FDA's expert panel backs Covid-19 booster shots for adults 65+ and those at high risk of severe disease

Business Insider US
A vial of Johnson & Johnson (Janssen's) Covid-19 vaccine.
  • An expert panel recommended that the FDA authorize booster shots for older and vulnerable adults.
  • The doctors and health experts who advise the FDA say data suggests younger people are still well protected.
  • The panel vote down a proposal to make boosters available to everyone 16 and older.
  • For more stories visit Business Insider.

An expert panel advising the Food and Drug Administration said on Friday that a booster shot of Pfizer's coronavirus vaccine should be made available to older adults and others at high risk from the pandemic, under an emergency use authorization.

While the committee was persuaded by the evidence that a third dose of the Pfizer-BioNTech vaccine would help those at highest risk, the group was not convinced to include younger people for now.

The group initially voted 16-2 to reject the idea of a third dose for everyone 16 years and older. That was a defeat for Pfizer, which wanted to make the booster shots widely available.

Committee members then proposed the more limited recommendation that FDA issue an emergency use authorisation for the booster dose for those over 65, and for people at high risk of severe cases of Covid-19. The vote for that proposal was unanimous.

Experts have said there is a clearer rationale and more data supporting booster doses for this population. Several experts previously told Insider that boosters should be rolled out now for older adults.

The FDA isn't required to follow the recommendations of its advisory committees, meaning it could still decide to approve booster shots for everyone 16 and older.

The FDA's interim leader, Dr. Janet Woodcock, had signed on to an August 18 joint statement from a range of government health leaders that stated booster shots would be needed for the general public and would start rolling out on September 20, pending FDA and CDC reviews.

Experts have criticized Biden's booster-shot plan for being prematurely announced and potentially applying political pressure to the FDA and CDC review processes.

The votes could also weigh heavily on other booster-shot applications. Moderna has applied for FDA approval for a third dose, and Johnson & Johnson has also described preliminary data on giving an extra dose of its single-shot vaccine.

Several experts on the panel expressed concern that there wasn't enough safety data for the booster shot to recommend approving it for younger adults. In particular, they highlighted the risk of myocarditis, or heart inflammation, that has been seen at higher-than-usual levels in teenagers and 20-somethings who have been vaccinated.

Data presented to FDA panel leans on Israel's experience

Some of the most compelling data in favor of boosters comes from Israel, which began rolling out a booster to its older population at the end of July and has since offered it to people as young as 12.

Israeli health officials presented data to the panel showing a dramatic decrease in infections and severe disease, particularly among older people. Their study compared people who got boosted to people who had received two doses and no booster.

Israel would have likely exceeded its hospital capacity if the nation waited longer to give boosters, Dr. Sharon Alroy-Preis, head of public health services for Israel's health department, told the committee.

Pfizer presented data showing protection from its vaccine against infection waned over time, particularly at six to eight months out. But a study from Kaiser Permanente's healthcare system showed protection against hospitalization was durable, remaining just as high five months out from vaccination.

However, in a sign of how fast-moving the Covid-19 research space has been, the CDC released a new study Friday afternoon that showed a statistically meaningful drop in the protection that Pfizer's vaccine offers against hospitalization. After four months, hospitalization protection dropped from 91% to 77%.

The Israel data suggests that the booster can restore the initial highs of vaccine protection against infection. But there's no long-term data to know if that infection protection will last longer this time around. And the FDA's review made it clear the agency believes the vaccines are still working quite well at preventing hospitalization and death.

Still, getting unvaccinated people vaccinated is the top priority in the US.

"At this moment, it is clear that the unvaccinated are driving transmission in the United States" Amanda Cohn from the CDC said during the meeting.

Cohn said that masks and social distancing "will have to be part of the solution" too, because "vaccination will never be perfect" at preventing every case.

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