FDA vaccine adviser says Covid-19 booster decision is being rushed by Biden administration’s Sept. 20 target

Three reports published Wednesday support the argument that people may need a booster dose of Pfizer’s Covid-19 vaccine over time, and suggest such boosters would be safe.

The reports are part of a batch of data that will be discussed Friday by vaccine advisers to the US Food and Drug Administration. The FDA is considering a request by Pfizer to approve a third, booster dose of its vaccine for most people six months after they get their first two doses of vaccine.

But while the FDA clearly signaled it would grant emergency use authorization to Pfizer’s and Moderna’s vaccines last December, that it would grant EUA to Johnson & Johnson’s vaccine in February and that it would fully approve Pfizer’s vaccine last month, it was notably neutral about the question of booster doses for the general public.

There are “many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” it said in a briefing document released Wednesday ahead of the meeting of its Vaccines and Related Biological Products Advisory Committee.

One of the reports is the formal presentation of data from Israel released earlier this month that showed booster doses of vaccine not only raised immunity as measured in the blood, but also showed a real-world reduction in infection.

Two others, sponsored by Pfizer, support the argument that immunity, as measured in the blood, does begin to wane over time after people get both initial doses. One shows a booster restores that immunity.

The reports, all published in the New England Journal of Medicine, are being used by Pfizer and by some federal officials to support the argument that most people will need booster doses starting around six months after they are initially vaccinated.

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