In Reversal, F.D.A. Delays Push for Shots for Children Under 5
The New York Times
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.
WASHINGTON — In a striking reversal, federal regulators said on Friday that they would wait for data on how well three doses of Pfizer-BioNTech’s coronavirus vaccine work in children younger than 5 before deciding whether to authorize the vaccine for that age group.
The decision by the Food and Drug Administration most likely rules out shots for roughly 18 million of the nation’s youngest children until at least April. The Biden administration had been hoping to expand vaccination to those 6 months through 4 years of age as early as next week. They are the only Americans not yet eligible for shots.
Pfizer-BioNTech asked for the delay after the companies discovered that the Omicron wave had led to a far higher rate of infection than they had previously recorded among young volunteers in their clinical trial. The new data underscored that the Omicron variant was better than the earlier Delta variant at evading the vaccine’s protection, and it showed that two doses, which had already fallen short by another measure, were not effective enough.
