, citing limited access for poor countries, community trust problems and potential virus mutations.
“We won’t get back to normal quickly,” Dale Fisher, chairman of the World Health Organization’s (WHO) Outbreak Alert and Response Network, told the Reuters Next conference.
“We know we need to get to herd immunity and we need that in a majority of countries, so we are not going to see that in 2021,” Fisher said. “There might be some countries that might achieve it but even then that will not create ‘normal’ especially in terms of border controls.”
Trump administration reverses course and adopts part of Biden vaccine distribution plan
The Trump administration plans to release reserved second doses immediately, a senior administration official tells CNN. The official expects reserved doses to be distributed over the next two weeks.
The move comes after Trump administration officials recently disparaged Biden’s plan to do the same.
“If President-elect Biden is calling for the distribution of vaccines knowing that there would not be a second dose available, that decision is without science or data and is contrary to the FDA’s approved label,” Operation Warp Speed spokesman Michael Pratt said Friday in light of Biden’s announcement. “If President-elect Biden is suggesting that the maximum number of doses should be made available, consistent with ensuring that a second dose of vaccine will be there when the patient shows up, then that is already happening.”
Pfizer, BioNTech Boost Vaccine Output Goal by More Than 50%
Pfizer Inc. and BioNTech SE plan to produce 2 billion doses of their COVID-19 vaccine this year, boosting previously expected output by more than 50% in response to surging global demand.
The companies have already agreed to deliver more than 1 billion doses in pacts with various countries, BioNTech said in a presentation at the JP Morgan Healthcare Conference on Monday. The European Union last week sealed a deal to double its supply of Pfizer-BioNTech shots to as many as 600 million, while the U.S. has locked in a total of 200 million doses.
India Delivers COVID-19 Shots to Prepare for ‘World’s Biggest Vaccination Drive’
Vaccinations are set to begin on Saturday in an effort that authorities hope will see 300 million high-risk people inoculated over the next six to eight months.
First to get the vaccine will be 30 million health and other frontline workers, followed by about 270 million older than 50 or deemed high-risk.
Airlines were due to deliver 5.65 million vaccine doses on Tuesday to various cities, Aviation Minister Hardeep Singh Puri said on Twitter.
Controversial Rapid Test Policy Divides Doctors and Scientists
The UK government’s new policy of distributing rapid coronavirus tests to local authorities in England has divided the medical and scientific community, with some calling for the tests to be halted because they could falsely reassure people and increase the spread of COVID-19.
Critics are also concerned that the policy, announced on Sunday 10 January, was being rolled out without sufficient provision for people who test positive, such as putting them in hotels and compensating them financially. Supporters say the tests are a valuable additional tool in public health interventions to identify new cases and suppress further transmission.
Facing a Deluge of Cases, California Turns Baseball Stadiums Into Vaccination Sites
The approach includes transforming Dodger Stadium from one of the nation’s biggest and most visible COVID-19 testing sites into a mass vaccination center. Petco Park, where the San Diego Padres play, and the state fairgrounds in Sacramento are also being set up as vaccination sites, the governor said.
The Orange County board of supervisors said on Monday that the county’s first of five planned “super” vaccination sites .”
Yes, You Can Still Get Infected With COVID-19 After Being Vaccinated. CNN reported:
The CDC estimates that 40% of coronavirus infections don’t cause symptoms, and the trials of both the Moderna and Pfizer/BioNTech vaccines looked only at whether the vaccines prevented symptomatic infections.
Moderna said in December it had submitted data to the U.S. Food and Drug Administration showing its vaccine prevented 2/3 of all infections, including asymptomatic infections. For now, the CDC recommends that people not assume they are completely immune to infection after having been vaccinated.
Overall, both vaccines provided about 95% protection in clinical trials — so a small number of people might still catch the virus even after two shots. In wider use, this efficacy rate may go down as people with varying levels of immune system response get vaccinated and then go out into the world.
Is Your COVID Vaccine Site Prepared for Rare, Life-Threatening Reactions? NBC News reported:
As the rollout of COVID-19 vaccines picks up across the U.S., moving from hospital distribution to pharmacies, pop-up sites and drive-thru clinics, health experts say it’s vital that these expanded venues are prepared to handle rare but potentially life-threatening allergic reactions.
“You want to be able to treat anaphylaxis,” said Dr. Mitchell Grayson, an allergist-immunologist with Nationwide Children’s Hospital in Columbus, Ohio. “I hope they’re in a place where an ambulance can arrive within 5 to 10 minutes.”At least 29 people who have received shots of the two new Covid vaccines authorized for use in the U.S. suffered anaphylaxis, a severe and dangerous reaction that can constrict the airways and send the body into shock, according to the Centers for Disease Control and Prevention.
COVID-19 Vaccination Plan ‘Not Working,’ Former FDA Official Warns. CNN reported:
Experts have long said the best defenses against surging cases are preventative measures like masks and social distancing, as well as widespread vaccination. So far, at least 22.1 million doses of coronavirus vaccines have been distributed and nearly 6.7 million have made their way into patients’ arms. Health officials had hoped to get 20 million people vaccinated at the start of the new year, but the administration of vaccines has undergone delays and roadblocks.
“We need to acknowledge that it’s not working,” Gottlieb said Sunday of the vaccination plan. “We need to hit the reset and adopt a new strategy in trying to get that out to patients.”
COVID-19 Vaccine Rollout at Nursing Homes Encounters Fewer Residents, Reluctant Staff. Wall Street Journal reported:
Hesitancy on the part of long-term-care-facility staffers to receive COVID-19 vaccinations is slowing the rollout of the shots to the nation’s nursing homes and assisted-living centers, CVS Health Corp. said Wednesday.
Another factor driving lower-than-anticipated rollout numbers: Initial estimates by the facilities overstated the number of people living in them by about 20% to 30%, CVS said. During the pandemic, families have been reluctant to send relatives to nursing homes, which have been linked to more than 115,000 deaths.
“Based on feedback from our field teams, we’ve encountered more vaccine hesitancy among staff when compared with residents,” a CVS spokesman said. Facilities are also staggering dosing to staff because of potential side effects, which has extended the process.
Coming to a Black Market Near You: COVID-19 Vaccine. NBC News reported:
The much-criticized rollout by the Trump administration has laid the groundwork for a scenario in which the rich and the politically connected use their money and power to cut in line and get vaccinated before everyone else, they said.
New York Gov. Andrew Cuomo has already threatened to impose fines of up to $1 million and revoke the licenses of doctors, nurses and others who don’t follow state and federal vaccine distribution guidelines, which currently place a priority on inoculating front-line health care workers and nursing home residents.
There have been reports in Miami of big hospital donors getting the first crack at the vaccine and in New York of tycoons flying their friends down to Florida to get inoculated with doses earmarked for a retirement home.
Problems With Paying People to Be Vaccinated Against COVID-19. JAMA reported:
… Third, some might feel that a substantial monetary incentive for vaccination is coercive. While this is a misconception that confuses an offer with a threat, there is a genuine ethical concern about the influence of such an incentive on decision-making.10 Offering payment as an incentive for COVID-19 vaccination may be seen as unfairly taking advantage of those U.S. residents who have lost jobs, experienced food and housing insecurity, or slipped into poverty during the pandemic. COVID-19 has shone a spotlight on the substantial inadequacies of the social safety net in the U.S. As individuals and families struggle, some people might feel they must accept a vaccine in order to, for example, purchase food or pay rent. They might feel they have no choice but to be vaccinated for cash. It is deeply problematic that the government would offer cash incentives to promote vaccination when it has failed, in numerous instances throughout this pandemic, to offer money or other supports needed to ensure that the basic needs of many people are being met. This concern may be particularly pronounced in Black and Brown communities, which have been disproportionately affected by both the health and economic consequences of the pandemic. Although these communities would be expected to benefit from high levels of vaccination, other methods are more appropriate to promote this end than trading on financial insecurity.
Biden to Speed Up COVID-19 Vaccinations. The Hill reported:
President-elect Joe Biden intends to make big changes in the federal COVID-19 vaccine distribution playbook, pledging to release every available dose of COVID-19 vaccines to states upon taking office.
Told to CNN by Biden’s transition team, the decision to release all of the federal government’s vaccine supply will initiate a wave of newly available vaccine doses to states to distribute, potentially increasing inoculations across the country.
The plan hinges on vaccine manufacturers to be able to keep up with demand. It’s placing responsibility on Pfizer and Moderna to keep up with supply levels to ensure people vaccinated with the first dose can receive the second within the recommended time frame of three weeks.
UK Ramps Up Vaccine Rollout, Targets Every Adult by Autumn. ABC News reported:
Britain’s health secretary said Sunday that every adult in the country will be offered a COVID-19 vaccine by the autumn as the U.K. ramps up its mass vaccination program amid a huge surge of infections and hospital admissions.
More than 600,000 people age 80 and over will begin receiving invitations this week to get the coronavirus shot at new large-scale vaccine centers around England. Health Secretary Matt Hancock said that officials were “on track” to reach its target of inoculating about 15 million people in the most vulnerable groups by the middle of February.
‘It Became Sort of Lawless’: Florida Vaccine Rollout Turns Into a Free-for-All. New York Times reported:
States across the country, even as they race to finish vaccinating health care employees, nursing home residents and emergency workers, are under pressure from residents to reach a broader section of the public. Florida, which has already prioritized a large swath of its population to receive the vaccine, illustrates the challenges of expanding a vaccination program being developed at record speed and with limited federal assistance.
“How do you do something this huge and roll it out?” said Dr. Leslie M. Beitsch, the chairman of the behavioral sciences and social medicine department at Florida State University. “It’s not in any way surprising — to anyone who followed it closely, for sure — that there would be halting kind of progress and missteps getting something of this magnitude underway initially, whether we’re talking about Florida or the entire country.”
Oxford-AstraZeneca Vaccine Can Be Up to 80% Effective With a Delay Between Doses – UK official. Reuters reported:
Oxford and AstraZeneca’s COVID-19 vaccine can be 80% effective when there are three months between shots, an official involved in approving the vaccine in Britain said, but there is insufficient evidence to back a regime involving a half dose.
“Effectiveness was high, up to 80%, when there was a three month interval between first and second doses, which is the reason for our recommendation,” Munir Pirmohamed, Chair of the Commission on Human medicines expert Working Group on COVID-19 vaccines, said on Wednesday.
“We also looked at the half dose regimen, which has been publicised quite widely, but we felt that the results were not borne out by the full analysis,” he said at a news conference where the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) presented its decision.
COVID-19: Indian Health Officials Defend Approval of Vaccine. The BMJ reported:
Health officials have defended India’s decision to approve a homegrown COVID-19 vaccine without efficacy data—a move that triggered criticism amid speculation that regulators may have buckled under a government wish for an Indian vaccine alongside those now authorised in other countries.
Researchers have criticised the decision by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO), the regulatory agency, to grant accelerated approvals to the Oxford AstraZeneca vaccine manufactured in India by the Serum Institute of India and the vaccine from India’s Bharat Biotech.
Vaccine Scepticism in France Reflects ‘Dissatisfaction With Political Class’. The Guardian reported:
On Monday France’s government and health authorities are speeding up the country’s COVID-19 vaccine drive — a process complicated by widespread skepticism about the inoculation that has encompassed the usual global conspiracy theories.
For weeks, polls have suggested up to 60% of French citizens do not wish to be vaccinated. As the government’s vaccine operation enters its third week, official figures show that as of Saturday at least 93,000 people had been given the jab – a much lower number than elsewhere in Europe, including the UK, Germany and Italy.
January 7, 2021
Moderna COVID-19 Vaccine Trial Open to Kids and Teens in Houston. KHOU reported:
Just last week, the Houston Fights COVID Movement together with the Cy-Fair Clinical Research Center began vaccinating kids and teens for Moderna.
“Right now we’re in the hundreds and looking to be in the thousands,” said Hasan. “We’re looking for teenagers between 12 and 17 to be part of this initiative.”
‘Perfectly Healthy’ Florida Doctor Dies Weeks After Getting Pfizer COVID Vaccine. CHD reported:
The wife of a Florida doctor who died 15 days after receiving Pfizer’s COVID-19 vaccine told reporters at USA Today and the Daily Mail that her husband was “perfectly healthy” before he got the vaccine.
Heidi Neckelmann said her husband, 56-year-old Dr. Gregory Michael, “sought emergency care three days after the shot because he had dots on his skin that indicated internal bleeding.”
Michael received the vaccine on Dec. 18 at Mount Sinai Medical Center in Miami Beach, where he’d worked for 12 years as an OB-GYN. He died on Jan. 3 after suffering a hemorrhagic stroke related to a lack of platelets, a condition called thrombocytopenia, or as the Daily Mail reported, acute idiopathic thrombocytopenic purpura (ITP).
Chilean Lawmakers Propose Making Coronavirus Vaccine Mandatory. NBC News reported:
Chilean lawmakers on Tuesday presented a bill before Congress that would make vaccination against the coronavirus mandatory as the country’s center-right government pushes to inosculate the majority of its population by mid-year.
The bill would modify the country’s health code, which already requires vaccination against smallpox, whooping cough and other diseases, according to the opposition Christian Democracy party lawmakers who submitted the legislation.
CDC Says Severe Allergic Reactions to the COVID Vaccine Run 10 Times Reactions to the Flu Shot but They’re Still Rare. CNBC reported:
The COVID-19 vaccine appears to cause severe allergic reactions at a significantly higher rate than other vaccines among the first wave of Americans to receive the life-saving immunizations, though the reactions are still rare, the U.S. Centers for Disease Control and Prevention said Wednesday.
The CDC said there were 21 cases of anaphylaxis — a severe and life-threatening allergic reaction that occurs rarely after vaccination — out of the nearly 1.9 million people who received their first shot of Pfizer’s COVID-19 vaccine in mid- to late December, according to a study published in the CDC’s Morbidity and Mortality Weekly Report on Wednesday.
A Second Chinese Coronavirus Vaccine Is Said to Be Effective. New York Times reported:
The vaccine prevented all participants from developing serious and mild complications from the virus, officials said, calling it a highly effective preventive tool.
In anticipation of approval, the vaccine, called CoronaVac, has already been shipped around the world as countries prepare for mass inoculation campaigns. Sinovac has sold more than 300 million doses, mostly to low- and middle-income countries, accounting for about half of the total doses that China says vaccine makers were capable of producing in 2020, based on an analysis of company statements and media reports.
Walgreens, CVS to Finish First Round of COVID-19 Vaccinations by Jan. 25. Fox Business reported:
CVS says states will have “activated nearly 31,000 assisted living facilities partnering with CVS Health by next week, with first doses administered in all facilities within three to four weeks of start dates.”
Both companies also reached an agreement with federal health officials to distribute free vaccines to the general public once they become available. The goal is to make getting a COVID-19 vaccine similar to getting a flu shot.
Walgreens plans to expand access to the general population at over 9,000 stores “once COVID-19 vaccines become available more broadly in 2021,” the company said.
CureVac Strikes COVID-19 Vaccine Alliance With Bayer. Reuters reported:
CureVac has signed up Bayer as a partner for its experimental COVID-19 vaccine, keeping a project that is starting late-stage clinical trials in German hands.
The move underscores Germany’s push for a homegrown vaccine after local rival BioNTech partnered with U.S. drugmaker Pfizer on its COVID-19 inoculation, which is already being rolled out.
“Bayer will contribute its expertise and established infrastructure in areas such as clinical operations, regulatory affairs, pharmacovigilance, medical information, supply chain performance as well as support in selected countries,” the companies said.
Mutant Strains, Experimental Vaccines, Widespread Deaths and Growing Insecurity Aren’t Going Away in the New Year. The Final Call reported:
As the United States braced for a post-holiday wave in the coronavirus pandemic, hospitals reported surges in patient deaths and infections, amid a new, deadlier strain which surfaced in the United Kingdom.
And many frontline workers have been refusing COVID-19 vaccines despite being prioritized along with the elderly in nursing homes and Blacks and Indigenous populations, who suffer disproportionately from underlying health conditions.
A Forbes magazine article catalogued the growing anti-vaccine sentiment: Ohio Gov. Mike DeWine shared his worry when 60% of nursing home workers declined to take the vaccine. More than half the nurses in the critical care unit at Houston’s United Memorial Medical Center told the unit head they would not take the shot. Fifty percent of frontline workers in one California county refused to take the vaccine.
COVID-19 Vaccination: What’s the Evidence for Extending the Dosing Interval? The BMJ reported:
Patients are given a leaflet when attending vaccine appointments, and this has been updated to reflect the latest changes to dosing. It tells patients that it takes one to two weeks for protection to build after the first dose.
It advises, “Like all medicines, no vaccine is completely effective, so you should continue to take recommended precautions to avoid infection. Some people may still get COVID-19 despite having a vaccination, but this should be less severe.”
Scientists Are Monitoring a Coronavirus Mutation That Could Affect the Strength of Vaccines. STAT reported:
As scientists try to track the spread of a new, more infectious coronavirus variant around the world — finding more cases in the United States and elsewhere this week — they are also keeping an eye on a different mutation with potentially greater implications for how well COVID-19 vaccines work.The mutation, identified in a variant first seen in South Africa and separately seen in another variant in Brazil, changes a part of the virus that your immune system’s antibodies get trained to recognize after you’ve been infected or vaccinated. Lab studies show that the change could make people’s antibodies less effective at neutralizing the virus. The mutation seems to help the virus disguise part of its signature appearance, so the pathogen might have an easier time slipping past immune protection.
January 6, 2021
Scientists Criticize ‘Rushed’ Approval of Indian COVID-19 Vaccine Without Efficacy Data. Science reported:
The approval of a vaccine without phase III data is “unconscionable,” says Vineeta Bal, an immunologist at India’s National Institute of Immunology. It also seems to ignore guidelines from the Central Drugs Standard Control Organisation (CDSCO), the authority helmed by Somani, which stipulate that vaccinemakers must show a minimum efficacy of 50% in a phase III trial for their vaccines to be approved, says Gagandeep Kang, a microbiologist at Christian Medical College, Vellore, and a board member of the Coalition for Epidemic Preparedness Innovations. “They provided the guidance and then went against their own guidance,” Kang says. “I don’t know what made them do this.”
The AstraZeneca-Oxford vaccine, produced by the Serum Institute of India (SII) under the name Covishield, is backed by phase III data from studies in Brazil and the United Kingdom. But its approval was rushed as well, says the All India Drug Action Network, a patient rights group. CDSCO guidelines required SII to carry out a “bridging study” showing its vaccine can elicit an immune response comparable with the original AstraZeneca vaccine in the Indian population; a panel of experts advising CDSCO recommended that Covishield’s approval be conditioned on its results. Experts say such a trial is necessary because certain vaccines, such as those against polio and typhoid, have proved less immunogenic in Indians than in Western populations. But the data from SII’s study have yet to be analyzed fully, and the company did not respond to queries from Science.
Fauci: U.S. Could Soon Give 1 Million Vaccinations a Day. AP News reported:
Now, with the holidays over, “once you get rolling and get some momentum, I think we can achieve 1 million a day or even more,” Fauci said. He called President-elect Joe Biden’s goal of 100 million vaccinations in his first 100 days “a very realistic, important, achievable goal.”
It’s an optimistic prediction considering the logistical hurdles facing states and counties as they struggle to administer rationed vaccine supplies amid rising COVID-19 hospitalizations. Fauci pointed to California’s swamped hospitals and exhausted workers even before holiday travel and family gatherings added fuel to the outbreak.
Wealthy Donors Received Vaccines Through Florida Nursing Home. Washington Post reported:
MorseLife has made scarce coronavirus vaccines — provided through a federal program intended for residents and staff of long-term-care facilities — available not just to its residents but to board members and those who made generous donations to the facility, including members of the Palm Beach Country Club, according to multiple people who were offered access, some of whom accepted it. The precise number of invitations, and how many may have also gone to non-donors, could not be learned.
EU Agency Authorizes Moderna’s COVID-19 Vaccine. AP reported:
The European Union’s medicines agency gave the green light Wednesday to Moderna Inc.’s COVID-19 vaccine, a decision that gives the 27-nation bloc a second vaccine to use in the desperate battle to tame the virus rampaging across the continent.
The approval recommendation by the European Medicines Agency’s human medicines committee — which must be rubber-stamped by the EU’s executive commission — comes amid high rates of infections in many EU countries and strong criticism of the slow pace of vaccinations across the region of some 450 million people.
Trump Administration Speeds Up Plan to Deliver COVID Shots in Pharmacies. Politico reported:
The Trump administration late Tuesday said it’s accelerating a plan to begin offering coronavirus shots in pharmacies — a move that comes after federal officials faced fierce criticism for the slow pace of immunizations.
Within the next two weeks, Operation Warp Speed, the federal government’s vaccine accelerator, estimates 3,000 to 6,000 pharmacies could begin administering COVID-19 shots, according to a senior HHS official. The administration announced in November that it would work with major pharmacy chains and independent community pharmacies to distribute vaccines but didn’t lay out a timetable.
You Can Buy an FDA-Approved COVID-19 Test on Amazon. CNN reported:
The DxTerity COVID-19 Saliva at-Home Collection Kit, which received an emergency use authorization last month from the Food and Drug Administration, appears to be the only at-home coronavirus test for sale on Amazon. The kit is currently available in a single pack that costs $110 and in a 10-pack for $1,000.
The kits aren’t new, but DxTerity says its version is the first at-home saliva test to receive this FDA authorization for symptomatic and asymptomatic testing. DxTerity’s kit includes an empty tube for saliva to be sent to a Los Angeles-based lab with prepaid shipping, and the turnaround time for results is between 24 to 72 hours after the sample is received, according to the kit’s description on Amazon.
In many places, on-site COVID-19 tests are available for free or at a low cost. But some consumers may be willing to pay a premium for the convenience of an at-home kit.
FDA Puts Altimmune’s Intranasal COVID-19 Vaccine Trial on Hold. FiercePharma reported:
The FDA has put a planned phase 1 clinical trial of Altimmune’s intranasal COVID-19 vaccine on clinical hold. Altimmune attributed the setback to the need for protocol modifications and additional chemistry, manufacturing and controls (CMC) data.
Maryland-based Altimmune is one of a number of companies working on COVID-19 vaccines that are delivered by means other than injection. Altimmune’s candidate, AdCOVID, is an adenovirus type 5-vectored vaccine that is designed to provide protection against SARS-CoV-2 after administration of a single intranasal dose.
Altimmune’s plans to test the vaccine in humans hit a snag late last year when the FDA issued a clinical hold on the IND filing. The FDA asked Altimmune to make protocol modifications and submit additional CMC data to get the clinical hold lifted.
CVS Projects First Round of Vaccine Doses in Skilled Nursing Homes to Be Completed by Jan. 25. CBS Marketwatch reported:
Shares of CVS Health Corp. CVS, 2.57% were down 1.0% in premarket trading on Wednesday after the drugstore chain said it plans to give the first dose of COVID-19 vaccines in roughly 8,000 skilled-nursing facilities in 49 states by Jan. 25. The program allows both residents and employees of the facilities to get one of the two authorized COVID-19 vaccines right now; both groups are considered by the U.S. government to be at high risk of contracting the coronavirus. “We’re dealing with a vulnerable population that requires onsite and, in some cases, in-room visits at facilities with fewer than 100 residents on average,” CVS CEO Larry Merlo said in a statement. “Despite these challenges we remain on schedule, and the number of vaccines we administer will continue to rise as more facilities are activated by the states.” CVS said it also plans to publish its national and state vaccination figures every day at 4 p.m. ET. Shares of CVS have dropped 4.6% over the last year, while the S&P 500 SPX, 1.09% is up 15.2%.
After a Freezer Filled with COVID-19 Vaccines Broke, a California Hospital Scrambled to Administer More Than 800 Doses in About 2 Hours. CNN reported:
When a freezer that was used to store the Moderna COVID-19 vaccine at a Northern California hospital broke, officials soon realized they only had about two hours to administer the more than 800 doses that were inside
And they took on the challenge.
The executive team at Mendocino County’s Adventist Health Ukiah Valley Medical Center was notified during a safety inspection Monday morning that a freezer was found to be at room temperature, Judson Howe, of Adventist Health, told CNN. And the alarm that was supposed to alert staff of the temperature change had also malfunctioned.
Unlike the Pfizer-BioNTech vaccine, Moderna’s vaccine can be stored in normal freezers and does not require ultra-cold transportation. But at room temperature, the vaccine has a shelf life of about 12 hours, Howe said.
Vaccine Rollouts in Europe Are Off to a Shaky Start, Even as Lockdowns Expand. New York Times reported:
Around the world, inoculation efforts are rolling out slower than promised, even as new cases soar and record numbers of virus patients flood hospitals, placing a double burden on health care providers tasked with leading vaccination drives.
In Europe, where most countries have been under varying degrees of lockdown for months, frustration is building as restrictions have been stepped up or extended while national vaccination efforts are stymied by various problems.
January 5, 2021
Woman In Portugal Dies After Receiving Pfizer Vaccine. EuroWeekly News reported:
A 41-year-old health worker in Portugal suffered a “sudden death” just two days after receiving the Pfizer/BioNTech vaccine. Sonia Acevodo, a mum-of-two had no prior health conditions and hadn’t had any adverse effects after getting the Pfizer jab, according to her distraught family. Sonia worked at the Portuguese Institute of Oncology in Porto before she collapsed on New Year’s Day.
Ms. Acevedo’s father Abilio Acevedo told Portuguese news outlet Correio da Manha: ‘She was okay. She hadn’t had any health problems.
“She had the COVID-19 vaccine but she didn’t have any symptoms. I don’t know what happened. I just want answers.”
Mexican Doctor Hospitalized After Receiving COVID-19 Vaccine. Reuters reported:
The doctor, whose name has not been released, was admitted to the intensive care unit of a public hospital in the northern state of Nuevo Leon after she experienced seizures, difficulty breathing and a skin rash.
Large Numbers of Healthcare and Frontline Workers Are Refusing COVID-19 Vaccine. Forbes reported:
Earlier this week, Ohio Gov. Mike DeWine said he was “troubled” by the relatively low numbers of nursing home workers who have elected to take the vaccine, with DeWine stating that approximately 60% of nursing home staff declined the shot.
Dr. Joseph Varon, chief of critical care at Houston’s United Memorial Medical Center, told NPR in December more than half of the nurses in his unit informed him they would not get the vaccine.
Thousands of Michigan Health Workers Are Turning Down COVID Vaccines. BridgeMichigan reported:
Thousands of health care workers across Michigan who would be first in line for a coronavirus vaccine are declining to take it, potentially slowing efforts to curb a pandemic that has killed over 352,000 nationally and more than 12,600 in Michigan.
In Wayne County, just over half of first responders agreed to take a COVID vaccine, with roughly 600 of 1,600 declining, a county spokesperson told Bridge Michigan on Monday. In Ingham County, nearly a third of those who were eligible to take the vaccine declined, said Linda Vail, the county’s health officer.
Testing Positive for Coronavirus After Getting a Vaccine? Here’s How Likely That is and What to Know if it Happens. USA Today reported:
It’s still possible to test positive for the coronavirus even after getting vaccinated, experts said.
Both the Pfizer-BioNTech and Moderna vaccines require two doses per patient to be fully effective. The first Pfizer-BioNTech dose is more than 50% effective in preventing COVID-19, and the second dose increases that protection to about 95%.
The Centers for Disease Control and Prevention said it can take weeks for a person’s body to build up immunity after getting vaccinated.
“That means it’s possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and get sick,” the agency said. “This is because the vaccine has not had enough time to provide protection.”
Boston Doctor Who Had Allergic Reaction to Moderna Vaccine Describes Experience. NBC Boston reported:
Within moments of receiving the first dose of the vaccine on Thursday, Dr. Hossein Sadrzadeh of Boston Medical Center said his heart began racing. He initially thought it was anxiety, he said, but then felt his tongue and throat tingling and begin to go numb.
“My blood pressure was really down, so this is the time that I knew that this was anaphylactic shock,” Sadrzadeh told NBC10 Boston and NECN. “My heart rate is up, I’m sweating so my blood pressure is really down. I’ve had this before so I had my EpiPen and I administered myself.”
Sadrzadeh, who has a severe shellfish allergy, was taken to the emergency department after receiving the shot that contained the Cambridge-based company’s vaccine. He was feeling normal again by Friday, he said.
Fauci Says He’s ‘Sure’ Coronavirus Vaccinations Will Be Mandatory in Institutions Like Hospitals and Schools. Business Insider reported:
“I’m not sure [the vaccine is] going to be mandatory from a central government standpoint, like federal government mandates,” he said. “But there are going to be individual institutions that I’m sure are going to mandate it.”
Hamilton PSW Says Allergic Reaction to COVID-19 Vaccine Led to Fainting, Seizures and CPR. CBC Radio-Canada reported:
A personal support worker feels the health-care system “failed” her after someone overlooked her allergies, she says, and let her get a COVID-19 vaccine. The vaccine triggered a severe reaction which she says caused her to faint, suffer multiple seizures, require CPR and still feel the effects almost a week later.
Deborah Tilli, 27, is one of the few people to have had a severe reaction to the Pfizer-BioNTech vaccine. And while she doesn’t want people to avoid the vaccine, Tilli says her case is a cautionary tale for those with allergies.
Biden will invoke Defense Production Act to Boost COVID Vaccine Production, Advisor Says. CNBC reported:
“You will see him invoking the Defense Production Act,” Dr. Celine Gounder, a member of Biden’s COVID-19 advisory board, said during an interview on CNBC’s “Squawk Box.” “The idea there is to make sure the personal protective equipment, the test capacity and the raw materials for the vaccines are produced in adequate supply.”
Inside the Fight to Include HIV-Positive People in COVID-19 Vaccine Trials. NBC News reported:
The CDC’s website says people with HIV “may receive the vaccine” but notes that the safety data specific to this population “is not yet available.” The agency adds that people with weakened immune systems “should also be aware of the potential for reduced immune responses to the vaccine, as well as the need to continue following all current guidance to protect themselves against COVID-19.”
FDA Warns Health Officials Not to Mess With COVID-19 Vaccine Doses Schedule. NPR reported:
The U.S. Food and Drug Administration is warning health care workers that any changes to the authorized dosing schedules of COVID-19 vaccines currently being administered will significantly place public health at risk and undermine “the historic vaccination effort to protect the population” from the coronavirus pandemic.
The first and second doses of the Pfizer-BioNTech vaccine are approved to be delivered within a 21-day window, while the Moderna injections should be spread over 28 days. When given at those intervals, both vaccines are about 95% effective, according to the respective drugmakers.
Feds May Cut Moderna Vaccine Doses in Half so More People Get Shots, Warp Speed Adviser Says. Politico reported:
The federal government is in talks with Moderna about giving half the recommended dose of the company’s COVID-19 shot to speed up immunization efforts, the head of the Trump administration’s vaccine rollout said on Sunday.
Operation Warp Speed chief adviser Moncef Slaoui said there is evidence that two half doses in people between the ages of 18 and 55 gives “identical immune response” to the recommended one hundred micorogram dose, but said the final decision will rest with the FDA.
As Rollout Falters, Scientists Debate New Vaccination Tactics. New York Times reported:
As governments around the world rush to vaccinate their citizens against the surging coronavirus, scientists are locked in a heated debate over a surprising question: Is it wisest to hold back the second doses everyone will need, or to give as many people as possible an inoculation now — and push back the second doses until later?
Since even the first shot appears to provide some protection against COVID-19, some experts believe that the shortest route to containing the virus is to disseminate the initial injections as widely as possible now.
Order to Reschedule and Delay Second Vaccine Dose Is ‘ Totally ‘Unfair, Says BMA. BMJ reported:
Healthcare workers in England have been told to reschedule appointments for the second dose of the Pfizer and BioNTech COVID-19 vaccine after the government’s advisory committee decided that vaccinating as many people as possible with a first dose should be the priority.
The BMA has called the decision “unreasonable and totally unfair” and said it could cause “huge logistical problems” for general practices and vaccination centres.
The government has now said that people should receive their second dose of vaccine (whether the Oxford and AstraZeneca or the Pfizer BioNTech one) within 12 weeks of the first, rather than within a few weeks. But many GPs and clinical leaders have told the BMA that delaying already promised second doses “will have a terrible impact on the emotional wellbeing of their most vulnerable, at-risk patients.”
India Approves Oxford-AstraZeneca COVID-19 Vaccine and 1 Other. New York Times reported:
India said on Sunday that it had approved two coronavirus vaccines, one made by AstraZeneca and Oxford University and the other developed in India, for emergency use, a major step toward halting the spread of the coronavirus in one of the world’s hardest-hit countries.
The approvals were announced at a news conference in New Delhi on Sunday. Dr. V.G. Somani, the drugs controller general of India, said the decision to approve the Oxford-AstraZeneca vaccine and a local vaccine developed by Bharat Biotech came after “careful examination” of both by the Central Drugs Standard Control Organization, India’s pharmaceutical regulator.
Oxford-AstraZeneca Vaccine Approved for Use in UK. BBC reported:
The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday.
There will be 530,000 doses available from next week, and vaccination centres will now start inviting patients to come and get the jab.
Priority groups for immunisation have already been identified, starting with care home residents, the over-80s, and health and care workers.
Johnson & Johnson’s Single-Dose Vaccine Next to Seek Emergency Use Authorization. KHOU reported:
Johnson & Johnson’s adenovirus-based vaccine works differently than Pfizer and Moderna’s vaccines, which use messenger RNA. Doctors say it produces an antigen, or protein, which causes an immune response to protect against the novel coronavirus. The same technology was used to develop the Ebola vaccine.
Why Did Johnson & Johnson Cut the Size of Its Coronavirus Vaccine Trial? The Motley Fool reported:
Cardina: Definitely. One thing investors should know is that Johnson & Johnson has pledged not to profit on this vaccine during the pandemic. How does that factor into any sort of investment decision into Johnson & Johnson?
Orelli: It goes back to that same immunity question. We just don’t know how long the vaccine is going to last. If it’s a one and done, there’s enough herd immunity that the virus goes away, then obviously they’re not going to benefit at all. If it requires that we get a booster every year, four years, five years, to 10 years, then it will obviously benefit a little bit. Johnson & Johnson is huge, well diversified. I wouldn’t invest for the coronavirus, but it doesn’t mean you shouldn’t invest in Johnson & Johnson if you’re looking for a solid diversified healthcare investment with a solid dividend that just keeps going up.
BMJ Urges NYT to Correct Vaccine ‘Mixing’ Article. BBC reported:
The editor of the British Medical Journal has asked the New York Times to correct an article that says UK guidelines allow two COVID-19 vaccines to be mixed.
The U.S. publication reported that UK health officials would allow patients to be given a second dose that is a different vaccine to their first.
Fiona Godlee pointed out in her letter to the NYT that it was not a recommendation. She said the NYT’s headline claiming UK guidelines say such substitutions “may happen” was “seriously misleading.”
NYC Healthcare Worker Has City’s First Allergic Reaction to COVID-19 Vaccine. New York Post reported:
A New York City health care worker suffered a “significant allergic reaction” to a COVID-19 vaccine — the first ‘serious adverse event’ to the jab in the Big Apple — and is in stable condition, officials said Wednesday.
“With more than 30,000 COVID-19 vaccinations administered in New York City, we have received a single report of a serious adverse event in a health care worker,” according to the city Health Department.
India Likely to Approve AstraZeneca Vaccine by Next Week. Al Jazeera reported:
The AstraZeneca-Oxford shot is considered vital for lower-income countries and people living in warmer climates because it is cheaper, easier to transport and can be stored for long periods at normal fridge temperatures.
India’s Central Drugs Standard Control Organization (CDSCO) first reviewed the three applications on Dec. 9 and sought more information from all the companies, including from Serum Institute of India (SII), which is making the AstraZeneca shots.
NIH Seeking Individuals for Study on Severe Allergic Reactions to Pfizer vaccine. The Hill reported:
Daniel Rotrosen, director of the Division of Allergy, Immunology and Transplantation at the National Institute of Allergy and Infectious Diseases, told The Washington Post that researchers need people who have a history of severe anaphylaxis.
“This is not a simple study design,” Rotrosen said. “We expect to be looking at highly allergic individuals. They will not necessarily be so easy to recruit, either. A lot still needs to be done to be sure we have the optimal study design. That said, we’re trying to move as quickly as we can, for obvious reasons.”
Beware the Danger of ‘Vaccine Euphoria.’ STAT reported:
The advent of COVID-19 vaccines is a medical miracle, yet also a tantalizing and dangerous psychological milestone: It’s not the beginning of the end of the pandemic but, more likely, “the end of the beginning,” to borrow a phrase from Winston Churchill.
The first day of distribution of vaccine in the United States illustrated the point. California accepted its initial delivery of 33,150 doses, just as it was beginning to average more than that number of new coronavirus cases every day.
Pfizer, Feds Ink Another COVID-19 Vaccine Supply Deal for 100M Doses. FiercePharma reported:
After an initial coronavirus vaccine supply deal inked this summer and a tense back-and-forth last week between the federal government and Pfizer, the two sides have forged another supply agreement. Pfizer and its vaccine partner BioNTech will provide another 100 million doses of their coronavirus shot in the second quarter of 2021, further expanding the available vaccine supply in the U.S.
As it did in its first agreement with Pfizer, the U.S. government agreed to pay $1.95 billion for 100 million doses of the vaccine—or $19.50 per dose. Wednesday’s deal comes after concerns that partners Pfizer and BioNTech wouldn’t have doses to supply the U.S. in the second quarter and after the sides seemed to be negotiating in the media over a potential supply shortfall.
Makers of Successful COVID-19 Vaccines Wrestle With Options for Placebo Recipients. Science reported:
Now that regulators around the world have begun to issue emergency use authorizations for COVID-19 vaccines — the U.S. authorized a candidate vaccine from the biotech Moderna on Friday — a theoretical debate that has simmered for months has become a pressing reality: Should ongoing vaccine efficacy studies inform their tens of thousands of volunteers whether they were injected with a placebo or the vaccine, and also offer an already authorized vaccine to those who got the placebo?
Desantis Breaks With CDC, Says Florida Seniors Next in Line to Receive COVID-19 Vaccine. News4Jax reported:
Gov. Ron DeSantis said Tuesday the next phase of COVID-19 vaccinations in Florida will include senior citizens around the state.
“In Florida, we’ve got to put our parents and grandparents first and that’s what we’re going to be doing,” DeSantis said. “And we’re going to work like hell to be able to get all the vaccines out to elderly who want it.”
“We are not going to put young, healthy workers ahead of our elderly vulnerable population,” he continued.
Vaccine Hesitancy Stirs in Nearly COVID-Free Singapore. Al Jazeera reported:
Singapore is preparing to roll out COVID-19 vaccinations, but the city state’s striking success in controlling the virus is making some question whether they should take the jabs.
In a country where compliance with the authorities is generally high, some Singaporeans fear the potential side effects — even if minimal — are not worth the risk when daily cases are almost zero and fatalities are among the world’s lowest.
Why Americans Will Be Demanding Proof of Vaccination. Axios reported:
You’ve received a coronavirus vaccination — but can you prove it? The answer to that question will help determine how the global economy functions for the next few years.
Why it matters: The federal government will probably neither mandate nor encourage digital immunity passports or other proofs of vaccination. But privately-operated digital certificates are already being developed — and U.S. law means that anybody who gets vaccinated here should be able to obtain the proof they need.
The big picture: Your employer has a clear interest in knowing whether you’ve been vaccinated, as do the immigration staff in any foreign country you want to visit. Many workers, from nursing-home aides to opera singers, have a clear desire and even need to be vaccinated before doing their jobs. Which means they’ll need some kind of proof of vaccination.
December 22, 2020
Vatican: OK to Get Virus Vaccines Using Abortion Cell Lines. ABC News reported:
“The Vatican didn’t name any of the COVID-19 vaccines already being given to people in some countries or authorized to be used soon.
“In its statement, the Vatican explained that obtaining vaccines that do not pose an ethical dilemma is not always possible. It cited circumstances in countries “where vaccines without ethical problems are not made available to physicians and patients” or where special storage or transport conditions make their distribution more difficult.”
Bill Gates-Led Effort to Get $3.36 Billion Into the Coronavirus Deal to Help Vaccinate World’s Poor. Yahoo!News reported:
“As part of the announcement Sunday evening of a $900 billion coronavirus relief deal, House Speaker Nancy Pelosi and Senate Minority Leader Chuck Schumer touted ‘an additional $3.36 billion for a total of $4 billion for GAVI, the international vaccine alliance.’
“The Democratic leaders said the money recognizes that ‘we are not truly safe until the whole world is safe from the coronavirus.’
“Gavi, a public-private health partnership, and a similar organization called the Global Fund have ‘spent two decades becoming experts in the task of financing vaccines, drugs, and diagnostics,’ Gates recently wrote.”
Fauci Tells Kids Not to Worry, He Gave Santa Claus the COVID-19 vaccine. NBC News reported:
“Fauci assured good children that he wouldn’t let them be disappointed after making the nice list in a very tough year. The coronavirus expert anticipated Santa’s essential worker status and took matters into his own hands.
“‘I took a trip up there to the North Pole,’ Fauci said. ‘I went there and I vaccinated Santa Claus myself. I measured his level of immunity, and he is good to go. … Santa Claus is good to go.’”
Suspicions Grow That Nanoparticles in Pfizer’s COVID-19 Vaccine Trigger Rare Allergic Reactions. Science reported:
“Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).
“PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis — a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine.”
Pfizer and Moderna Are Testing Their Vaccines Against UK Coronavirus Variant. CNN reported:
“‘The variant has not been identified in the United States, the U.S. Centers for Disease Control and Prevention said in a Tuesday brief, but “’given the small fraction of U.S. infections that have been sequenced, the variant could already be in the United States without having been detected.’”
Growing Number of Lawmakers Decline Early Access to COVID-19 Vaccine. The Hill reported:
A handful of lawmakers in both parties, including Reps. Brian Mast (R-Fla.), Ilhan Omar (D-Minn.), Tulsi Gabbard (D-Hawaii), Jefferson Van Drew (R-N.J.), Sen. Rand Paul (R-Ky.) and incoming Rep.-elect Nancy Mace (R-S.C.), all made a point of announcing they would refuse a vaccine before all front-line health care workers and seniors get inoculated.
“Most other lawmakers are getting their first of two doses of the vaccine and urging others to follow suit, arguing it’s necessary to ensure continuity of government in the pandemic.”
Biden Receives First Dose of COVID-19 Vaccine on Live Television. CNN reported:
“Biden said the Trump administration deserved some credit for Operation Warp Speed, the federal government’s vaccine program, and their role in making coronavirus vaccinations possible.
“’I also think that it’s worth saying that this is, is great hope. I’m doing this to demonstrate that people should be prepared, when it’s available, to take the vaccine. There’s nothing to worry about. I’m looking forward to the second shot; so is Jill,’ Biden said.”
Confusion Reigns as Companies, Industries Try to Navigate U.S. COVID-19 Vaccine Rollout. Reuters reported:
“The lack of coordinated plans has led dozens of industry groups and individual companies, including Amazon.com Inc and Uber Technologies Inc, to lobby state and federal officials to move their workers closer to the front of the line.
“Several states including New York, Massachusetts and Michigan do not follow the panel’s recommendations and have instead drafted their own list of essential workers to be prioritized for a vaccine. Some also prioritize people with pre-existing medical conditions, who were not accounted for by the advisory panel.”
December 21, 2020
When the Elderly and Frail Die after Receiving the COVID Vaccine. Global Research reported:
“’Since they [the COVID vaccines] haven’t been studied in people in those [elderly] populations, we don’t know how well the vaccine will work for them. We know that most vaccines don’t work nearly as well in a frail elderly person as they would in someone who is fit and vigorous, even if they happen to be the same age,’ Moore said.’
“Again — zero evidence the COVID vaccines work in elderly and frail populations. Most vaccines don’t ‘work nearly as well.’
“CNN: ‘When shots begin to go into arms of [nursing home and long-term care facility] residents, Moore said Americans need to understand that deaths may occur that won’t necessarily have anything to do with the vaccine.’”
FDA Investigates Allergic Reactions to Pfizer COVID Vaccine After More Healthcare Workers Hospitalized. Children’s Health Defense reported:
“The announcement followed Friday’s news that an Illinois hospital temporarily shut down its COVID vaccination program after four healthcare workers there experienced allergic reactions — one of which was severe — to the vaccine.
“Also on Friday, CNN reported that a third healthcare worker in Alaska was hospitalized for six hours for an anaphylactic reaction to the Pfizer vaccine. The report came on the heels of last week’s news that two Alaskan healthcare workers had severe allergic reactions — including one woman who was hospitalized for at least two nights after going into anaphylactic shock.”
Employers Can Require Workers to Get Covid-19 Vaccine, U.S. Says. New York Times reported:
“Employers can require workers to get a COVID-19 vaccine and bar them from the workplace if they refuse, the federal government said in guidelines issued this week.
“Public health experts see employers as playing an important role in vaccinating enough people to reach herd immunity and get a handle on a pandemic that has killed more than 300,000 Americans.”
EU Regulators Recommend Pfizer/BioNTech’s Covid-19 Vaccine for Authorization. CNN reported:
“The European Union drugs regulator has recommended authorizing the Pfizer/BioNTech COVID-19 vaccine for use, paving the way for the first phase of the bloc’s mass vaccination program to begin later this week.
“In a closed-door meeting in Amsterdam on Monday, the European Medicines Agency (EMA) granted the Pfizer/BioNTech vaccine a conditional marketing authorization, green lighting the drug for distribution.
“Before the 27-nation bloc can begin its rollout, the European Commission must give its final approval, which European Commission President Ursula von der Leyen would likely happen later on Monday.”
Police, Firefighters, Teachers Will Be Next in Line for COVID-19 Vaccine. USA Today reported:
“Police, firefighters, teachers and grocery workers will be among those next in line for a COVID-19 vaccine, a Centers for Disease Control and Prevention advisory panel decided Sunday.
“The committee voted 13-1 to recommend that Phase 1b include people 75 and older and front-line essential workers. Phase 1c will include people 65 to 74 and people 16 to 64 who have high-risk medical conditions, along with other essential workers.”
Nursing Homes Face Daunting Task of Getting Consent Before They Give Coronavirus Vaccines. Washington Post reported:
“More than 3 million elderly and infirm residents of nursing homes and other long-term-care facilities may face delays in getting coronavirus vaccines as the facilities confront the difficult task of obtaining consent, which consumer advocates, operators and some health officials say should have been simplified and started earlier by the federal government.
“Obtaining consent presents one of the toughest hurdles as officials mobilize to inoculate residents of these facilities, many of whom have dementia or Alzheimer’s disease.”
Locals Hesitant About COVID-19 Vaccine as CDC Releases Next Group Recommendation. NBC News reported:
“’We’ve been trying to find a cure for cancer and all the other diseases out there so it’s just kind of bothersome to know that they were so quick to find a vaccine for COVID but nothing else so I’m just going to wait,’ said Gina Jimez from Perrysburg who said she will not get the vaccine any time soon.
“’I mean they came out with a drug in six months, it just hasn’t been tested that long enough to see what’s going to be the real results of it, we don’t know the long-term effects on it, we don’t know what’s going to happen the ups and downs and how people are going to react to it,’ said Nick Sarno from Perrysburg who said he will not get the vaccine.”
Russian Scientist Working on COVID-19 Vaccine Plummets to Death in St. Petersburg. New York Post reported:
“Kagansky, best known for his work on cancer research, was an assistant professor in Vladivostok and had spent 13 years working in Edinburgh, Scotland, until 2017, the outlet said.
“He was most recently working as director of the Center for Genomic and Regenerative Medicine at Russia’s Far Eastern Federal University. He had been working on developing a vaccine against the coronavirus, e2news said.”
‘I failed’: Operation Warp Speed Leader Takes Responsibility for COVID-19 vaccine distribution confusion. STAT reported:
“The striking mea culpa — rare among U.S. officials in the response to the COVID-19 pandemic — came during a briefing in which Perna, the chief operating officer of OWS, said repeatedly that he had underestimated the time required to get the vaccine doses approved for distribution to states. The chaos over allotments followed labeling confusion that caused hospital pharmacists at several health systems to throw away one in every six doses of the first vaccines distributed.”
Chinese and Russian Vaccines Remain Unproven — But Desperate Countries Plan to Use Them Anyway. Washington Post reported:
“Cambodian Prime Minister Hun Sen said Tuesday that his country is not ordering a vaccine candidate developed by the Chinese biotech firm Sinovac because it has not been certified by a global body. “Cambodia is not a dustbin . . . and is not a place for a vaccine trial,” he said.
“But the questions over China’s and Russia’s candidates have not stopped other countries from moving forward with deals, approvals and vaccinations”
December 18, 2020
FDA Panel Endorses Moderna’s Covid-19 Vaccine. New York Times reported:
“Moderna would be the second company allowed to begin inoculating the public, giving millions more Americans access to desperately needed vaccine. The first, made by Pfizer and its German partner BioNTech, received authorization last week.
“The Moderna vaccine can be distributed more widely because it can be stored at normal freezer temperatures and, unlike the Pfizer-BioNTech vaccine, does not require ultracold storage. It also comes in much smaller batches, making it easier for hospitals in less populated areas to use quickly.”
Pregnant Women Should Be Offered COVID-19 Vaccine, Experts Agree. Medscape reported:
“COVID-19 vaccines should not be withheld from people who are pregnant or lactating and want to be vaccinated, despite a lack of safety data in these populations, according to guidance from the Centers for Disease Control and Prevention (CDC), the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine.
“Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.
“’Pregnant women who experience fever following vaccination should be counseled to take acetaminophen,’ the advisory notes.”
The Wealthy Scramble for COVID-19 Vaccines: ‘If I donate $25,000 … Would That Help Me?’ The LA Times reported:
“‘We get hundreds of calls every single day,’ said Dr. Ehsan Ali, who runs Beverly Hills Concierge Doctor. His clients, who include Ariana Grande and Justin Bieber, pay between $2,000 and $10,000 a year for personalized care. ‘This is the first time where I have not been able to get something for my patients.’
“With the first doses in short supply, California has laid out a strict order of vaccinations based on need and risk: Healthcare workers and nursing home residents, then essential workers and those with chronic health conditions, then, finally, everyone else.”
States Report Confusion as Government Reduces Vaccine Shipments, While Pfizer Says It Has ‘Millions’ of Unclaimed Doses. Washington Post reported:
“The clashing accounts came as Pfizer and the Trump administration negotiate over additional vaccine doses for the United States. Pfizer, which has already committed to providing the government 100 million doses, said that as recently as October, federal officials had turned down its entreaties to lock in another 100 million doses. When those officials sought to buy those doses later, the company said its supplies were already committed to other countries. Now the pharmaceutical giant and the administration are nearing an agreement that would provide the United States with more than 50 million doses, but fewer than 100 million, probably spread over the second and third quarters of 2021, according to people knowledgeable about the negotiations who spoke on the condition of anonymity.”
Europe Is Paying Less Than U.S. for Many Coronavirus Vaccines. Washington Post reported:
“Comparing that list to calculations by Bernstein Research, an analysis and investment firm, it appears the 27-nation union has a 24 percent discount on the Pfizer vaccine compared to the United States, paying $14.76 per dose compared to $19.50 in the United States. Some of the difference may reflect that the E.U. subsidized that vaccine’s development.
“The bloc will pay 45 percent less than the United States for the AstraZeneca-Oxford vaccine currently under development. But it will pay 20 percent more than the United States for the Moderna vaccine, which is expected to be approved for U.S. use on Friday.”
COVID-19 Vaccine Starts Rolling Out to Members of Congress. ABC News reported:
“The legislative branch of government is rapidly moving to receive the coronavirus vaccine, with top leaders of the U.S. House and Senate getting the shots this week and the top Capitol doctor urging all members of Congress to join them.
“The Capitol physician, Dr. Brian P. Monahan, informed members that they are all eligible for the shots under government continuity guidelines. He asked all members to make appointments with his office to be vaccinated.”
Is COVID-19 Really Improving Pharma’s Reputation? Takeda Survey Says Not so Much. FiercePharma reported:
“Only 17% of adults surveyed in October agreed that their perception of the pharma industry has improved during the pandemic, while the majority (54%) said their opinion hasn’t changed. Ipsos MORI fielded the study with adults in the U.K. and also with healthcare professionals.”
Do we need a COVID-19 vaccine for pets? Science reported:
“SARS-CoV-2 has never been an exclusively human problem. Since the early days of the pandemic, scientists have been concerned about the impact of the virus responsible for COVID-19 on pets, livestock, and wildlife. Cats and dogs can become infected, and cats appear to transmit the coronavirus to other cats, at least in the lab. Minks at hundreds of farms around the globe have suffered outbreaks, leading to massive culling, and in some cases, human infections. And scientists worry people or domestic animals could transmit the virus to wildlife, creating an uncontrollable reservoir of the disease.”
December 17, 2020
You Can’t Sue Pfizer or Moderna if You Have Severe COVID Vaccine Side Effects. The Government Likely Won’t Compensate You for Damages Either. CNBC reported:
“‘It is very rare for a blanket immunity law to be passed,’ said Rogge Dunn, a Dallas labor and employment attorney. ‘Pharmaceutical companies typically aren’t offered much liability protection under the law.’
“You also can’t sue the Food and Drug Administration for authorizing a vaccine for emergency use, nor can you hold your employer accountable if they mandate inoculation as a condition of employment.”
2 Alaska Healthcare Workers Suffer Allergic Reaction to Pfizer COVID Vaccine. How Many More Are at Risk? CHD reported:
“Two days after the first COVID-19 vaccine was administered in the U.S. — to a healthcare worker in Long Island, New York — two healthcare workers in Alaska who received Pfizer’s COVID vaccine experienced allergic reactions. One of those, a woman with no prior history of allergies, suffered an anaphylactic reaction and spent at least two nights in the hospital.”
Pfizer Facing ‘Various Challenges’ in COVID-19 Vaccine Manufacturing, Dosing: Feds. Fierce Pharma reported:
“Why did healthcare workers in California and Alabama have to return trays of Pfizer’s COVID-19 vaccine after discovering they were stored at temperatures that were colder than recommended? Does each vial of the vaccine contain more than the expected five doses, and if so, can those be used to meet the high demand for the shot?
“Those were some of the questions U.S. government officials addressed yesterday. Operation Warp Speed co-leader Gen. Gustave Perna kicked off a press conference citing “an excellent collaboration” between the government and Pfizer, but when asked for additional details, he and other leaders of Operation Warp Speed hinted that the effort to speed the vaccine to vulnerable populations may not be going as smoothly as advertised.”
Major CEOs Signal COVID Vaccine Mandates Could Be on the Way. CNN reported:
“Some business leaders are in favor of requiring their employees take COVID-19 vaccines.
“Seventy-two percent of current and recent CEOs of major companies signaled an openness to vaccine mandates, according to a poll held Tuesday at a virtual summit by the Yale Chief Executive Leadership Institute.”
Pharmacies Will Help Roll Out the Coronavirus Vaccine but one Doctor Warns of ‘Chaos’ CBS News reported:
“After striking deals with the federal government, pharmacies like CVS and Walgreens will help administer the coronavirus vaccine — first to health care workers, long-term care residents and staff and eventually to the general public. Walmart and Sam’s Club are also preparing their pharmacies for the rollout.
“The first doses left Pfizer’s Michigan plant Sunday.
“There are discrepancies, however, about when the first dose will be given to nursing home residents, who are some of the most vulnerable to the virus.”
Did the FDA Understaff Its Review of the Pfizer/Biontech Vaccine? Stat News reported:
“In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do.
“The FDA’s authorization last week followed similar authorizations in the United Kingdom and Canada. But the FDA’s decision is particularly important because of its reputation for being the international “gold standard” in regulatory rigor.”
At Houston Hospital, Head of COVID-19 Unit Sees Some Staff Wary of a Vaccine. NPR reported:
“Varon said that starting next week doctors and nurses at the hospital will begin receiving doses of the recently authorized Pfizer vaccine. Hospital staff, he said, were ‘very happy’ learning this news.
“Still, despite clinical trials showing the vaccine to be 95% effective, Varon said that some of the nurses on his unit tell him they’re not planning on getting vaccinated.”
Moderna Stock Dives As Fauci Questions Durability of COVID Vaccines. Investor’s Business Daily reported:
“Fauci heads up the National Institute of Allergic and Infectious Diseases, which was involved in the testing of Moderna‘s (MRNA) vaccine. Fauci’s commentary came the same day the Food and Drug Administration said data from Moderna’s clinical test of its COVID-19 vaccine ‘met the pre-specified success criteria.’”
Rite Aid Partners With CDC on COVID-19 Vaccine as Profits Soar. Fox Business reported:
“’We have administered over one million COVID-19 tests and will be partnering with the CDC to help administer COVID-19 vaccines in our communities,’ Rite Aid CEO Heyward Donigan said in a statement alongside the company’s quarterly results.”
December 16, 2020
Why Might Women Be Less Eager to Get the Coronavirus Vaccine? An Investigation. Washington Post reported:
“It was also possible that some women were following medical guidance, not from online anti-vaxxers but actual medical caregivers. Pregnant and lactating women were excluded from Pfizer and Moderna’s coronavirus vaccine trials, as they are from many clinical trials (a few dozen participants inadvertently became pregnant during the course of the studies). This means the existing safety assurances might not feel as reassuring to the subset of women who fear not only for their own health but also for their babies.’”
COVID Is Having a Devastating Impact on Children — and the Vaccine Won’t Fix Everything. NBC News reported:
“It has been almost 10 months since COVID-19 began battering families in the United States, putting parents out of work, shrouding their homes in grief and loss, and shutting children out of the schools that taught and cared for them.
“It’s all taken an unthinkable toll on children — a social, emotional and academic ordeal so extreme that some advocates and experts warn its repercussions could rival those of a hurricane or other disaster.”
COVID-19 Vaccine Trial Volunteers Note Occasional Harsh Side Effects. Wall Street Journal reported:
“‘I woke up around midnight freezing,’ said the 68-year-old retired nurse. ‘For the next 24 hours I had intense chills, serious neck pain, headache, all my joints were aching.’ She had a fever that peaked at 102.4 and poured out so much sweat that she lost 3 pounds, she said. The following day she woke up and felt fine.
“Ms. Edwards, like the other 30,000 volunteers who took part in Phase 3 clinical trials for Moderna’s COVID-19 vaccine, wasn’t told whether she got the vaccine or a placebo. However, she said a trial researcher attributed her symptoms to her body mounting a strong immune response to what was most likely the vaccine. ‘It’s better having 36 hours of feeling really rough than getting COVID,’ she said.”
FDA Authorizes First Fully At-Home Test as More COVID-19 Patients Are Hospitalized than Ever Before. CNN reported:
“The US Food and Drug Administration gave emergency authorization Tuesday for the first COVID-19 test that can be fully taken at home.
Other at-home tests require a prescription or require people to send test samples to a lab to get results. But the COVID-19 home test developed by Australian company Ellume is sold over-the-counter and produces results that can be read at home.”
COVID-19 Nasal Spray From Eureka Therapeutics Protects Mice Against Infection. Fierce Pharma reported:
“A single administration of Eureka’s drug into the nose protected mice against SARS-CoV-2 pseudovirus for at least 10 hours, even at the lowest concentrations tested, researchers from the company described in a paper on the preprint site bioRxiv.
“The Bay Area biotech figures the nasal spray, now called InvisiMask, could work as a daily preventive measure against COVID-19, and it’s preparing a clinical trial application with the FDA.”
WHO Sees ‘Strong Commitment’ From Pfizer on Affordable COVID Vaccine. Reuters reported:
“A World Health Organization senior official said on Tuesday that the agency was in talks with Pfizer to include its COVID-19 vaccine as part of an early global roll out.
“Bruce Aylward, WHO senior adviser, said that he saw a ‘strong commitment’ on the part of its CEO Albert Bourla to set prices at levels appropriate to poorer populations. He expected some news on more manufacturers joining the list of providers to the COVAX vaccine facility in coming weeks, he added.”
December 15, 2020
FDA Staff Recommends Watching for Bell’s Palsy in Moderna and Pfizer Vaccine Recipients. CNBC reported:
“U.S. Food and Drug Administration staff recommends monitoring people who get Pfizer or Moderna’s COVID-19 vaccine shots for possible cases of Bell’s palsy, saying it’s not necessarily a side effect but worth watching out for after a handful of trial participants got the condition, which causes half of your face to droop.”
Moderna’s COVID-19 Vaccine Clears First U.S. FDA Hurdle. Al Jazeera reported:
“Moderna’s COVID-19 vaccine appeared to be set for regulatory authorisation this week after US Food and Drug Administration (FDA) staff members did not raise any major new concerns about it in documents released on Tuesday.
“The FDA reviewers said a two-dose regimen of Moderna’s vaccine was highly effective in preventing confirmed cases of COVID-19 and did not raise any specific safety issues with using the vaccine in adults over the age of 18.”
Should Pregnant People Take the Vaccine? FDA and CDC Say That’s Up to Them. Intelligencer reported:
“Over the weekend, after initial fears that pregnant and lactating health-care workers would be barred from receiving the COVID-19 vaccine because of a lack of safety data from clinical trials, the FDA and the CDC instead left the door open for them to choose. What comes next will fall on the institutions distributing the vaccines, and the individual health-care worker having to decide as early as next week whether to get that shot, based on limited information.
Survey Shows Generational Vaccine Attitudes. Medical Economics reported:
“The majority of the three younger reporting groups (56 percent of Gen Z, 57 percent of Millennials, and 60 percent of Gen X) are concerned about getting the flu and COVID-19 at the same time. Meanwhile less than half of the respondents younger than 65 received their flu shot previous to the survey compared to 70 percent among those over 65, the release says.
“More than a quarter of the younger respondents say that they do not plan to receive the flu shot this year, while a majority of those who had not received the shot (68 percent of Gen Z, 80 percent of Millennials, and 78 percent of Gen X) say that they usually do not receive a flu shot, according to the release.”
With Pfizer Shot Spoken for, U.S. Snaps Up 100M More Moderna COVID-19 Vaccine Doses. Fierce Pharma reported:
“The U.S. government on Friday tapped its option to buy additional doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, snapping up 100 million more doses for around $1.68 billion. The deal raises the U.S. order to 200 million doses, enough to vaccinate 100 million people. The shot is up for review at an FDA advisory panel meeting Thursday.
“The latest slate of Moderna shots are set for delivery in the second quarter of 2021. Ahead of that, Moderna plans to ship out some 20 million doses this month and deliver 80 million more in the first quarter, the company said—provided it wins an emergency FDA authorization as expected.”
Trump Scraps Plan to Have Top White House Personnel Among First Vaccinated Against COVID-19. CBS News reported:
“President Trump said Sunday he was reversing an administration directive to vaccinate top government officials against COVID-19, while public distribution of the shot is limited to frontline health workers and people in nursing homes and long-term care facilities. Mr. Trump made the announcement hours after his administration confirmed that senior U.S. officials, including some White House aides who work in close proximity to Mr. Trump and Vice President Pence, would be offered coronavirus vaccines as soon as this week under federal continuity of government plans.”
Report: Cornell University Makes Flu Vaccination Mandatory – But Only for White Students. Law Enforcement Today reported:
“An Ivy League university is requiring that white students receive an annual flu vaccination, while providing an exemption for students belonging to any other race.
“Because of ‘historical injustices and current events,’ Cornell University will grant to ‘people of color’ an exemption from its requirement that all students get a flu vaccination.”
A Century After 1918 Pandemic Killed 675,000 Americans, U.S. Remains a Country Divided Over a COVID-19 Vaccine. New York Daily News reported:
“An Associated Press-NORC Center for Public Affairs Research poll illustrated the stark vaccine schism among Americans, even as the pandemic’s second wave wreaks continued havoc across the country.
“According to the poll, roughly one in four Americans say they will not get vaccinated. And another one in four say they remain unsure if they will or won’t get inoculated when the vaccine is made available via the largest vaccination program in U.S. history.”
Why a COVID-19 Vaccine Doesn’t Mean You Can Stop Wearing a Mask. CNN reported:
“Here’s what the studies don’t yet show. They haven’t looked at whether the vaccine prevents someone from carrying COVID-19 and spreading it to others. It’s possible that someone could get the vaccine but could still be an asymptomatic carrier. They may not show symptoms, but they have the virus in their nasal passageway so that if they’re speaking, breathing, sneezing and so on, they can still transmit it to others.”
December 14, 2020
COVID-19: First Vaccine Given in U.S. as Rollout Begins. BBC reported:
“An intensive care nurse in Long Island, New York is believed to have been the first person to be given the jab.
“Millions of vials of the Pfizer/BioNTech vaccine are being distributed, with 150 hospitals expected to receive doses on Monday.
The U.S. vaccination programme aims to reach 100m people by April.”
Pfizer CEO Albert Bourla Explains Why He Hasn’t Taken COVID-19 Vaccine Yet. New York Post reported:
“‘I haven’t taken it yet and we are having an ethical committee dealing with the question of who is getting it,’ Bourla told CNN’s chief medical correspondent Dr. Sanjay Gupta.”
FDA Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away. New York Times reported:
“The FDA’s decision followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the FDA commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day.
“The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures.”
Pfizer and Moderna Could Score $32 Billion in COVID-19 Vaccine Sales — in 2021 Alone. CNN reported:
“That doesn’t take into account the goodwill boost these companies will receive by helping to end the worst pandemic in a century. That boost is magnified for Moderna (MRNA), a young biotech company that few people had heard of before 2020 that could now be on the cusp of getting its own FDA authorization.
“Pfizer (PFE) by itself is projected to haul in $19 billion in COVID-19 vaccine revenue in 2021, according to Morgan Stanley. That’s on top of an estimated $975 million in 2020 vaccine revenue.”
Facebook Employees Won’t Be Required to Get a COVID-19 Vaccine. Tech Xplore reported:
“CEO Mark Zuckerberg told employees on Thursday that they will not be required to get vaccinated to return to the office once it begins reopening its offices, The Daily Beastfirst reported.
The tech giant confirmed to U.S. TODAY back in May that it doesn’t expect to open most of its offices until July 6 at the earliest.”
CDC Says People With History of Severe Allergic Reactions Can Get COVID-19 Vaccine. STAT reported:
“‘People that do report those types of anaphylactic reactions to other vaccines or injectables — they can still get the vaccine, but they should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefit of vaccination,’ said Sarah Mbaeyi, a medical officer with the CDC’s National Center for Immunization and Respiratory Diseases.”
Australia Scraps COVID-19 Vaccine That Produced H.I.V. False Positives. New York Times reported:
“Australia on Friday canceled a roughly $750 million plan for a large order of a locally developed coronavirus vaccine after the inoculation produced false positive test results for H.I.V. in some volunteers participating in a trial study.
“Of the dozens of coronavirus vaccines being tested worldwide, the Australian one was the first to be abandoned. While its developers said the experimental vaccine had appeared to be safe and effective, the false positives risked undermining trust in the effort to vaccinate the public.”
December 11, 2020
FDA Advisory Panel Gives Green Light to Pfizer Vaccine. New York Times reported:
“The FDA’s vaccine advisory panel, composed of independent scientific experts, infectious disease doctors and statisticians, voted 17 to 4, with one member abstaining, in favor of emergency authorization for people 16 and older. With rare exceptions, the FDA follows the advice of its advisory panels.
“With this formal blessing, the nation may finally begin to slow the spread of the virus just as infections and deaths surge, reaching a record of more than 3,000 daily deaths on Wednesday. The FDA is expected to grant an emergency use authorization on Saturday, according to people familiar with the agency’s planning, though they cautioned that last-minute legal or bureaucratic requirements could push the announcement to Sunday or later.”
Why Paying People to Get the Coronavirus Vaccine Won’t Work. The Conversation reported:
“The idea of monetary incentives seems straightforward: Pay people to get vaccinated. One of the earliest proponents, economist Robert Litan, called the idea an ‘adult version of the doctor handing out candy to children.’”
“Litan suggested that the government should pay $1,000 to each person who receives a COVID-19 vaccine. He admitted in his proposal that he had not relied on any studies or data to get to this number, explaining that the proposed payment amount was a ‘hunch.’
Many Black Americans, Republicans, Women Aren’t Sure About Taking A COVID-19 Vaccine. FiveThirtyEight reported:
“Overall, 60 percent of American adults said that they would ‘definitely’ (29 percent) or ‘probably’ (31 percent) take a vaccine ‘if it were available today,’ according to a Pew Research Center poll conducted Nov. 18-29. Eighteen percent said that they would ‘definitely not’ take the vaccine, and 21 percent said that they would ‘probably not.’ Other polls have revealed similar findings (for the most part).
“A Morning Consult survey on behalf of National Geographic conducted Nov. 20-23 found 61 percent of Americans were either ‘likely’ or ‘somewhat likely’ to take a vaccine if it were approved by the FDA and made available to them. In that poll, 30 percent said they were unlikely to take the vaccine, including 19 percent who indicated they were ‘very unlikely.’ And a Gallup poll conducted Nov. 16-29 showed roughly the same splits.”
COVID-19 Vaccine Candidate Scrapped After False Positives on HIV Tests. Wall Street Journal reported:
“A COVID-19 vaccine candidate in Australia has been scrapped because recipients returned false positives on certain HIV tests, underscoring the difficulties scientists face in rapidly developing an inoculation for the coronavirus.
“The vaccine candidate, called v451, was being jointly developed by the University of Queensland and CSL Ltd. , an Australia-based biopharma company that also runs blood-collection centers in the U.S. The Australian government had agreed to buy 51 million doses.”
Canada Approves Vaccine and Could Start Shots Next Week. New York Times reported:
“The regulatory agency Health Canada approved the same vaccine, created by the American company Pfizer and a German firm, BioNTech, that was authorized in Britain and is up for a decision in the United States. Canada’s move marks another milestone in the global fight against a pandemic that has killed more than 1.5 million people, continues to spread rapidly and has driven the world into a deep economic crisis.
“Health Canada said that it had completed a rigorous, independent review of the data from clinical trials on the vaccine’s safety and effectiveness, which involved tens of thousands of people — the same kind of scrutiny applied by the U.S. Food and Drug Administration. British regulators, in giving emergency approval, relied largely on Pfizer’s own analysis of that data, the standard approach in much of the world. Bahrain approved the same vaccine on Friday.”
Sanofi Suffers Major Setback in Development of a COVID-19 vaccine. STAT reported:
“The problem relates to inadequate results in older adults in Sanofi’s Phase 1/2 trial, which the company traced back to an inadequate formulation of their vaccine, Su-Peing Ng, global medical head for Sanofi Vaccines, told STAT in an interview.
“Ng said both Sanofi and GSK are committed to continuing work on the vaccine, and plan to begin a Phase 2b trial in February.”
CVS, Walgreens Will Be First to Give Out COVID-19 Vaccines. WSBTV reported:
“The pharmacies have thousands of workers ready to hit the road, to set up mobile clinics inside nursing homes and care facilities all over the country.”
The FDA’s Green Light for a Vaccine Might Tank Ongoing Trials. Wired reported:
“Still, it’s not like Pfizer’s vaccine is going to be widely available for a while. It could be next summer before the company can provide the U.S. government with enough doses to vaccinate 100 million people. That should offer some additional incentive to study participants to stay in. And it means the bigger effect of the EUA decision will likely be for the nearly 60 vaccine candidates manufactured by other pharma companies that are currently being studied in humans. If a working vaccine is made available, fewer people may volunteer to test the competitors.
“That’s a problem because, as WIRED’s Adam Rogers has written, it’s going to take more than one or two or even three vaccines to exit this pandemic. Public health authorities want to avoid a situation in which the early success of effective but difficult-to-distribute vaccines slows the progress or even cripples the development of other shots that travel and store more easily, can be made more cheaply, or work better in certain subsets of the population.”
Massachusetts To Deliver COVID Vaccine To Residents In Three Phases Beginning In December. CBS Boston reported:
“The first round of coronavirus vaccine shipments to Massachusetts is scheduled to begin around December 15. That shipment will include 59,475 doses of Pfizer’s vaccine that will be delivered to 21 hospitals in eight counties, and to the Department of Public Health immunization lab.
“From there, doses will be sent to 74 hospitals in 14 counties for frontline workers. The next 40,000 doses will be distributed to the Federal Pharmacy Program for staff and residents of skilled nursing facilities, rest homes, and assisting living residences.”
AstraZeneca to Work on COVID Vaccine Combinations with Russia’s Sputnik V Developers. CNBC reported:
“British pharmaceutical giant AstraZeneca said Friday it would soon start work with Russia’s Gamaleya Institute to investigate whether their two coronavirus vaccine candidates could be successfully combined.
“It comes after the developers of the Sputnik V COVID-19 vaccine approached AstraZeneca via Twitter late last month to ask whether they should try combining the two common cold virus-based vaccines to boost efficacy.”
White House Threatens to Use Defense Production Act to Ensure Coronavirus Vaccine Allocation. Fox News reported:
“Health and Human Services Secretary Alex Azar said on Wednesday morning that the Trump administration may use the Defense Production Act (DPA) to ensure that the government can acquire enough vaccine doses to help stem the tide of the coronavirus pandemic in the U.S.
“Azar, discussing the U.S. government’s efforts to widely distribute a coronavirus vaccine, said that the U.S. was interested in buying 500 million additional doses of the Pfizer coronavirus vaccine and that the government was waiting for the company to commit to a certain delivery date on those doses.”
What May Happen to COVID-19 Vaccine Volunteers Who Got Placebo. ABC News reported:
“Under normal circumstances, an experiment like this would end as soon as a drug or vaccine is approved, and everyone who got a placebo would be offered the real thing. But these are not normal times. The COVID-19 vaccine would be made available through a special “emergency use authorization,” which is not the same as an FDA approval.
“With that emergency use authorization imminent, many bioethicists argue those who bravely volunteered should be immediately eligible to get the real vaccine. But others argue the nearly 44,000-person experiment should continue as if nothing had changed to ensure researchers can continue to study still-unanswered questions about the vaccine.”
Moderna Begins Testing COVID-19 Vaccine on U.S. Adolescents. ABC News reported:
“The company, which made one of two vaccines expected to be approved soon for adult use in the U.S., said it plans to enroll 3,000 U.S. kids as young as 12 in the trial.
“So far, there have only been a handful of attempts around the world to start exploring if any of the experimental coronavirus shots being pushed for adults also can protect children. Some U.S. pediatricians are worried they may not know if any of the shots work for young children in time for the next school year.”
Breaking: CHD Responds to News of Life-Threatening Reaction to Pfizer COVID Vaccine. Will Regulators Take Action? The Defender reported:
“On Aug. 26, Children’s Health Defense (CHD) sent a letter to Dr. Jerry Menikoff, director office for Human Research Protections Dept. of Health and Human Services regarding the Phase III Moderna mRNA-1273 vaccine. The letter requested the Office for Human Research Protections investigate the use of polyethylene glycol (PEG) in Moderna’s COVID-19 mRNA vaccine. Pfizer’s COVID vaccine, which also uses mRNA technology, also contains PEG.”
“Approximately 8% of the U.S. population has highly elevated levels of anti-PEG antibodies. The concerns we laid out in our letter about the Moderna vaccine were related to the fact that injecting a PEG-containing vaccine into individuals with pre-existing PEG antibodies could lead to life-threatening anaphylaxis.”
AP-NORC Poll: Only Half in U.S. Want Shots as Vaccine Nears. Associated Press reported:
“As states frantically prepare to begin months of vaccinations that could end the pandemic, a new poll finds only about half of Americans are ready to roll up their sleeves when their turn comes.
“The survey from The Associated Press-NORC Center for Public Affairs Research shows about a quarter of U.S. adults aren’t sure if they want to get vaccinated against the coronavirus. Roughly another quarter say they won’t.”
Worldwide Distribution of COVID-19 Vaccines Is Crucial for the Economy, Melinda Gates Says. CNN reported:
“’Everybody needs this vaccine,’ Gates, co-chair of the Bill and Melinda Gates Foundation, told CNN’s Poppy Harlow in a broadcast interview Thursday. ‘If we only get it to the high-income countries, this disease is going to bounce around. We’re going to see twice as many deaths. And our recovery of our economies is going to be much slower than if we get the vaccine out to everybody.’
“The Gates Foundation on Thursday said it plans to commit an additional $250 million to support the “research, development and equitable delivery” of tools to fight Covid-19, including tests, treatments and vaccines. The announcement brings the group’s total commitments to the global Covid-19 response to $1.75 billion.”
Hackers Steal Pfizer/BioNTech COVID-19 Vaccine Data in Europe, Companies Say. Reuters reported:
“U.S. drugmaker Pfizer and its German partner BioNTech said on Wednesday that documents related to development of their COVID-19 vaccine had been “unlawfully accessed” in a cyberattack on Europe’s medicines regulator.
“The European Medicines Agency (EMA), which assesses medicines and vaccines for the European Union, said hours earlier it had been targeted in a cyberattack. It gave no further details.
“Pfizer and BioNTech said they did not believe any personal data of trial participants had been compromised and EMA “has assured us that the cyber attack will have no impact on the timeline for its review.”
FBI Warns of COVID-19 Vaccine Scams. ABC News reported:
“In October, the World Health Organization found a fake flu vaccine in Mexico, according to EUROPOL, the European Union’s law enforcement arm. EUROPOL worries the same could happen with the COVID-19 vaccine.
“’The same scenario is also likely to happen when COVID-19 vaccines do become available,’ the agency said in a press release. ‘Similar to the fake influenza vaccine encountered in Mexico, counterfeit COVID-19 vaccines may represent a significant public health threat if they are ineffective at best or toxic at worst, given their production in underground labs without hygiene standards.’”
Google to Add COVID-19 Vaccine Information Panels to Search. TechCrunch reported:
“The feature itself will appear at the top of Google.com searches for COVID-19 vaccines and will present the authoritative information in a box above the search results, linking to the health authority as the source. The panel will also have two tabs. One will be the overview of the vaccine, which appears above Top Stories and links to Local and National resources, like government websites. The other will organize news related to the vaccine under a separate section.
“Google positioned the new search panels as one way it’s helping to address vaccine misinformation and hesitance at scale.”
Will I Have to Wear a Mask Once I Get the COVID-19 Vaccine? CBS News reported:
“With three potential coronavirus vaccines showing promise, and two awaiting authorization from the FDA, state and federal officials have begun announcing ambitious distribution plans to get vaccines to millions of Americans starting as soon as next week. It will take months to reach everyone who wants the shots, but some optimistic Americans are already asking: Will I still have to wear a mask after I’m vaccinated?
“’Eventually I think we won’t, but I think until we know that this vaccine is working, we are going to have to wear a mask,’” pediatrician Dr. Dyan Hes said on CBSN.
Chicago Aims to Offer All Adults Free Covid Vaccine in 2021. Bloomberg reported:
“Chicago expects to get thousands of coronavirus vaccine doses this month and is aiming to offer them free of charge to all adult residents in 2021, city officials said Wednesday.
“After Pfizer Inc. and Moderna Inc. receive emergency federal approvals and the city gets guidance from an immunization advisory committee, Chicago can move forward with its vaccine rollout plan. The city will allocate its initial doses to its 34 hospitals the week of Dec. 14, officials said in a press release on Wednesday. Health-care workers who treat Covid patients or conduct procedures that put them at high risk for spread will be the first to receive the vaccine. Chicago has about 400,000 health workers including doctors, nurses, and other hospital staff.”
Many Black Americans Don’t Trust COVID-19 Vaccine. It’s Important to Understand Why. Yahoo!News reported:
“Looking at Black Americans specifically, one of the most rigorous surveys on this topic found that only 14% “mostly or completely trust” a COVID-19 vaccine will be safe, according to COVID Collaborative, a national, bipartisan organization focused on ending the pandemic. It also found that less than one-fifth, 18%, of Black Americans ‘mostly or completely trust’ a COVID-19 vaccine will be effective.
“Asked about the reason for vaccine hesitancy in the Black community, McDougle was quick to call out that many white people are hesitant, too. But for Black people, he said, the impact of the Tuskegee Study, Henrietta Lacks and Dr. J. Marion Sims are still felt.”
Berkeley Wants Teachers to Be Among First to Get COVID vaccine. Kron4 reported:
“One East Bay school district is calling on state leaders to let teachers be among the first to receive the new vaccine.
“They say teachers are essential workers and protecting them against COVID-19 would clear a huge hurdle in getting children back into the classrooms.”
COVID-19 Vaccine Distribution Must Prioritize Prisoners. The Virus Is Killing More of Them. NBC News reported:
“Indeed, many major health organizations, like the American Medical Association and John Hopkins’ Center for Health Security argue for vaccinating incarcerated and detained persons quickly because of the reality of the conditions in which they live; in prison, they are unable to maintain social distancing and often have no access to proper medical care. Congregate settings like assisted living and nursing home facilities are already top of the list; it would follow that detention centers and prisons should also be among the first places vaccines are distributed.”
December 9, 2020
NHS Told Not to Give Pfizer Vaccine to Extreme Allergy Sufferers After Two People Have Reaction. The Guardian reported:
“Both of the NHS staff carry adrenaline autoinjectors, of which the best known brand is the EpiPen, suggesting they have suffered reactions in the past. These administer a swift adrenaline boost to counter allergic reactions which occur when some people, for instance, eat nuts.”
WHO Against Mandatory COVID Vaccines. Channel News Asia reported:
“The WHO said it would be down to individual countries as to how they want to conduct their vaccination campaigns against the coronavirus pandemic.
“But the UN health agency insisted making it mandatory to get immunised against the disease would be the wrong road to take, adding there were examples in the past of mandating vaccines use only to see it backfire with greater opposition to them.”
New York Legislation Could Make COVID-19 Vaccination Mandatory. Fox News reported:
“Assemblymember Linda Rosenthal, who represents parts of Manhattan’s West Side, earlier this month introduced a bill that would require the state to “safely and effectively” distribute an FDA-approved vaccine “in accordance with the department [of health]’s COVID-19 vaccination administration program,” according to the language of the legislation.”
FDA Says Pfizer’s COVID Vaccine Is Safe and Effective. But Trial Participants Warn of Intense Symptoms After Second Shot. CNBC reported:
“Others experienced headaches and fatigue.
“The FDA said that while side effects of the Pfizer vaccine are common, there are ‘no specific safety concerns identified that would preclude issuance of an EUA.”
Biden Plans To Give 50 Million Americans COVID-19 Vaccinations In His First 100 Days. BuzzFeed News reported:
“President-elect Joe Biden is planning a vaccination program that would inoculate 50 million Americans against COVID-19 in his first 100 days in office.
“’This team will help get at least 100 million COVID-19 vaccine shots into the arms of Americans in 100 days,’ the president-elect said in a speech on Tuesday. A transition team official clarified afterward that 50 million Americans would be vaccinated — because the two most promising early vaccines require two shots per person.”
Oxford-AstraZeneca COVID Vaccine to immunize the planet ‘more effectively,’ Lancet editor says. NBC News reported:
“‘The Oxford AstraZeneca vaccine is the vaccine right now that is going to be able to immunize the planet more effectively, more rapidly than any other vaccine we have,’ Richard Horton, editor-in-chief of The Lancet, told CNBC’s ‘Street Signs Europe’ on Wednesday.
“Horton, a trained doctor himself, argued it is important to think about vaccine immunization on a global scale ‘because even if we immunize one country, the threat then is you reintroduce the virus from another country that is not protected.’”
Blunders Eroded U.S. Confidence in Early Vaccine Front-Runner. New York Times reported:
“On the afternoon of Sept. 8, AstraZeneca officials had a conference call with the Food and Drug Administration. The discussion covered important ground: What would AstraZeneca need to do to win the FDA’s blessing for the coronavirus vaccine it was developing with the University of Oxford?
“But the AstraZeneca representatives neglected to mention a crucial development: Two days earlier, the company had quietly halted trials of its vaccine around the world, including a late-stage study in the United States. It acted after a participant in Britain fell ill.”
Pfizer’s Vaccine Offers Strong Protection After First Dose. New York Times reported:
“The F.D.A. concluded that there were no “meaningful imbalances” in serious health complications, known as adverse events, between the two groups. The agency noted that four people in the vaccinated group experienced a form of facial paralysis called Bell’s palsy, with no cases in the placebo group. The difference between the two groups wasn’t meaningful, and the rate in the vaccinated group was not significantly higher than in the general population.”
China State-Backed COVID Vaccine Has 86% Efficacy, UAE Says. Bloomberg reported:
“China’s state-backed coronavirus vaccine protected 86% of people against COVID-19 in trials conducted in the United Arab Emirates, state media there reported, giving credence to the quickly developed shot that Beijing intends to distribute around the developing world.
“The data was from trials that included 31,000 volunteers in the UAE, which found the vaccine was highly effective in preventing moderate and severe cases of COVID-19 and had no serious safety concerns, according to the report, which cited the country’s Ministry of Health and Prevention.”
December 8, 2020
It’s True: Workers Can Be Fired for Refusing to Get a COVID-19 Vaccine. WKYC Studios Reported:
“While most Ohioans will still have to wait months to get a coronavirus vaccine, what if you don’t want one? Could you even be fired from your job if you refuse?
“Legal experts say yes.
“’Employers can require their at-will employees to get a vaccine. That’s already law,’ said Rema Ina, employment attorney at Cleveland’s Gallagher Sharp law firm, adding that many hospitals already require health care workers to get flu vaccinations as a condition of employment.”
First Britons Receive COVID-19 Vaccine, a Landmark Moment in the Pandemic. CNN reported:
“The first Briton to get the Pfizer/BioNTech vaccine — 90-year-old Margaret Keenan — received the first of two doses at 6:31 a.m. local time on Tuesday at University Hospital in Coventry, less than a week after the UK became the first country to approve it.”
Doctors Are Skeptical of Pricey Drug Given Emergency Approval for COVID. New York Times reported:
“In mid-November, an arthritis drug with a tricky name hit a pandemic milestone — then slipped back into relative obscurity.
“The drug, baricitinib, was granted an emergency authorization by the Food and Drug Administration to treat a subset of hospitalized COVID-19 patients in combination with another medication, the antiviral remdesivir. It is one of only a handful of treatments to have earned the agency’s green light.”
FDA Releases Detailed Data on Effectiveness, Risks of Pfizer’s COVID-19 Vaccine. New York Post reported:
“Pfizer’s experimental coronavirus vaccine is highly effective and poses no safety risks that would prevent it from being cleared for emergency use, Food and Drug Administration scientists said Tuesday.
“FDA staffers detailed their findings in a 53-page report ahead of a Thursday meeting at which the agency’s vaccine advisory committee will consider Pfizer’s application for an emergency use authorization, which could pave the way for millions of high-risk Americans to be inoculated by the end of the year.”
55% of FDNY Firefighters Wouldn’t Get a COVID-19 Vaccine If Offered by Department, Poll Finds. CNN reported:
“Despite research that shows firefighters were 15 times more likely to be infected, a majority of those who took the poll declined the offer of a vaccine.
“Over 2,000 firefighters, or about 25% of the department’s approximately 8,200 members, responded to the poll, according to Uniformed Firefighters Association President Andrew Ansbro.”
CDC Lowers COVID-19 Quarantine Time in Effort to Increase Compliance. Very Well Health reported:
“The Centers for Disease Control and Prevention (CDC) has released alternative recommendations for the length of time a person should quarantine following exposure to a person who has been diagnosed with COVID-19.
“According to the new guidelines, close contacts of these individuals should quarantine for seven to 10 days after exposure, which is a decrease from the initially recommended 14 days. These individuals can then end their quarantines after seven days if they receive a negative test, or 10 days if they do not get tested and ‘no symptoms have been reported during daily monitoring,’ the CDC noted on its website.”
Why Vaccinate Our Most Frail? Odd Vote Out Shows the Dilemma. CNN reported.
“When shots begin to go into arms of residents, Moore said Americans need to understand that deaths may occur that won’t necessarily have anything to do with the vaccine.
“’We would not at all be surprised to see, coincidentally, vaccination happening and then having someone pass away a short time after they receive a vaccine, not because it has anything to do with the vaccination but just because that’s the place where people at the end of their lives reside,’ Moore said”
Fortune or foresight? AstraZeneca and Oxford’s Stories Clash on COVID-19 Vaccine. Reuters reported:
“AstraZeneca and Oxford University have given conflicting accounts of how they came upon the most effective dosing pattern for their COVID-19 vaccine, a rare instance of public dissension between major institutions collaborating on a pivotal project.
“The discrepancy, reported for the first time by Reuters, centres on the regimen administered to a smaller group of volunteers in the late-stage trials, of half a dose followed by a full dose. This diverged from the original plan of two full doses, given to the majority of participants.”
Tennessee Bill Would Prohibit Authorities From Forcing COVID Vaccine on Someone Against Their Will. WREG-TV Memphis reported:
“East Tennessee Rep. Bud Hulsey of Kingsport proposed a bill that prohibits state and local authorities from forcing or requiring someone to receive the COVID-19 vaccine against their will.
“The legislation reads, ‘A law enforcement agency or governmental entity of this state or a local government, or the governor or chief executive of a local government by executive order, shall not force, require, or coerce a person to receive an immunization or vaccination for COVID-19 against the person’s will.’”
COVID-19 Vaccine Rollout Faces Public Concerns Over Safety. The Wall Street Journal reported:
“Governments are accelerating toward approving the first vaccines to contain COVID-19, but public anxiety over the safety of the doses is threatening to undermine those efforts.”
Trump Officials Push Ambitious Vaccine Timeline as California Locks Down. The New York Times reported:
“The Trump administration’s top health officials outlined an ambitious timetable on Sunday for distributing the first coronavirus vaccinations to as many as 24 million people by mid-January, even as the accelerating toll of the pandemic filled more hospital beds across the United States and prompted new shutdown orders in much of California.
Doctor Who Volunteered for Moderna Study Felt ‘Lousy’ After Second Shot, but Touts Vaccine. The Boston Globe reported:
“Jorge Arroyo isn’t certain whether he was injected with Moderna’s coronavirus vaccine or a placebo when he volunteered to receive two shots four weeks apart during the summer. Participants and researchers in the study at Brigham and Women’s Hospital were kept in the dark to eliminate the power of suggestion.
“But to Arroyo, it sure felt like he got the real thing.
“The Harvard-affiliated ophthalmologist ― one of about 30,000 participants in the Cambridge biotech’s nationwide trial ― says he began feeling ill about 10 hours following the second shot. The symptoms included body aches, slight nausea, and chills. What’s more, his husband, who also participated in the trial, had a similar reaction.”
December 7, 2020
Pfizer Chairman: We’re Not Sure if Someone Can Transmit Virus After Vaccination. The Hill reported:
“Pfizer chairman Albert Bourla told Dateline host Lester Holt that the pharmaceutical company was ‘not certain’ if the vaccine prevented the coronavirus from being transmitted, saying, ‘This is something that needs to be examined.’”
Anti-Vaccine Doctor Invited to Testify Before Senate Committee. New York Times reported:
“A doctor who is skeptical of coronavirus vaccines and promotes the anti-malaria drug hydroxychloroquine as a COVID-19 treatment will be the lead witness at a Senate Homeland Security and Governmental Affairs Committee hearing on Tuesday, prompting criticism from Democrats who say Republicans should not give a platform to someone who spreads conspiracy theories.
“Dr. Jane M. Orient is the executive director of the Association of American Physicians and Surgeons, a group that opposes government involvement in medicine and views federal vaccine mandates as a violation of human rights.
“‘A public health threat is the rationale for the policy on mandatory vaccines. But how much of a threat is required to justify forcing people to accept government-imposed risks?’ Dr. Orient wrote in a statement to the Senate last year, calling vaccine mandates ‘a serious intrusion into individual liberty, autonomy and parental decisions.’”
Airports Reject Vaccine Requirement as Travel Debate Intensifies. Reuters reported:
“Airports Council International, which represents airports worldwide, joined most airlines in calling for a choice between testing or vaccination, fearing a blanket rule imposing pre-flight inoculation would be as disruptive as quarantines.
“Qantas Airways triggered the debate last week when it said a COVID-19 vaccination would be necessary for passengers on its international flights, which remain largely idle because of Australia’s strict border controls.”
‘Black Panther’ Star Slammed for Sharing Video Casting Doubt on COVID Vaccine. Miami Herald reported:
“Black Panther” star Letitia Wright says she is being “canceled” after sharing a video on Twitter that casts doubt on the COVID-19 vaccine.
Yes, Some Americans May Be Required to Get a COVID-19 Vaccine but Not by the Federal Government. USA Today reported:
“A big question remains: Will Americans be required to get vaccinated?
“For some, the short answer is yes, public health and legal experts say. But a mandate is not likely anytime soon, and likely not to come from the federal government. Instead, employers and states may condition return or access to workplaces, schools and colleges upon getting the vaccine and mandate it once the FDA issues full approval, potentially months later.
“’It’s much more likely that a private organization or company will require you to be vaccinated to get certain access to places,” said Arthur Caplan, a professor of bioethics at the New York University Grossman School of Medicine. ‘People worry about the president, governor, or county executive telling them what to do. I don’t think that’s going to happen.’”
Vaccine Opponents Rebrand as Rollout of COVID-19 Shots Looms. Politico reported:
“Longstanding vaccine opponents have rebranded themselves, forging alliances with religious and civil liberties groups to protest stay-at-home orders, business closures and mask mandates in recent months. They argue that those policies, designed to stop the spread of a deadly virus, violate their rights.
“Now this emerging coalition, which draws from both ends of the political spectrum, is turning its attention to coronavirus vaccines — and any states or employers who might try to make getting the shots mandatory. These anti-vaccine activists are seeking to capitalize on resistance to existing public health measures along with concerns that the hunt for COVID-19 shots has been politicized.
“‘With a lot of focus on COVID-19, we’re hoping to get something on protection on the COVID-19 vaccine specifically,’ said Stephanie Stock, president of the Ohio Advocates for Medical Freedom, which opposes any type of mandatory vaccination.”
FDA Could Authorize Coronavirus Vaccine ‘Within Days,’ if Hearing Goes Well: HHS Secretary. ABC News reported:
“Alex Azar, the U.S. Department of Health and Human Services secretary, offered an optimistic outlook Sunday on the timeline of the first coronavirus vaccine rollout, previewing that authorization is a possibility next week, following the outcome of a Food and Drug Administration hearing.
“’If things are on track, the advisory committee goes well, I believe we could see FDA authorization within days,’ Secretary Alex Azar told ABC News Chief Anchor George Stephanopoulos on ‘This Week,’ referencing Thursday’s hearing on Pfizer’s vaccine. ‘But it’s going to go according to FDA gold-standard processes … and I’m going to make sure it does.’”
Dr. Birx: COVID-19 Vaccine Won’t ‘Save Us From This Current Surge.’ New York Post reported:
“Dr. Deborah Birx, the White House coronavirus response coordinator, warned on Sunday that a vaccine that could be authorized for use as early as this week is crucial but it will not be able to protect Americans from the recent hike in COVID cases across the country.
“‘The vaccine is critical, but it’s not going to save us from this current surge. Only we can save us from this current surge. And we know precisely what to do,’ Birx said on NBC News’ ‘Meet the Press.’”
UK Prepares to Give First COVID-19 vaccinations as the world watches. CNN reported:
“Vaccinations are set to begin on Tuesday in England, Wales and Scotland. Northern Ireland said it would start administering the vaccine early in the week but did not specify which day.
“The process, which is complicated by the need to store the Pfizer/BioNTech vaccine under strict conditions and give each recipient two doses, three weeks apart, will be closely watched from around the world.”
Iran’s Top Banker Says U.S. Blocking COVID-19 Vaccine Purchase. Al Jazeera reported:
“The United States is actively trying to prevent Iran’s efforts to buy a COVID-19 vaccine through COVAX, a global initiative undertaken by the World Health Organization, according to the chief of Iran’s central bank.
“Abdolnasser Hemmati on Monday said it must be “recorded in historical memory” that Iranian efforts to buy a vaccine through COVAX have been hampered due to money transfer issues arising due to the sanctions imposed by the US against Iran.”
Indonesia Gets First Batch of Vaccine From China’s Sinovac. Bloomberg reported:
“As many as 1.2 million doses of the vaccine arrived late on Sunday and the government expects to receive another shipment of 1.8 million in early January, according to Indonesian President Joko Widodo. Sinovac will also ship raw material for 45 million doses, which Indonesia’s state pharmaceutical firm PT Bio Farma will process locally, Widodo said in a statement.”
December 4, 2020
Anthony Fauci Slams U.K.’s Speedy Review of Pfizer, BioNTech COVID Shot. Fierce Pharma reported:
“‘If you go quickly and you do it superficially, people are not going to want to get vaccinated,’ National Institute of Allergy and Infectious Diseases Director Anthony Fauci, M.D., told Fox News. ‘We have the gold standard of a regulatory approach with the FDA.’
“The U.K.’s Medicines and Healthcare products Regulatory Authority (MHRA) ‘did not do it as carefully,’ he added. Less than a day after making his remarks, Fauci apologized, telling the BBC he has ‘great faith’ in U.K. regulators.”
COVID-19 Vaccines May Not Work on Nursing Home Patients. Is It Worth the Risk to Try Anyway? Los Angeles Times reported:
“It’s a profile starkly different than that of patients who live in long-term care facilities. Retired from active life, they are on the receiving end of medical care. Indeed, they are so medically fragile that some fear the vaccine itself could hasten their demise.
“If vaccines for diseases like the flu are any guide, the new COVID-19 shots may not be particularly effective in nursing home residents. The aging immune system is notoriously difficult to rouse with vaccines.”
Vaccines’ Side Effects Risk Sidelining Health Workers While Cases Surge. Bloomberg reported:
“COVID-19 vaccine side-effects that range from fevers and chills to headaches and joint pain could keep some doctors and nurses from working amid a nationwide surge in hospitalizations.
“Health systems are gearing up to vaccinate key hospital staff with the Pfizer Inc. and Moderna Inc. coronavirus shots, which could start shipping in the U.S. in a matter of weeks, pending emergency-use authorizations.”
Coronavirus Vaccines Coming, but Johns Hopkins Experts Say Some Vital Questions Remain Unanswered. Baltimore Sun reported:
“But even if vaccines become widely available before the end of the year, many more months of study, clinical trial testing and research will be required before vaccines can be deemed effective, said Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, during a virtual media briefing Thursday.”
CDC to Encourage ‘Vaccinated for COVID-19’ Buttons. ABC News reported:
“The Centers for Disease Control and Prevention is planning to offer health care providers a template they can use to print buttons or stickers that would advertise a person’s vaccination status. The idea is that the button would be handed out to patients after they receive their vaccination shots.
‘Absolutely Normal’: COVID Vaccine Side Effects Are No Reason to Avoid the Shots, Doctors Say. Washington Post reported:
“Ahead of the anticipated distribution of Moderna’s two-dose vaccine and a similar vaccine developed by Pfizer and German biotechnology company BioNTech, which could be coming in a matter of weeks, experts have stressed the importance of transparent messaging in ensuring wide public acceptance and completion of the vaccination regimens. Though a full detailed analysis of the safety profile of the vaccines is forthcoming and will be a topic of discussion at the Food and Drug Administration’s advisory committee meetings this month, the drugmakers’ disclosures about the possible side effects coupled with anecdotal reports from trial participants have prompted concern among some experts that people may be hesitant to get vaccinated or won’t come back for their second dose.”
Ex-Presidents Would Get Vaccine Publicly to Boost Confidence. Associated Press reported:
“Three former presidents say they’d be willing to take a coronavirus vaccine publicly, once one becomes available, to encourage all Americans to get inoculated against a disease that has already killed more than 275,000 people nationwide.
“Former President Barack Obama said during an episode of SiriusXM’s ‘The Joe Madison Show’ airing Thursday, ‘I promise you that when it’s been made for people who are less at risk, I will be taking it.’”
Incomplete Data Stalls Swiss Authorisation of COVID-19 Vaccines. SWI reported:
“The regulator said important data on safety, efficacy and quality are still missing. It has reached out to the manufacturers, who provided data from their studies.
“‘We lack data on the effectiveness of the clinical trials and on the important subgroups that participated in these large studies,’ said Claus Bolte, head of the authorisation division at Swissmedic, at a press briefing on Tuesday organised by the Federal Office of Public Health.”
How COVID-19 Highlights the Uncertainty of Medical Testing. Kaiser Health News reported:
“‘People think a positive test equals disease and a negative test equals not disease,’ said Dr. Deborah Korenstein, who heads the general medicine division at Memorial Sloan Kettering Cancer Center in New York City. ‘We’ve seen the damage of that in so many ways with COVID.’”
MDA Wants Neuromuscular Disease Patients to Have Early Access to COVID-19 Vaccine. ALS News Today reported:
“The Muscular Dystrophy Association (MDA) is encouraging the U.S. Centers for Disease Control and Prevention (CDC) to recommend that people living with neuromuscular diseases (NMDs) have early access to any federally approved COVID-19 vaccine.
“The MDA made its request in a letter to members of the CDC Advisory Committee on Immunization Practices (ACIP), who are helping to guide the allocation and distribution of the COVID-19 vaccine. The MDA represents more than 300,000 U.S. residents who have one of some 40 NMDs.”
Spit in a Tube and Mail It In: A New Frontier in Coronavirus Testing. New York Times reported:
“Testing has long been one of the keys to controlling the spread of a virus that with the onset of winter is entering its most dangerous phase. Yet even as cases per capita have rocketed, securing a test has become enough of an ordeal that many people have been dissuaded from even trying.
“That has begun to change in recent weeks as a handful of communities across the country have rolled out the first do-it-yourself home saliva tests, which require users to simply dribble into a test tube, seal it and send it to a lab.”
First ‘Mass Air Shipment’ of Pfizer’s COVID Vaccine Arrives as Airlines Prepare for More. CNBC reported:
“The Federal Aviation Administration said it supported the “first mass air shipment” of COVID-19 vaccines, as pharmaceutical companies and airlines prepare networks for broad distribution.
December 3, 2020
Vaccination Cards Will Be Issued to Everyone Getting COVID-19 Vaccine, Health Officials Say. CNN reported:
“’Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due,’Moore said. ‘Let’s do the simple, easy thing first. Everyone’s going to get that.’
“Vaccination clinics will also be reporting to their state immunization registries what vaccine was given, so that, for example, an entity could run a query if it didn’t know where a patient got a first dose.”
Come for Your Eye Exam, Leave With a Band-Aid on Your Arm. Kaiser Health News reported:
“In California, the professional organizations representing dentists and optometrists are in talks with state officials to expand their job descriptions to include administering vaccines. Oregon has already begun training and certifying dentists to give vaccines. And at least half the states have considered allowing dentists to administer COVID vaccines once they’re available, according to the American Association of Dental Boards.
“That list is likely to grow, because the U.S. Centers for Medicare & Medicaid Services recommended in October that states consider expanding their list of vaccine providers.”
‘You Need to Assume You Became Infected’ at Thanksgiving: White House Task Force Warning. ABC News reported:
“Americans who celebrated Thanksgiving with other people outside their household should assume they are infectious and a ‘dangerous to others,’ the White House Coronavirus Task Force is warning in a startling new report obtained by ABC News.
“Delivered Nov. 29 to the nation’s governors, but not released publicly, President Donald Trump’s top pandemic advisers said it’s up to state and local public health officials to alert the public as COVID-19 cases hit an all-time high.”
Support for Mandatory COVID Vaccine Down From 72% to 59% in Canada. LifeSiteNews reported:
“The poll also asked respondents to give their opinions on the speed of COVID-19 vaccine development. The vast majority, 71 percent, said taking a vaccine that was approved so fast makes them nervous, with 69 percent saying they have concerns for potential harmful long-term effects of the vaccine.
“When respondents were given detailed conditions under which they would agree to take a COVID-19 vaccine “without hesitation once approved,” only 19 percent said they would be willing to do so.”
Health Advisers Rename ‘Adverse Reactions’ to COVID-19 Vaccine. Mercola.com reported:
“If you start hearing about ‘immune responses’ that many people have in conjunction with the COVID-19 vaccine, be aware: This is the new name for adverse reactions. In other words, the COVID-19 vaccine no longer has ‘adverse reactions’ but, rather, the bad side effects you feel — some of which could be very serious — are now called “immune responses.”
“This information was buried at the bottom of an article by CNBC in connection with the news that 10% to 15% of vaccine recipients will suffer ‘significantly” noticeable’ side effects. Some health officials are concerned that the connotation of ‘side effects’ and ‘adverse reactions’ may be off-putting to the public, so in an attempt to reprogram how you think about the side effects, one health practitioner suggested changing the definition of “adverse reactions” to ‘immune response.’”
When Will Children Get Coronavirus vaccine? Not in Time for New School Year, Experts Fear. Washington Post reported:
“On Sunday, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, acknowledged it is going to take time, perhaps even months, before those younger than 18 can get a coronavirus vaccine, as trials to test the vaccine candidates’ immunogenicity are either underway or have yet to begin. Pfizer, which is developing a vaccine with German partner BioNTech, announced in October they were expanding testing of their vaccine to those 12 and older. A similar announcement is expected soon from Moderna, which has partnered with the National Institutes of Health on an experimental vaccine, with Fauci hinting an expedited process to test the vaccine in children would begin ‘very likely in January.’”
Many Trial Volunteers Got Placebo Vaccines. Do They Now Deserve the Real Ones? New York Times reported:
“But on Wednesday, 18 leading vaccine experts — including a top regulator at the Food and Drug Administration — argued that vaccinating placebo groups early would be disastrous for the integrity of the trials. If all of the volunteers who received placebo shots were to suddenly get vaccinated, scientists would no longer be able to compare the health of those who were vaccinated with those who were not.
“‘If you’re going to prioritize people to get vaccinated, the last people you should vaccinate are those who were in a placebo group in a trial,’ said Richard Peto, a medical statistician at the University of Oxford. Mr. Peto and his colleagues laid out their concerns in a new commentary in The New England Journal of Medicine.”
IBM Uncovers Global Email Attack on COVID Vaccine Supply Chain. CNBC reported:
“‘We assess that the purpose of this campaign may have been to harvest credentials to gain future unauthorized access,’ IBM researchers Claire Zaboeva and Melissa Frydrych wrote in a report. ‘From there, the adversary could gain insight into internal communications, as well as the process, methods and plans to distribute a COVID-19 vaccine.’
“IBM said the attacks likely targeted organizations linked to Gavi, The Vaccine Alliance, which is working to supply low- and middle-income economies with an affordable coronavirus vaccine. The alliance, which is backed by the Bill & Melinda Gates Foundation, operates a program alongside UNICEF to strengthen immunization supply chains to ensure the drugs are distributed equitably.”
China Has Promised Millions of Coronavirus Vaccines to Countries Globally. And It Is Ready to Deliver Them. CNN reported:
“China currently has five coronavirus candidates from four companies which have reached phase 3 clinical trials, the last and most important step of testing before regulatory approval is sought.
“Having largely eliminated the coronavirus inside its borders, Chinese drugmakers had to look abroad for places to test the efficacy of their vaccines. Together, they have rolled out phase 3 trials in at least 16 countries.”
December 2, 2020
UK Authorizes Pfizer Coronavirus Vaccine for Emergency Use. Associated Press reported:
“The go-ahead for the vaccine developed by American drugmaker Pfizer and Germany’s BioNTech comes as the virus surges again in the United States and Europe, putting pressure on hospitals and morgues in some places and forcing new rounds of restrictions that have devastated economies.
“The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95% effective overall — and that it also offered significant protection for older people, among those most at risk of dying from the disease. But the vaccine remains experimental while final testing is done.”
Healthcare Workers and Nursing Home Residents Should Be First to Get Coronavirus Vaccines, CDC Advisory Group Says. Washington Post reported:
“The first doses of a coronavirus vaccine should be given to an estimated 21 million health-care workers and three million residents and staff of nursing homes and other long-term care facilities, a federal advisory panel recommended Tuesday afternoon.
“These groups were deemed the highest priority by the Advisory Committee on Immunization Practices, because the vaccine will initially be in extremely short supply after it is cleared by federal regulators. Health-care personnel are a top priority because of their exposure to the virus and their critical role keeping the nation’s hospitals and clinics functioning.”
COVID-19 Vaccines Face a Varied and Powerful Misinformation Movement Online. NBC News reported:
The side effects, which come from the vaccine shots, can last up to a day and a half, said Dr. Moncef Slaoui, who is leading the Trump administration’s COVID-19 vaccine program Operation Warp Speed. The people who’ve suffered from side effects have reported redness and pain at the injection site as well as fever, chills, muscle aches and headaches, he said, adding most people have no noticeable side effects.
“‘The longer, more important kind of adverse events such as some autoimmune disease or others have not been reported in a different way between the placebo group and the vaccine group in these two trials, which is very reassuring,’” he told The Washington Post. “‘I always make sure we say that [while] we know the short term and I’m going to call it midterm effects of the vaccine is now well understood, the very long-term safety is not yet understood by definition.’”
Trump COVID Vaccine Czar Says Side Effects ‘Significantly Noticeable’ in 10% to 15% of Recipients. CNBC reported:
The side effects, which come from the vaccine shots, can last up to a day and a half, said Dr. Moncef Slaoui, who is leading the Trump administration’s COVID-19 vaccine program Operation Warp Speed. The people who’ve suffered from side effects have reported redness and pain at the injection site as well as fever, chills, muscle aches and headaches, he said, adding most people have no noticeable side effects.”
The Cold Rush: Pfizer’s COVID Vaccine Jump-Starts Race for Special Freezers. Washington Post reported:
“Before the pandemic, ultracold freezers were a relatively niche market, supplying pharmaceutical companies, hospital labs and universities with the specialized and prohibitively costly cooling units.
“Now, with the challenge of international vaccine distribution looming, ULT freezers are becoming much sought after, much like personal protective equipment and ventilators in the early months of the pandemic.
“Ford has announced it is acquiring its own ultracold freezers to supply employees with Pfizer’s vaccine. Hospital systems, logistics and delivery companies are also gearing up.”
December 1, 2020
Fauci Asks Americans to Prepare to Get Vaccinated as States Plan for Distribution. CNN reported:
As the U.S. prepares for the first round of vaccinations to tackle COVID-19, infectious disease expert Dr. Anthony Fauci called on the public to ‘be part of the solution’ and get vaccinated once it is available.
“’Say, ‘I’m not going to be one of the people that’s going to be a steppingstone for the virus to go to somebody else. I’m going to be a dead end to the virus,’ Fauci told Facebook CEO Mark Zuckerberg Monday.”
Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine. New York Times reported:
“Mr. Bancel said the company was ‘on track’ to produce 20 million doses by the end of December, and 500 million to a billion in 2021. Each person requires two doses, administered a month apart, so 20 million doses will be enough for 10 million people.
“Moderna is the second vaccine maker to apply for emergency use authorization; Pfizer submitted its application on Nov. 20. Pfizer has said it can produce up to 50 million doses this year, with about half going to the United States. Its vaccine also requires two doses per person.”
CDC Panel Set to Vote Tuesday on Who Gets Coronavirus Vaccine First. NBC News reported:
“The meeting with the Advisory Committee on Immunization Practices, or ACIP, an outside group of medical experts that advises the CDC, comes a day after Moderna requested emergency clearance from the U.S. Food and Drug Administration for its COVID-19 vaccine. Pfizer, which is working with German drugmaker BioNtech, applied for the same authorization on Nov. 20. U.S. officials expect the first doses of one of the vaccines could be distributed in a few weeks — even before the end of the year.”
GM Preps to Unveil Plan to Workers Around COVID-19 Vaccine Distribution. Detroit Free Press reported:
“General Motors is preparing a plan for the arrival of COVID-19 vaccines that it will likely unveil to workers this month.
“GM has been talking with local health department and government leaders to coordinate who will be leading and conducting vaccine distribution, GM spokesman David Caldwell told the Free Press Monday.”
Serum Institute’s COVID-19 Vaccine Triggers ‘Behavioural Change’ in Participant; Drug Regulator Silent. National Herald reported:
“A 40-year-old man who volunteered for ‘Covishield’, the vaccine being tested by Pune-based Serum Institute of India (SII), has sued the company for Rs 5 crore. He stated that the vaccine triggered an adverse reaction, including memory loss and an inability to get back to life before being administered the vaccine. SII has partnered with AstraZeneca and Oxford University for producing the vaccine in India.”
Oxford Controversy Is the First Shot in International Battle Over Vaccine Efficacy. Guardian reported:
“In a few days, researchers plan to solve a medical mystery that threatens to erupt into a major transatlantic battle. Scientists at Oxford University say they intend to publish full, peer-reviewed data, in the journal Lancet, about trials they have completed on their COVID-19 vaccine.
The information, they say, should end mounting controversy about the vaccine’s effectiveness and explain apparent inconsistencies in trial results. Opponents, most of them American, say this is unlikely, and insist new phase 3 trials now need to be restarted from scratch to restore confidence in the vaccine.”
Some Health are Workers Are Wary of Getting COVID-19 Vaccines. NPR reported:
“But the speed of COVID-19 vaccine development, along with concerns about political interference with the process, has left some health care workers on the fence about COVID-19 vaccines.”
November 27, 2020
As COVID-19 Vaccine Nears, Employers Consider Making It Mandatory. NPR reported:
The U.S. Occupational Safety and Health Administration has stated that employers can legally impose a flu vaccine requirement on their workforce, but employees have the right to request medical or religious exemptions under federal anti-discrimination laws. Each claim must be evaluated on its own merits, a time-consuming process for employers.
“While it may be legal for employers to compel their workers to get the COVID-19 vaccine, doing so would be a huge, difficult undertaking, says Y. Tony Yang, executive director of the Center for Health Policy and Media Engagement at George Washington University, who has argued against COVID-19 vaccine mandates.”
The Virus Won’t Stop Evolving When the Vaccine Arrives. New York Times reported:
“But vaccines won’t put an end to the evolution of this coronavirus, as David A. Kennedy and Andrew F. Read of The Pennsylvania State University, specialists in viral resistance to vaccines, wrote in PLoS Biology recently. Instead, they could even drive new evolutionary change.
“There is always the chance, though small, the authors write, that the virus could evolve resistance to a vaccine, what researchers call “viral escape.” They urge monitoring of vaccine effects and viral response, just in case.”
Americans should be warned of coronavirus vaccine side effects, medical experts say. Fox News reported:
“Meanwhile, during the online meeting with the Advisory Committee on Immunization Practices, Patsy Stinchfield, a nurse practitioner at Children’s Minnesota, suggested that public health officials change the language used when warning the public about side effects. She recommended using the word “response” rather than ‘adverse reaction,’ per CNBC.
“‘These are immune responses,’ said Stinchfield. ‘And so if you feel something after vaccination, you should expect to feel that. When you do, it’s normal to have some arm soreness or fatigue, some body aches and maybe even a fever. It sounds like in some of these trials, maybe even having to stay home from work.’”
After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine. New York Times reported:
“But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.
“Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results.”
The AstraZeneca Covid Vaccine Data Isn’t Up to Snuff. Wired reported:
“Monday’s press release from AstraZeneca presents “convincing evidence that [the vaccine] works,” said Science. But not everyone has been convinced. The price of AstraZeneca’s shares actually dropped on the news, and an analysis from an investment bank concluded, ‘We believe that this product will never be licensed in the US.’ Over at STAT News, Anthony Fauci cautioned that we’ll need to see more data before coming to a conclusion. The skeptics have strong reasons to be concerned: This week’s ‘promising’ results are nothing like the others that we’ve been hearing about in November — and the claims that have been drawn from them are based on very shaky science.”
The Healthcare System Has Failed Black Americans. No Wonder Many Are Hesitant About a Vaccine. Washington Post reported:
“But I have heard from Black friends and family members who say they don’t want to take a coronavirus vaccine. Some have misgivings about whether a vaccine produced so fast would be safe; others say they don’t trust pharmaceutical companies to be transparent about risks. They aren’t alone. A September survey by the nonprofit COVID Collaborative found that fewer than half of Black people said they would definitely or probably take a vaccine made available at no charge. Just 14 percent said they trusted it would be safe. A Pew Research Center poll, also from September, illuminated the stark difference in attitudes by race: It found that 32 percent of Black adults would definitely or probably take a vaccine when available, compared with 52 percent of Whites and 56 percent of Hispanics.”
Poll: Many People Insist They Will Not Get a COVID-19 Vaccine. Komo News reported:
“[Bernadette] Pajer is the public policy director for Informed Choice Washington — an organization that doesn’t identify as anti-vaccine, but says they believe in healthy immunity and personal freedoms.
While doctors strongly disagree, Pajer says that getting a vaccine for coronavirus is unnecessary and possibly dangerous.
“’We do not know the long-term health impacts of this vaccine,’” said Pajer.
In China, Nearly 1 Million People Have Reportedly Already Gotten a Coronavirus Vaccine. Vox reported:
The vaccinations have occurred as part of an emergency use program that began in late July, though few details about it have been revealed by the Chinese government. What we do know is that as part of the program, China’s State Council authorized high-risk groups including medical workers, customs officials, and transportation workers to start receiving one of three Chinese-made vaccines — two from Sinopharm and one produced by Sinovac. But some Chinese cities have also been offering the vaccines to members of the public.”
Feds on COVID-19 mRNA Vaccine Distribution: Pfizer’s Dry Runs Predict a ‘Very Doable Process.’ Fierce Pharma reported:
Alex Azar, secretary of health and human services, acknowledged during a press conference Tuesday that the logistics — which include the need for ultra-cold storage — will be far from easy. But Azar and two other top officials running the government’s Operation Warp Speed effort to speed COVID-19 vaccine distribution did their best to boost the public’s confidence.”
Iowa State Taps Device Maker Zeteo for Early Work on Nasal Spray COVID-19 Vaccine. Fierce Pharma reported:
“The Nanovaccine Institute at Iowa State University says it’s developing a next-generation nanovaccine against SARS-CoV-2, the virus that causes COVID-19, and it recently tapped drug delivery specialist Zeteo Biomedical to lend its device and technical support, the partners announced separately.“Nanovaccines like Iowa State’s work by loading viral proteins into nanoparticles, about 300 billionths of a meter across, made from biodegradable polymers, the institute said in a release. Crucially, Iowa State’s candidate will be formulated as a single-dose nasal spray, deliverable by way of a solitary sniff.”
November 24, 2020
More Than Two-Thirds of Americans Oppose Mandatory COVID-19 Vaccinations. ZeroHedge reported:
“Opinion polling is clear: In the US, more than two thirds of the population feels receiving a COVID-19 vaccine should be voluntary. What’s more, only a small percentage of Americans would push to be vaccinated within the first month of a vaccine being widely available. Most appear content to hang back, presumably more concerned about when the economy will be allowed to reopen than when they might be able to get vaccinated.”
Doctors Say CDC Should Warn People the Side Effects From COVID vaccine Shots Won’t Be ‘a Walk in the Park.’ CNBC reported:
“Public health officials and drugmakers must be transparent about the side effects people may experience after getting their first shot of a coronavirus vaccine, doctors urged during a meeting Monday with CDC advisors as states prepare to distribute doses as early as next month.
“Dr. Sandra Fryhofer of the American Medical Association noted that both Pfizer’s and Moderna’s COVID-19 vaccines require two doses at varying intervals. As a practicing physician, she said she worries whether her patients will come back for a second dose because of the potentially unpleasant side effects they may experience after the first shot.”
Teenagers Are Latest participants in COVID-19 Vaccine Trials; Safety Concerns Arise. Fox Business reported:
“Around 400 children, ages 16 and 17, have enrolled in the study, which administers two doses of Pfizer’s experimental vaccine, in addition to about 100 children in the 12 to 15 age group. After the safety review confirms that testing can continue, the clinic will aim to enroll up to 2,600 between the ages of 12 to 18 nationwide.”
Moderna Boss Says COVID-19 Vaccine Not Proven to Stop Spread of Virus. New York Post reported:
“Moderna’s coronavirus vaccine may not get life back to normal right away because it hasn’t yet been proven to prevent the deadly bug from spreading, the company’s top doctor says.
“Research has shown that the biotech firm’s shot is effective at preventing people from getting sick with COVID-19, but there’s no hard evidence that it stops them from carrying the virus ‘transiently’ and potentially infecting others who haven’t been vaccinated, according to Dr. Tal Zaks, Moderna’s chief medical officer.”
Experts Have Questions About AstraZeneca’s Vaccine Data. CNN reported:
“Vaccine experts — including those who serve on advisory committees for the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention — have questions about data released Monday by AstraZeneca about its COVID-19 vaccine.”
“In a press release Monday, the pharmaceutical giant announced that its vaccine is on average 70% effective. However, the company did not state the data that led them to that conclusion.”
Coronavirus Vaccines Face Trust Gap in Black and Latino Communities, Study Finds. Washington Post reported:
“If offered a coronavirus vaccine free of charge, fewer than half of Black people and 66 percent of Latino people said they would definitely or probably take it, according to a survey-based study that underscores the challenge of getting vaccines to communities hit hard by the pandemic.
“The survey released Monday is one of the largest and most rigorous to date. Other recent studies have also pointed to vaccine hesitancy in communities of color, but Monday’s survey delved deeper into the reasons, polling respondents on a spectrum of questions to get at the roots of their distrust.”
Doctors and Nurses Want More Data Before Championing Vaccines to End the Pandemic. Washington Post reported:
“Medical experts said attitudes among doctors, nurses and the public could shift quickly as new data are revealed. But government, academic, and health-care officials say that significant numbers of providers want more data about the vaccine before it is deployed. Some of the information is expected to be released next month by the FDA.”
“A report released Thursday by the University of California at Los Angeles researchers said that 66 percent of Los Angeles health-care workers who responded to an online questionnaire (not a randomized sample) said they would delay taking a vaccine. The American Nurses Association, a national union, said one-third of its members do not intend to take the vaccine, and an additional third are undecided.”
Tennessee Bill Would Expand Coronavirus Vaccine Exemptions. WATE.com reported:
“Tennessee would no longer prohibit parents from refusing vaccinations of their children under a newly filed proposal as COVID-19 cases continue to rise.
“Tennessee law currently allows parents to cite several exemptions to not immunize their children as long as the state isn’t in an epidemic.”
Bill Gates Says AstraZeneca, Johnson & Johnson, Novavax COVID-19 Vaccines All Likely To Prove ‘Very Efficacious And Safe’ By February. Yahoo Finance reported:
“‘I’m optimistic that by February, it’s very likely they’ll all prove very efficacious and safe,’ said Gates.
AstraZeneca Vaccine Up to 90% Effective and Easily Transportable, Says Company. Washington Post reported:
“The Oxford-AstraZeneca vaccine is likely to be cheaper than those made by Pfizer and Moderna, and it does not need to be stored at subzero temperatures but can be kept in ordinary refrigerators in pharmacies and doctor’s offices.
AstraZeneca executives said the vaccine is already being manufactured. The first 4 million doses could be ready in December, and 40 million could be delivered in the first quarter of 2021, they said. By the spring, the company and its global partners in India, Brazil, Russia and the United States could be cranking out 100 million to 200 million doses a month.”
Pfizer Aims to Ship COVID-19 Vaccine Doses ‘Within Hours’ of Regulatory Nods, CEO Says. Will a ‘Race to Regulate’ Ensue? Fierce Pharma reported:
“This week, the FDA official in charge of overseeing the vaccine review process said the agency’s detailed look at the data will take weeks, not days. High-priority vaccinations could begin in the U.S. next month, with everyday Americans getting vaccines as soon as April, U.S. health officials said this week.
“Pfizer has already made 20 million doses and plans to produce around 50 million by the end of 2020. The company has a much more ambitious goal of 1.3 billion doses for 2021.”
November 20, 2020
2 Companies Say Their Vaccines Are 95% Effective. What Does That Mean? New York Times reported:
“From the headlines, you might well assume that these vaccines — which some people may receive in a matter of weeks — will protect 95 out of 100 people who get them. But that’s not actually what the trials have shown. Exactly how the vaccines perform out in the real world will depend on a lot of factors we just don’t have answers to yet — such as whether vaccinated people can get asymptomatic infections and how many people will get vaccinated.”
Over Half of Adults Over 50 Say They’ll Get Vaccinated Against COVID-19, But Many Will Want to Wait, Poll Finds. Newswise reported:
“In all, 58% of adults aged 50 to 80 say they are somewhat or very likely to get vaccinated to prevent COVID-19, according to new results from the National Poll on Healthy Aging from the University of Michigan.
That number went up to 66% when the poll team asked the question a different way: 20% said they’d want to get vaccinated right away when vaccines become available, but 46% said they’d rather wait for others to get vaccinated first before doing it themselves.”
Pfizer and BioNTech to Request Emergency Authorization From FDA for COVID vaccine. CNBC reported:
“If Pfizer’s application is approved, the vaccine will likely be limited and rolled out in phases, with health-care workers, the elderly and people with underlying health conditions getting the first inoculations. Essential workers, teachers and people in homeless shelters and prisons would likely be next, followed by children and young adults.
“The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine has been tentatively scheduled for early December. Some Americans could get their first dose of the vaccine in about a month.”
Doing the Touchy Math on Who Should Get a COVID Vaccine First. Scientific American reported:
“‘But figuring out how to allocate vaccines — there are close to 50 in clinical trials on human — to the right groups at the right time is “a very complex problem,’ says Eva Lee, director of the Center for Operations Research in Medicine and Health Care at the Georgia Institute of Technology. Lee has modeled dispensing strategies for vaccines and medical supplies for Zika, Ebola, and influenza, and is now working on COVID-19. The coronavirus is ‘so infectious and so much more deadly than influenza,’ she says. ‘We have never been challenged like that by a virus.’”
When Will COVID-19 Vaccines Be Widely Available? Feds Lay out Ambitious Timeline. Fierce Pharma reported:
“High-priority populations such as healthcare workers and nursing home residents could obtain COVID-19 vaccines in December, Department of Health and Human Services Secretary Alex Azar said in a press conference. Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, predicted in a meeting with USA Today’s editorial board that everyday Americans could be vaccinated as early as April.”
COVID-19 Vaccines: No TIme for Complacency: The Lancet reported:
“Unfortunately, the trials’ results were announced via press releases, leaving many scientific uncertainties that will dictate how the vaccines will affect the course of the pandemic. Little safety data are available. How well the vaccines work in older people or those with underlying conditions and their efficacy in preventing severe disease are still unclear. Peer-reviewed publication should resolve these issues, but other questions will not be answerable for some time. For one, the duration of protection is unknown and will have a huge bearing on the practicalities and logistics of immunisation (will boosters be needed? How often?).”
November 19, 2020
America’s Doctors Say COVID-19 Vaccine Trials Must Start Including Kids — Now. Huffington Post reported:
“‘We eagerly anticipate seeing the safety and efficacy data in vaccine trials that are underway in adults, and urge pharmaceutical companies to rapidly expand their participant panels to include children and adolescents,’” Dr. Yvonne Maldonado, chair of the [American Academy of Pediatrics] Committee on Infectious Diseases, said in a press statement.
Once Approved, First COVID-19 Vaccine Doses Will Go Out in 24 Hours, Official Says. Spectrum News reported:
“‘We will begin distribution of the vaccine within 24 hours after Emergency Use Authorization is approved,’ Army Gen. Gustave Perna, who is leading Operation Warp Speed, said in a media briefing Wednesday. ‘Then we will begin a weekly cadence of delivery of [the] vaccine.’”
As Vaccine Approvals Loom, U.S. Funds A Back-Up Plan For Delivery. NPR reported:
“As the nation gears up for a massive vaccination effort, the Trump administration is doubling down on a novel, unproven injection device by providing more than half a billion dollars in government financing for something that is still awaiting Food and Drug Administration approval.”
Oxford-AstraZeneca COVID Vaccine Shows Robust Immune Response Among Older Adults. CNBC reported:
“The study of 560 healthy adults, including 240 over age 70, found the vaccine to be safe and produced a similar immune response among people age over 56 and those ages 18 to 55.
“Older people face a “significant risk” of developing severe illness on contracting COVID-19, the WHO has said, citing decreased immune function and potential underlying health conditions. People of all ages are at risk of contracting the virus, however.”
Pfizer Declares Its Vaccine is 95% Effective. Bloomberg reported:
“Pfizer said a final analysis of its clinical-trial data showed its COVID-19 vaccine, developed with the help of the German government and Germany-based BioNTech, was 95% effective, which may pave the way for the company to obtain regulatory authorizations for its use. Scientists however are calling for the release of more data on the new medicine — which faces huge logistical hurdles when it comes to distribution — so it can be independently reviewed and analyzed. Rivals including Moderna, meanwhile, are close behind with their own drugs, which may be easier to ship. The Pfizer statement comes a week after the pharmaceutical giant said it had positive preliminary information on the potential vaccine. At the time, the company’s stock soared, and Chief Executive Officer Albert Bourla made $5.6 million selling his shares.”
Fauci Says the Average American Could Get Vaccinated Against COVID-19 as Soon as April: ‘I Would Take the Vaccine.’ USA Today reported:
“If most of the population is vaccinated by summer and fall, Fauci said, people can start looking forward to returning to pre-pandemic normalcy.
“‘Then you can start talking about this umbrella or blanket of protection on society that would diminish dramatically the risk of a person being exposed or even being infected,’ he said. ‘When so many people are protected, that’s when you get into the real herd immunity.’”
Trump Officials See Surge in Sign-Ups for Free CVS, Walgreens COVID Vaccine Program for Seniors. CNBC reported:
“The Trump administration said Wednesday that it is seeing ‘tremendous uptake’ of a program that will allow CVS Health and Walgreens to administer coronavirus vaccines to seniors in long-term care facilities.
“Health and Human Services Secretary Alex Azar said that 99% of skilled nursing facilities across the country have signed up for the program, which will give COVID-19 vaccines to seniors free of charge and will be available to residents in all long-term care settings, including skilled nursing facilities, assisted living facilities, residential care homes and adult family homes. He said 100% of facilities in 20 states are signed up.”
Johnson & Johnson Expects Coronavirus Vaccine to Be Ready for Approval by February, Report Says. Fox News reported:
“Johnson & Johnson’s lead scientist said the company expects to have all data needed to file for authorization for its single-shot coronavirus vaccine candidate by February, according to a report.
“Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer, reportedly told Reuters that the company expects to have 60,000 people enrolled in a late-stage trial, dubbed ENSEMBLE, by year’s end.”
Inside Mexico’s Quest for a Homemade Vaccine. CNN reported:
“These are the trial runs of a COVID-19 vaccine production line in Mexico City, to which CNN was recently given exclusive access. The ampoules we saw were only filled with water. But if all goes to plan, officials hope to be producing millions of vaccine doses this way by the end of 2021.
“For Mexico, the development of its own vaccine is not just a matter of public health. While the first vaccines will be produced much earlier by some of the world’s richest countries, a nationally produced vaccine is Mexico’s failsafe — its best bet to ensure that if vaccine supplies from other countries prove difficult to obtain, its roughly 130 million citizens will still be protected.”
Nearly 1 Million Chinese People Have Received Drug Maker’s COVID-19 Vaccines. Wall Street Journal reported:
“Chinese authorities have inoculated nearly one million Chinese people with a COVID-19 vaccine from Sinopharm, though the state company has yet to provide solid clinical evidence of efficacy.”
COVID Vaccines Must Be ‘a Global, Public Good,’ WHO Says. CNBC reported:
“‘In the last few days we have received good news with two particularly promising vaccines. However, this promise will never be realized unless we ensure that all countries have access to the vaccine market, that it is delivered equitably, that it is effectively deployed and that countries address pockets of vaccine hesitancy,’ said Dr. Hans Kluge, WHO regional director for Europe.”
November 18, 2020
Food Stamps, Rent Assistance May Be Withheld From Those Who Refuse COVID-19 Vaccinations. Sandra Rose reported:
“Americans who refuse to get mandated COVID-19 vaccinations may lose benefits such as food stamps (WIC) and rent assistance, according to a document from Johns Hopkins Bloomberg School of Public Health’s Center for Health Security.
“According to the document, one of the top members of the “Working Group of Readying Populations for COVID-19 Vaccines” is Luciana Borio, MD, a prominent member of Joe Biden’s COVID-19 taskforce.”
Fauci Says 20 Million Americans Could Get Vaccinations Around the End of the Year. The Boston Globe reported:
“Dr. Anthony Fauci, the nation’s top infectious disease expert, said Tuesday that as many as 20 million people could get coronavirus vaccinations around the end of the year.
He said by that time there could be as many as 25 million doses of vaccine available from Pfizer and 15 million doses available from Moderna. The vaccination takes two shots so that would mean 20 million people could get protection.”
Pfizer’s COVID-19 Vaccine Just Came a Little Closer to Emergency Approval. Vox reported:
“But there are concerns as well. Pfizer and BioNTech’s latest announcement came, for the second time, in a press release instead of a peer-reviewed paper, although the companies revealed far more about the demographics of their clinical trial than in their first report. BNT162b2 also has some of the most stringent cold storage requirements, demanding temperatures of -70 degrees Celsius (-94 degrees Fahrenheit) or lower, which may make widespread distribution challenging. The vaccine is also administered in two doses spaced several weeks apart. That adds a huge logistical burden to rolling out the vaccine.”
Israel Health Ministry May Recommend Mandatory Coronavirus Vaccine Law. The Jerusalem Post reported:
“The move is meant to overcome hesitations by parts of the public against vaccinating. Many Israelis may not want to take the vaccination when it is first released.
“The team has expressed concerns in the past about Israelis not being willing to vaccinate and has recommended a number of steps, including increasing public education on the matter.”
Coronavirus Vaccine Shots Could Go to U.S. Health Workers in About a Month. CNBC reported:
“Health and Human Services Secretary Alex Azar told CNBC earlier this week that the FDA would move ‘as quickly as possible’ to clear both Pfizer and Moderna’s vaccine. The FDA process is expected to take a few weeks, and an advisory committee meeting to review the vaccine has been tentatively scheduled for early December.
“‘We will independently call those balls and strikes on the data and evidence, but we’re going to do so as quickly as possible, consistent with just making sure the science, the evidence and the law support authorization,’ Azar told CNBC’s “Squawk Box” on Monday.”
CureVac Deal Takes EU’s COVID Vaccine Supplies Close to Two Billion. Reuters reported:
“The European Union has struck a deal for up 405 million doses of German biotech firm CureVac’s 5CV.DE potential COVID-19 vaccine, the head of the EU executive said on Monday, taking total supplies secured by the bloc to nearly 2 billion doses.
“The deal with CureVac follows EU supply agreements with AstraZeneca AZN.L, Johnson & Johnson JNJ.N, Sanofi SASY.PA, and Pfizer PFE.N for a combined 1.4 billion doses of their potential vaccines.”
November 17, 2020
Forced Vaccination Law in Denmark Abandoned After Public Protests. Summit News reported:
“Last week we highlighted how both Ticketmaster and airline companies are considering barring people from entering venues and flying if they cannot prove they have taken the vaccine.
“So while public protests may be able to prevent authorities carrying out forced vaccinations, people who refuse to take the shot may find it virtually impossible to enjoy any kind of social life, use public transport, or even find employment.”
How a COVID-19 Vaccine Could End Up Helping the Virus Spread. Bloomberg reported:
“It’s also not yet clear how much protection the Pfizer-BioNTech vaccine and others would provide. The gold standard is to achieve sterilizing immunity, which is so strong that the virus can’t get a grip in the body at all — meaning that vaccinated people are safe to others. The human papillomavirus vaccine provides sterilizing immunity, for example. But sterilizing immunity is hard to achieve with viruses such as SARS-CoV-2, which enter through the respiratory system. The only sure way to know if the vaccine provides sterilizing immunity would be to check whether trial subjects who remain free of Covid-19 have been exposed to it, by tracing their contacts.”
Pfizer to Start Pilot Delivery Program for Its COVID-19 Vaccine in Four States. Fox Business reported:
“‘We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,’ Pfizer said in a statement on Monday.
“It picked Rhode Island, Texas, New Mexico, and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunization infrastructure, and need to reach individuals in varied urban and rural settings.”
Pfizer’s COVID-19 Vaccine Distribution Will Be a ‘Logistical Nightmare.’ CBS News reported:
“Pfizer declined to offer specifics about the plan to distribute its vaccine. While the government is technically in charge of the overall vaccination effort, the company has opted to distribute its own vaccine. Pfizer has received $1.95 billion from the Operation Warp Speed to manufacture and distribute the first 100 million doses. The government will remain responsible for distributing syringes and other medical supplies needed for the vaccination effort.”
Novavax Posts Coronavirus Vaccine Contract That Government Didn’t Disclose. NPR reported:
“Notably, the Department of Health and Human Services told NPR in late August that it had “no records” of the Novavax contract in response to a public records request for it over the summer. The agency announced the deal July 7 to support development, manufacturing and the purchase of 100 million doses.
“Novavax released its federal contract in a quarterly financial filing with the Securities and Exchange Commission. HHS has yet to release this contract.”
It’s the ‘Vaccine Hesitant,’ Not Anti-Vaxxers, Who Are Troubling Public Health Experts. The Guardian reported:
“Only 7% would definitely refuse a COVID vaccine, according to a poll published last week by JL Partners. But around one in five are reluctant to some degree, with women more likely than men to believe it hasn’t been tested thoroughly enough. It’s these wobbling ‘vaccine hesitants’ who could most easily be swayed by something their friend puts on Facebook; who’d rather wait and see what happens when others have the jab.”
Encouraging Data From COVID-19 Vaccines Won’t Prevent a Dangerous Stretch of Rising Cases, Experts Warn. CNN reported:
“While the high efficacy rates coming out of the Moderna and the Pfizer/BioNTech vaccine trials are a good first step, a vaccine has yet to be approved and experts will also have to decide which groups should get vaccinated first.
An advisory committee to the U.S. Centers for Disease Control and Prevention is scheduled to meet next week to decided who will get the vaccine first, a longtime member of the committee said.”
COVID: Chemicals Found in Everyday Products Could Hinder Vaccine. The Guardian reported:
“Small amounts of per- and polyfluoroalkyl (or PFAS) chemicals are commonly found in the bodies of people in the U.S., as well as several other countries. These man-made chemicals, used in everything from non-stick pans to waterproof clothes to pizza boxes, have been linked to an elevated risk of liver damage, decreased fertility and even cancer.
“But scientists warn some of these chemicals can also cause another little-known but potentially significant defect by reducing the effectiveness of certain administered vaccines. This impediment could cast a shadow over efforts to roll out a COVID-19 vaccine to enough people that restrictions on day-to-day life are eased.”
What Does COVID-19 Vaccine Effectiveness Mean? Associated Press News reported:
“For both vaccines, the interim results were based on people who had COVID-19 symptoms that prompted a virus test. That means we don’t know yet whether someone who’s vaccinated might still get infected — even if they show no symptoms — and spread the virus.
“Also unknown is whether the shots will give lasting protection, or whether boosters will be required.”
Could mRNA COVID-19 Vaccines Be Dangerous in the Long-Term? The Jerusalem Post reported:
“An article published by the National Center for Biotechnology Information, a division of the National Institutes of Health, said other risks include the bio-distribution and persistence of the induced immunogen expression; possible development of auto-reactive antibodies; and toxic effects of any non-native nucleotides and delivery system components.”
November 13, 2020
States Ramping Up for Biggest Vaccination Effort in U.S. History. Associated Press reported:
“The push could begin as early as next month, when federal officials say the first vaccine may be authorized for emergency use and immediately deployed to high-risk groups, such as health care workers.
“‘The calvary is coming,’ Dr. Anthony Fauci said Thursday on ABC’s ‘Good Morning America.” He said he hopes shots will be available to all Americans in April, May and June.”
Bill And Melinda Gates Are Giving Another $70 Million For Covid Vaccines. Forbes reported:
“Of the newly promised $70 million, $50 million will go to the Covax Advance Market Committee of Gavi, the Vaccine Alliance; the committee is a financing mechanism through which Gavi works to secure equitable access to COVID-19 vaccines for 92 low- and middle-income countries. The donation will unlock an additional $16 million from the U.K. government, part of a commitment the country made to match some donations to the committee.”
HHS announces COVID-19 vaccine agreement with drug stores. Modern Healthcare reported:
“The goal eventually is to make getting a COVID-19 vaccine like getting a flu shot.
“Thursday’s agreement with major chain drug stores, grocery market pharmacies and other chains and networks covers about 3 in 5 pharmacies in all 50 states and U.S. territories such as Puerto Rico. It looks ahead to a time next spring when yet-to-be-approved vaccines will start to become available beyond priority groups such as health care workers and nursing home residents.”