FDA to Clear Third Pfizer Dose for Older, At-Risk Americans

(Bloomberg) — The Food and Drug Administration plans to authorize a third dose of the Pfizer Inc.-BioNTech SE Covid-19 vaccine imminently, according to people familiar with the matter. 

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The expected emergency clearance for the booster shot will be for people 65 and older, those most susceptible to severe disease and people whose jobs put them at risk, the people said. An announcement is planned for Wednesday, the people said. 

An FDA spokesperson declined to comment. Pfizer representatives didn’t immediately respond to a request for comment.

An emergency clearance would be line with a recommendation last week from FDA advisers but narrower than the full approval Pfizer had sought. It means that the Biden administration would have to forgo, temporarily, a wider rollout of boosters that it had proposed last month. Third doses are already authorized for certain people with compromised immune systems.

Read More: FDA Panel Backs Pfizer Booster for 65 and Up, Rejects Broad Use

However, the authorization would leave the door open for the FDA to consider broader use of boosters, including in younger adults, as more data on their safety and efficacy become available. And it assures that many of the older Americans who were first in line for the initial shots will be among the earliest to get additional protection.

A surge in virus infections caused by the delta variant has coincided with fears that vaccine potency will fade as the weather turns colder. Real-world studies suggested that the efficacy of the Pfizer vaccine diminished somewhat this summer, especially in preventing mild breakthrough cases, though it is hard to distinguish waning immunity from the effects of the highly infectious delta variant.

Pfizer shares rose 0.2% in after-hours trading on Wednesday, while shares of BioNTech gained 0.4%. 

CDC Review

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to meet Thursday to make its own recommendations about who should receive the additional dose. 

The panel, made up of outside vaccine experts, met Wednesday for a general review of vaccine efficacy over time and booster-shot science. 

Some members raised the question of whether people who had received a Moderna Inc. or Johnson & Johnson vaccine for their primary immunization should receive the Pfizer booster, or whether they should wait to match with a supplemental dose of the shot they first received. 

FDA vaccine official Doran Fink told the panel on Wednesday that the agency is “working as rapidly as possible” to review Moderna’s booster submission.

Since the FDA said Aug. 13 that people with weakened immune systems can receive a third shot, more than two million Americans have gotten one, according to CDC data. 

Dosing Debate

Use of a third shot to protect vulnerable people was backed by recent evidence from other countries. An Israeli study in the New England Journal of Medicine showed a third dose of the Pfizer vaccine can dramatically cut rates of Covid-related illness in people 60 and older. 

Additionally, a Pfizer study suggested that the efficacy of its first two shots waned in a matter of months, and that booster doses are an effective way to combat the spread of the virus and new variants.

Some critics have said that booster shots should wait until immunizations are more widespread globally. World Health Organization Director-General Tedros Adhanom Ghebreyesus has argued that uneven vaccine distribution will be the world’s biggest obstacle to ending the pandemic and recovering. 

Prior to last week’s meeting of the vaccine advisory panel, top scientists and two FDA officials, in a review published in The Lancet, questioned the scientific support for a third shot, saying available doses would be better used to immunize the unvaccinated.

(Updates with stock-price information in seventh paragraph and more detail on study data in final section)

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