FDA Panel Weighs Covid-19 Booster Shots as Health Officials Debate

FDA Panel Weighs Covid-19 Booster Shots as Health Officials Debate

The Biden administration’s pressure to introduce widespread Covid-19 vaccine enhancers faces a test as a Food and Drug Administration advisory panel meets to weigh evidence on the extra shots, a topic shared by federal health officials.

The external panel of about 20 scientific advisors met on Friday to review information on Friday about Pfizer Inc.

and the declining protection of the BioNTech SE vaccine against Covid-19 over time and how humans tolerated additional doses. It will hear presentations from Pfizer, which has asked regulators to clear booster shots for people 16 years and older, and the FDA, which this week said all shots cleared for use in the United States are still effective without boosters. The panel will also consider contrasting scientific data on the additional shots.

Given how divisive the topic of boosters has become within the federal government and among public health experts — and the limited crucial data available to the public — it is unclear how the committee will vote.

Peter Marks, director of the FDA Center for Vaccine Supervision, opened the meeting, saying, “We know there may be different opinions” on boosters and encouraged debate on the subject. He said the FDA was obligated to focus on the science that would drive its decision-making.

In the afternoon, the committee will vote on whether the safety and efficacy data from Pfizer’s clinical trials support FDA approval of a booster dose administered at least six months after the second dose to persons 16 years of age and older.

A possible outcome of the meeting could be that the panel only recommends booster shots for certain high-risk groups, e.g. Healthcare professionals or people 65 years and older, according to people familiar with the matter.

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Anything other than a full throat approval could complicate the Biden administration’s plan to start distributing extra shots next week to boost immunity among those vaccinated and discourage highly transmissible variants of the virus, such as Delta.

If the Advisory Committee on Vaccines and Related Biological Products recommends the approval of boosters, the FDA may move within a few days to approve the distribution. The FDA is not obligated to accept any decision from the panel, but does so in general.

“There will be a very careful discussion – who should have the boosters – and it will be an open discussion,” Arnold Monto, acting chairman of the FDA panel and an epidemiology professor at the University of Michigan, said Thursday.

Covid-19 vaccines remain extremely protective against the virus, although some studies show declining efficacy. Evidence supporting the need for an extra dose, at least among the general public, has not been conclusive, according to some medical experts.

The panel will sort through scientific data showing different degrees of declining immunity in vaccinated people in different parts of the world. They will also consider data examining the efficacy of additional doses to protect humans from becoming ill with Covid-19. An extra shot a further mobilizes the body’s immune system to protect against the virus, especially variants like Delta.

The Biden administration announced that Americans who are fully vaccinated with a two-dose Covid-19 treatment should receive a booster with reference to the threat from the highly contagious Delta variant. WSJ breaks down what you need to know. Photo: Hannah Beier / Reuters

Pfizer has said that protection from the vaccine decreases over time, pointing to declining antibody levels, and that an extra dose is needed about six months after the other in its two-shot treatment to maintain protection. In a panel post, Pfizer cited real-world data from Israel and the United States, suggesting that the vaccine’s declining protection was due to more declining efficacy than the Delta variant’s spread.

The FDA said this week that Pfizer’s analysis of a third dose met the criteria for a safe and effective vaccine. Nevertheless, the agency also said that vaccines cleared in the United States currently provide adequate protection against serious illness and death from Covid-19 without additional doses. The FDA also said the decision on booster authorization should consider whether existing dosing regimens protect against variants.

Among those expected to present to the panel is Marion Gruber, director of the FDA’s vaccine research office. Dr. Gruber is set to leave the agency in late October in part due to disagreements over the Biden administration’s booster strategy, according to people familiar with the matter. She co-authored a review article in the Lancet along with another FDA colleague, Philip Krause, and other researchers who said there was not enough evidence to justify boosters to the public. Dr. Krause, who will also be leaving the FDA in the coming months, will also attend the meeting.

Should the FDA clear booster shots, a separate committee of external experts advising the Centers for Disease Control and Prevention to meet next week should also provide input. The CDC recommends who prioritizes vaccinations and when.

White House Press Secretary Jen Psaki acknowledged the booster debate on Thursday, saying, “Of course we respect a number of views, but we really trust the people who run our health and medical agencies, and there is broad agreement among these people on where things stand. ”

She said the Biden administration was ready to implement its plan once the approval process was complete. The administration and the pharmaceutical companies have said that there must be enough supply for the boosters if they are approved for distribution this month. Federal officials said boosters would be administered for free in the United States

Pfizer’s application contains data from more than 300 subjects in the clinical trial who received a third dose and showed significant increases in neutralizing antibodies that are important in the immune response to Covid-19.

No new serious safety concerns were found in people receiving the booster shots, Pfizer said, reporting side effects such as fatigue or fever similar to those previously reported in subjects.

Federal officials have said booster shots would be administered for free nationwide.


Photo:

Emily Elconin / Getty Images

The panel will also hear from Israeli researchers whose data US officials have cited to support further doses. A study published online Wednesday in the New England Journal of Medicine, which analyzed records of 1.1 million people, found that the rate of infection and serious illness was significantly lower among study participants aged 60 and over who had been vaccinated at least five months earlier and thereafter. received a booster dose of the Pfizer vaccine.

It will also hear from a researcher in the UK who will present information on the reality of Covid-19 vaccines. Prime Minister Boris Johnson said this week that Britain would start boosters for people over 50 to avoid new lockdowns.

At the request of the FDA, Pfizer provided data showing how a booster would perform against the Delta variant. In 11 subjects between the ages of 18 and 55 who received a booster, neutralizing antibodies were five times higher one month later, compared to one month after their second shot, the data showed. In 12 older subjects, the increase was 12-fold.

Federal officials recommended in August that adults 18 and older who received a two-dose treatment with mRNA vaccines, such as Pfizers, begin receiving boosters eight months after the second dose, although The Wall Street Journal reported that U.S. officials likely will approve boosters starting at. at least six months thereafter.

Health authorities have already approved booster shots for people 12 years and older whose immune system is compromised.

Write to Jared S. Hopkins at jared.hopkins@wsj.com and Felicia Schwartz at felicia.schwartz@wsj.com

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