Sen. Ron Johnson: There Is Not an FDA-Approved COVID Vaccine in the U.S. + More

Sen. Ron Johnson: There Is Not an FDA-Approved COVID Vaccine in the U.S.

Fox News reported:

Senator Ron Johnson, R-Wisc., claimed that the U.S. still doesn’t have an FDA-approved vaccine as he exposed what was really approved by the government agency on “Fox News Primetime.”

“We do not have an FDA-approved vaccine being administered in the U.S. The FDA played a bait and switch. They approved the Comirnaty version of Pfizer drugs. It’s not available in the U.S. They even admit it. I sent them a letter three days later going ‘What are you doing?’ What they did is they extended the emergency use authorization for the Pfizer drug vaccine that’s available in the U.S., here that’s more than 30 days later, they haven’t asked that very simple question.”

As Obesity Takes a Greater Toll in COVID Deaths, Health Officials Are Quiet

WFAE reported:

The children with COVID-19 in Dr. Eugene Daugherty’s pediatric intensive care unit often have one thing in common: obesity.

“At least 9 out of 10 patients that we’re seeing who are sick enough especially to be in the ICUs throughout the state, obesity plays a part in this,” said Daugherty, who is with Novant Health’s Children’s Hospital in Charlotte.

Since the start of the pandemic, there have been numerous studies worldwide showing the heightened dangers that COVID-19 poses to people who are overweight. The World Obesity Federation, for instance, has shown that death rates from COVID-19 have been 10 times higher in countries where more than half of the population is overweight.

Fauci Says It’s ‘Too Soon to Tell’ Whether Americans Should Avoid Gathering for Christmas

CBS News reported:

Dr. Anthony Fauci, chief medical adviser to President Biden, said Sunday it’s too early to say whether Americans should avoid larger family gatherings for Christmas, while the nation experiences an uptick in new COVID-19 infections among children alongside lagging vaccination rates.

In an interview with “Face the Nation,” Fauci said it’s “just too soon to tell” whether holiday gatherings should be limited for the second year in a row due to the ongoing pandemic, but said Americans need to focus on lowering the number of new infections and hospitalizations.

COVID Antiviral Pill Could Be a Game Changer, but Vaccines Are Still America’s Way Out of the Pandemic, Experts Say

CNN Health reported:

A pill that could potentially treat COVID-19 is a “game-changer,” but experts are emphasizing that it’s not an alternative to vaccinations — which remain the most effective path to ending the coronavirus pandemic if enough people get their shots.

The news from Merck and Ridgeback Biotherapeutics on Friday that they created an antiviral pill that can reduce COVID-19 hospitalization and death by 50% was hailed by health experts, although they cautioned it wasn’t a replacement for vaccinations.

“This can be used in conjunction with the vaccine. And it’s not an alternative to vaccination. We still have to try to get more people vaccinated,” Dr. Scott Gottlieb, former commissioner of the U.S. Food and Drug Administration, told CNN on Friday.

Researchers Developing Patch to Replace Painful Vaccine Shots

CBS Miami reported:

Researchers at the University of North Carolina at Chapel Hill are developing a new technology that could make getting the COVID-19 vaccine, flu shots, and childhood vaccines pain-free and without needles. According to the CDC, as many as 25% of adults and many children have a fear of needles, some so severe it prevents them from getting vaccinated.

Dr. Joseph DeSimone at Stanford University is working with researchers at UNC on a tiny patch that can deliver vaccines when applied to the skin. “And so, our approach was to directly 3D-print the microneedles and use a breakthrough in 3-D printing that we pioneered,” he said.

J&J to Ask FDA to Approve Its COVID Booster Shot

HealthDay News reported:

Johnson & Johnson plans to ask the U.S. Food and Drug Administration to approve emergency use of a booster shot of its single-dose COVID-19 vaccine early this week.

While the request has yet to be submitted, the FDA on Friday scheduled an Oct. 15 meeting of its expert advisory panel to discuss whether a booster shot of the vaccine should receive emergency use authorization, The New York Times reported.

The scheduling of that meeting before Johnson & Johnson has even filed its application with the FDA highlights the Biden administration‘s concerns that the 15 million Americans who received the company’s vaccine require more protection, the Times said.

Italian Studies Show COVID Shots Less Effective in Immunocompromised

Reuters reported:

COVID-19 vaccines are less effective on people with weakened immune systems, three small Italian studies show, which the studies’ researchers say highlight the need to deploy booster shots for this group of vulnerable people.

The studies show that, on average, 30% of immunocompromised patients do not develop immunity to the virus after vaccination.

Stress, Anxiety Fueling Mental Health Breakdown in Families

NJ Spotlight News reported:

By the third week in September, families across New Jersey were reaching a breaking point. Parents struggled to get their kids back into the school routine after a year of largely unstructured remote learning, while children resisted — scared of getting COVID-19 and burdened by the loss of loved ones and time with friends.

Daily calls to a state children’s health network peaked at 559 early that week, one-third higher than the volume at that point in 2020, according to data provided by the New Jersey Department of Children and Families (DCF).

The system’s mobile response unit, which visits families in crisis at home, was dispatched 150 times one day in mid-September, and nearly hit that daily peak again the following week, the data shows — a 20% increase over last year’s volume. More than 1,000 children were referred for services over two weeks, the most in months.

EU Regulator OKs Pfizer Vaccine Booster for 18 and Older

ABC News reported:

The European Union’s drug regulator gave its backing Monday to booster shots of the Pfizer-BioNTech COVID-19 vaccine for people 18 and older.

The European Medicines Agency said the booster doses “may be considered at least 6 months after the second dose for people aged 18 years and older.”

Breakthrough Infections Surge Among Vaccinated Soldiers in Yeoncheon

Korea Times reported:

A massive outbreak of COVID-19 infections has hit a military unit in Yeoncheon, Gyeonggi Province, and most of the confirmed patients had been fully vaccinated, according to the health authorities, Monday. It is the largest number of breakthrough infections here in one location.

As of Saturday, 46 soldiers in the 184-member unit tested positive for COVID-19, according to the Central Disease Control Headquarters and Ministry of National Defense. Of them, 36 were fully vaccinated ― 33 had received two Pfizer shots and the remaining three, first AstraZeneca and Pfizer second.

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