FDA panel recommends Pfizer-BioNTech COVID-19 booster shots only for people 65 and older or at high risk

·6 min read

After hours of discussion and a request to revise the question they were asked, a federal advisory committee on Friday recommended a third dose of the Pfizer-BioNTech vaccine six months after full vaccination for people age 65 and older and those at high risk of severe COVID-19.

Pfizer had asked to make the booster available to everyone age 16 and up.

There isn’t sufficient evidence to show boosters for people under 65 are necessary, said members of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee.

Those at high risk would include health care workers, first responders and people likely to be exposed to the virus at work, committee members said.

Members said getting it right, and waiting to follow the science, were important factors.

“We may need it, but we don’t have the data yet,” said Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital.

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Pfizer thanked the committee for its "thoughtful" review of the data.

“We will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a booster dose for a broader population," said Kathrin Jansen, the company's head of vaccine research and development.

The committee doesn't make the decision for the FDA, but the FDA almost always takes its recommendations to heart. A final decision by the agency is expected over the next few days. If FDA agrees with the recommendation, the booster shot will come under an emergency use authorization.

The committee’s decision doesn’t mean booster shots for those who got Pfizer doses more than six months ago will immediately become available.

Empty vials of the Pfizer-BioNTech vaccine on January 22, 2021.
Empty vials of the Pfizer-BioNTech vaccine on January 22, 2021.

That could come next week, when a Centers for Disease Control and Prevention committee that decides how approved vaccines should be used meets. The Advisory Committee on Immunization Practices is scheduled to discuss the matter on Wednesday and Thursday.

In a somewhat unprecedented move, because of its reservations around the question of boosters, the committee decided to first hold an up-or-down vote on the question of whether to recommend a third dose of vaccine for everyone 16 and older.

The committee said the data was strongest for people 65 and older and possibly health care workers or those at high risk of disease.

The initial vote was two yes and 16 no, with the understanding that the committee would then discuss a revised voting question. After almost 20 minutes of discussion, a second question was posed.

This one narrowed the use of boosters to people 65 and over and those at high risk of severe disease.

Who will be able to get a COVID-19 booster shot and when? That's still in limbo.

The committee's vote, and its shift from what the FDA had asked, should be viewed as a good thing, said Dr. Archana Chatterjee, dean of the Chicago Medical School and a member of the committee.

"This should demonstrate to the public that the members of this committee are independent of the FDA and that, in fact, we do bring our voices to the table when we are asked to serve on this committee," Chatterjee said.

The decision flies in the face of Israel's experience. Because it vaccinated so early and quickly, it is "the proverbial canary in the coal mine," said Andrew Noymer, a professor of public health at the University of California, Irvine.

"I think the decision not to authorize third doses of the COVID vaccine for people 16-64 is an unforced error," he said.

Dueling data from US, Israel

The committee was presented with data from the USA and Israel that told different stories about how quickly and how much vaccine effectiveness waned.

U.S. data shows that overall, COVID-19 vaccines still provide high protection against severe disease, hospitalization and death.

As of September, protection against hospitalization and emergency room visits for vaccinated people remained over 82%, CDC Dr. Sara Oliver told the committee.

But protection against mild infections has decreased. Since the emergence of the delta variant, vaccine protection against COVID-19 infection has declined to 39% to 84%, depending on the region and the study.

The primary goal of COVID-19 vaccination is to protect against severe illness and death, and there, vaccine effectiveness has fallen only slightly.

Oliver told the committee various studies found protection against severe illness is at 75% to 95% effective.

This is where data from Israel is confusing. It began a national vaccination program before the USA and has one of the highest vaccination rates in the world and excellent national health data.

Experts from Israel's Ministry of Health presented data to the committee showing that as the delta variant spread, COVID-19 cases increased more than 100-fold over a month and a half in July and August. Severe cases rose tenfold, and of those, 60% were in fully vaccinated people, and 40% were in the unvaccinated.

Israel began a campaign of third doses July 20, starting with the country's older population.

“We saw that the booster dose improves the protection by tenfold against confirmed infection and at least for the elderly against severe COVID-19,” said Dr. Sharon Alroy-Preis, director of Israel’s Public Health Service. “It’s like a fresh vaccine. And the adverse events were not more acute than with the first or second shots."

The differences confounded the committee and were one of the reasons they wanted more and better data before making a broad decision on booster shots.

"Why is there such a difference between what Israel is seeing?" asked committee member Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. "Why are we still holding up, and they are not?"

The decision will allow the FDA to do a thorough study, said Norman Baylor, CEO of Biologics Consulting and the former director of FDA’s Office of Vaccines Research and Review.

“This really gives FDA the room they need and the time they need to say, ‘We know there's additional data out there, let's now review it. We know that the Israeli data is out there. Let's put that under a microscope,’” he said.

The morally right thing to do?

Though it wasn’t one of the issues the FDA asked the committee to address, hanging in the air was the question of whether it’s moral for the United States to give millions of booster doses to fully vaccinated people when so much of the world hasn’t gotten any.

A piece in the British medical journal The Lancet on Monday argued that while global supply is limited, everyone should focus on vaccinating the unvaccinated. The argument is that not only is it the morally right thing but that vaccinating the world cuts down on potential new variants and, in the end, protects the USA.

The World Health Organization asked rich countries to wait until at least the end of the year to begin booster shots for healthy people.

This article originally appeared on USA TODAY: FDA panel approves Pfizer boosters for people over 65, at high risk

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