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FDA’s Vaccine Advisory Committee Weighs Necessity Of Pfizer Covid Booster Shots

By News Creatives Authors , in Business , at September 17, 2021

Topline

The Food and Drug Administration’s independent advisory committee is meeting Friday to decide whether it will recommend extra doses of the Pfizer vaccine to the general public, an important decision likely influencing the Biden administration’s planned rollout of booster shots that comes as experts remain torn on their necessity. 

Key Facts

The panel, which is made up of outside experts who advise the FDA’s decisions on vaccines, is set to vote on whether it believes booster shots are safe and effective for people 16 years and older later on Friday. 

The vote will follow presentations from the FDA, CDC and Pfizer executives, as well as time set aside for questions from the public and other experts, and roughly two hours of debate among the committee members, according to a schedule posted online.

While the FDA is not required to adhere to the decision of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), it often does and has for important decisions throughout the Covid-19 pandemic. 

Following the vote, the FDA will decide whether to formally amend its current vaccine approval of Pfizer to include booster shots. 

The CDC’s advisory panel is then slated to discuss next week who should get the shots and when. 

What To Watch For 

The FDA’s decision is only related to the Pfizer vaccine. The two other vaccines approved in the U.S.—those made by Moderna and Johnson & Johnson—will have to be separately considered by the FDA and CDC on whether they should be extended for use as booster shots.  

Key Background 

This critical advisory committee meeting comes as experts, including some within the FDA, diverge on whether they believe booster shots are necessary. Studies and data released by drug companies have suggested vaccines’ protection against infection wanes over time, allowing for more so-called “breakthrough infections.” However, there is not yet evidence that the vaccines have become any less effective at preventing severe illness and death. Pfizer, in documents released Wednesday ahead of the advisory committee’s meeting, said its clinical trials showed vaccine efficacy decreased around 6% every two months after the second dose, and a third dose restored protection to 95%. But FDA scientists were lukewarm about whether these findings showed a booster dose would be necessary for the general population. 

Crucial Quote 

“Some observational studies have suggested declining efficacy of [Pfizer’s vaccine] over time against symptomatic infection or against the Delta variant, while others have not,” FDA staff members said. “However, overall, data indicate that currently U.S.-licensed or authorized Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States.” 

Contra 

Some public health experts, including leaders of the World Health Organization, have deemed booster shots currently unnecessary, arguing vaccine doses should be prioritized for countries with low vaccination rates to prevent the emergence of more dangerous variants. Earlier this week, a group of international researchers including experts from the Food and Drug Administration wrote in the Lancet medical journal that the push to roll out Covid-19 booster shots is not being driven by sound evidence and is in fact undermining overall confidence in vaccines. 

Chief Critic 

“Taken as a whole, the currently available studies do not provide credible evidence of substantially declining protection against severe disease, which is the primary goal of vaccination,” said the paper’s lead author Dr. Ana-Maria Henao-Restrepo, a researcher at the WHO.

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