FDA Hints J&J Booster Jab May Be Beneficial, But Remains Mum On Approval Odds
With just one day left before the FDA’s vaccine advisory committee meets in person to discuss booster-jab submissions from Moderna and J&J, the FDA has just shunned Moderna once again by suggesting that the agency might approve the J&J booster jab, one day after it suggested that Moderna’s jab is still “too effective” to justify recommending a third jab.
However, the agency’s scientists also lamented the paucity of data submitted by J&J, and questioned the strength of the evidence submitted.
The panel’s decision on Friday could have significant influence on whether the 15 million Americans who have received the one-dose vaccine will be allowed to get a second shot, or if they will instead be urged to get a different brand of vaccine for added protection.
Pfizer’s jab has already been granted emergency approval for boosters in patients who are elderly or immuno-compromised. However, when it comes to J&J, the data to support a booster remains limited, and the agency hasn’t verified all the information yet.
“Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose, when compared to the efficacy seen in the pivotal study COV3001,” they wrote in a 54-page document published on Wednesday.
The main reason why the FDA might consider approving a booster jab for J&J is that data show the J&J jab simply isn’t as effective as the Pfizer and Moderna jabs, so those who have received it might be better off receiving a booster dose to keep their immunity levels high.
“The highest effectiveness estimates (including for more severe COVID-19 disease) across clinical trials and real-world effectiveness studies evaluating the Janssen COVID-19 Vaccine are consistently less than the highest effectiveness estimates for the mRNA COVID-19 vaccines,” they said.
“Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose,” the agency said in its report.
Overall, the data show that single-shot J&J vaccine “still affords protection against severe COVID-19 disease and death in the United States.”
The report by FDA scientists is meant to brief the agency’s Vaccines and Related Biological Products Advisory Committee, which will meet Thursday to discuss he Moderna jab and Friday to discuss data on the safety and effectiveness of a second J&J jab. T
The documents published so far offer a glimpse of the agency’s view on additional shots.
J&J, which uses a modified adenovirus to elicit an immune response, asked the FDA to approve a booster shot of its one-dose vaccine for people ages 18 and older on Oct. 5.
The briefing documents appear to suggest that the FDA is leaning toward authorizing a J&J booster jab, while the agency’s advisory panel appears to be leaning toward rejecting a Moderna booster, at least for now, because – as we said – their data suggests the Moderna jab retains immunity for longer.
Read the FDA’s full J&J briefing documents below:
Wed, 10/13/2021 – 13:09