Profile

The agency will wait for data on whether three doses of Pfizer-BioNTech’s Covid vaccine are effective in young children after new, disappointing data.

The Food and Drug Administration asked to review Pfizer’s data on two doses now, while the company continues to assess whether three doses would be...

The move clears the way for millions of teenagers to receive an additional shot, with a top regulator citing evidence that the effectiveness of two...

Covid-19 was “the eighth-highest killer of kids in this age group over the past year,” said a C.D.C. official in favor of broader authorization.

The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps as early as next week, a long-awaited development that would affect 28...

The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.

Those eligible for the extra shot would include adults over 65 and others at high risk — the same groups now eligible for a Pfizer-BioNTech...

The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider it.

The committee said there was insufficient evidence to recommend third shots for all adult recipients of the vaccine, as Pfizer had requested.