FDA Panel OKs Pfizer Booster Shot for People 65 or Older, But Not Younger

An advisory panel to the U.S. Food and Drug Administration on Friday recommended a third Pfizer-BioNTech COVID vaccine booster shot for all Americans aged 65 or older, as well as for those deemed to be at high risk for severe illness.

According to The New York Times, that vote came after a near unanimous decision (16 to 2) by the same independent panel of experts that said no to booster shots for Americans younger than 65.

The recommendation against booster shots for younger adults is a setback for the Biden administration, which earlier in the summer had pledged a rollout of boosters to the general population by this coming Monday, Sept. 20.

FDA advisory committee decisions are not binding on the agency, but it usually does follow its advisors’ recommendations.

Following an official ruling by the FDA — expected sometime next week — the U.S. Centers for Disease Control and Prevention would meet to outline how any new doses should be used.

According to the Times, Dr. Peter Marks, the official who directs the FDA’s vaccine division, had urged panel members to not only focus on severe illnesses when making their decision, but also the power of boosters to perhaps slow infection rates.

The two votes come after a day of intense discussion and presentations from Pfizer, which has pushed hard for third booster shots, as well as officials at the CDC. The agency has conducted studies that suggest that the two doses of Pfizer vaccine that tens of millions of Americans have already received are still keeping recipients safely out of the hospital.

Panel members also heard testimony from Israeli experts. Israel began doling out booster shots to its already well-vaccinated population earlier this summer. The Israeli data appears to suggest that a third shot does give a significant boost to immunity from severe illness.

However, Dr. Sara Oliver of the CDC presented data that current doses are still protecting even the very old from serious COVID-19.

One study published Friday in a CDC journal tracked the vaccination histories of almost 3,700 American adults hospitalized from March through mid-August. It found that those who had received two doses of the Pfizer vaccine still maintained 88% protection against being hospitalized with COVID-19.

In the Israeli study, published Sept. 15 in the New England Journal of Medicine, more than one million Israelis aged 60 and older received a booster dose. The study found that they were much less likely to become infected soon after with the contagious Delta variant, achieving what Pfizer called “roughly 95% effectiveness.” It is not known how long that protection will last, however.

Another Israeli scientist pointed to data on 1.1 million people over the age of 60 in that country. Crunching the numbers, the data suggests that 12 days after their booster shots, rates of severe disease fell 20-fold among those who had received the third shot, compared to people who had not.

However, many of the FDA committee members seemed skeptical of the Israeli data, suggesting that it wasn’t appropriate to compare the relatively small, homogenous country with a nation as populous and diverse as the United States.

Another CDC official, Dr. Amanda Cohn, queried Israeli officials on why the spread of coronavirus infections there had recently intensified, despite a broad rollout of boosters.

And there was another key point of contention: Jonathan Sterne, a professor of medical statistics and epidemiology in the United Kingdom, told panelists that the Israeli data only included a few weeks of follow-up in its older cohort.

Sterne said he had examined data from 76 different studies on the vaccines’ effectiveness in the real world. He contended that many disparate factors can alter the study results, including how many unvaccinated people in a study have gained some level of natural immunity from prior COVID-19 infections.

In the end, many committee members worried that a rollout of boosters to the healthy young wasn’t yet justified.

“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,” said Dr. Michael Kurilla, a committee member and official at the U.S. National Institutes of Health, the Times reported.

The panel’s decision against boosters for people under 65 wasn’t entirely surprising. Earlier, two high-ranking FDA scientists co-authored an article in The Lancet journal that said there simply isn’t enough solid evidence to back booster shots for the general population. Both scientists are planning to leave the FDA this fall, the Times said.

More information

Find out more about COVID-19 vaccines at the CDC.

SOURCES: The New York Times, Morbidity and Mortality Weekly Report

Source: HealthDay