FDA Bypasses Advisory Committee to Approve 4th Dose of COVID Vaccine


The Food and Drug Administration has approved a second COVID-19 booster dose of either Pfizer or Moderna for older people and some immunocompromised individuals.

This is the fourth Pfizer and Moderna Covid vaccine dose approved, CNBC News reported.

The FDA previously authorized a single booster dose for immunocompromised people after they had finished the primary, three-dose vaccination series, the FDA news release reported.

This new booster dose is meant to protect those who are at higher risk for severe medical complications from COVID.

“This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns,” the FDA reported.

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However, as CNBC News reported, the decision to approve a second booster came without the FDA’s vaccine advisory committee meeting. This is “a rare move the agency has made more frequently over the course of the pandemic to expand uses of already-approved Covid vaccines,” CNBC News reported.

But the FDA believes that some weakening of vaccine protection over time leaves elderly and immunocompromised individuals in greater danger.

“Current evidence suggests some waning of protection over time against serious outcomes from Covid-19 in older and immunocompromised individuals,” Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said, the FDA news release reported.

“Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna Covid-19 vaccine could help increase protection levels for these higher-risk individuals,” Marks added.

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Marks also encouraged anyone who has not had the initial booster to get it.

In addition, he explained in a call with reporters that this fourth dose reduces overall risk of COVID.

“This fourth booster dose is something that evidence that we have now from Israel suggests that by getting this, one can reduce the risk of hospitalization and death in this population of older individuals,” Marks said, CNBC News reported.

But one Johns Hopkins professor and a member of the National Academy of Medicine is doubtful of this new FDA decision and how it bypassed the vaccine committee.

Dr. Marty Makary tweeted that this may not be the best decision.

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“Is this following the science?? FDA will authorize 4th doses this week by bypassing the typical voting process of their external experts. FDA will then convene them after the [authorization] to “discuss”. It’s like a judge issuing a verdict and then having lawyers make their arguments,” he argued in a tweet.

Makary also pointed out that many agree there has not been enough data on this fourth dose, so there is uncertainty surrounding this new FDA decision.

Dr. Eric Rubin, who is the editor in chief of The New England Journal of Medicine and sits on the FDA’s Vaccines and Related Biological Products Advisory Committee, said he has not seen enough data on the fourth dose to make a decision about whether it is needed, CNN reported.

“The only data that I’ve seen has been for participants followed for just a few weeks. The most important information is going to be how well a fourth dose protects highly vulnerable people against serious disease and death, and I don’t know when that will be available,” Rubin said in an email to CNN. Rubin admitted that the FDA might have access to that data.

But there is still doubt over the doses and the continual new recommendations.

“Public weariness with pandemic regulations and official advice, meanwhile, has been deepened by confusion over changes such as that regarding second booster shots,” the U.K’s Guardian reported.

John P. Moore, professor of microbiology and immunology at Weill Cornell Medicine in New York, also had questions.

Moore told The Washington Post, “I’ve been getting multiple inquiries from lay friends over the past few days: ‘What does this mean, and what should I do?’”

“I find it increasingly difficult to tell friends what they should do,” he added. “It’s becoming really problematic.”

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