WASHINGTON — Pfizer mentioned it will ask the Meals and Drug Administration on Friday to permit emergency use of its coronavirus vaccine.
That will make the corporate and its German associate, BioNTech, the primary coronavirus vaccine builders to submit their shot for overview by U.S. regulators. The FDA is is predicted to problem a choice inside weeks.
The businesses mentioned their submission will embrace security information on 8,000 folks beneath age 18, together with 100 within the 12-15 age vary — probably setting the vaccine up to be used by youngsters. Information the businesses launched this week additionally confirmed the shot was 94 p.c efficient within the aged, whose immune methods are typically weaker than these of youthful adults or youngsters.
Pfizer and BioNTech introduced earlier this week that the shot was secure and 95 p.c efficient in a late-stage trial with almost 44,000 members. That end result held true throughout age, gender, racial and ethnic classes.
The businesses additionally mentioned that negative effects from the vaccine have been gentle, with the commonest together with fatigue and headache.
However the pair needed to wait to hunt FDA permission to start advertising and marketing the vaccine till that they had collected two months of security information on at the very least half of their trial members.
What’s subsequent: The FDA’s unbiased vaccine advisory group is predicted to overview the information on Pfizer and BioNTech’s vaccine at a gathering in early December.
The company shouldn’t be obligated to comply with the suggestions of the advisory panel, however it usually does. The FDA may determine whether or not to grant the emergency authorization quickly after.
One other vaccine developer, Moderna, is predicted to quickly search FDA authorization for its COVID shot, which was 95 p.c efficient in preliminary information.
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