Covid Shots For Young Kids Now Months Away After FDA Reverses Review Plan
The FDA's irregular proposal to fast-track its review of Pfizer-BioNTech's covid vaccine for kids under 5 were abruptly tabled in order to gather more data on the efficacy of a third low-dose shot. That pushes the timetable out to at least April.
AP:
In Reversal, FDA Puts Brakes On COVID Shots For Kids Under 5
COVID-19 vaccinations for children under 5 hit another monthslong delay Friday as U.S. regulators abruptly put the brakes on their efforts to speed review of the shots that Pfizer is testing for youngsters. The Food and Drug Administration, worried about the omicron variant’s toll on kids, had taken the extraordinary step of urging Pfizer to apply for OK of the extra-low dose vaccine before it’s clear if tots will need two shots or three. The agency’s plan could have allowed vaccinations to begin within weeks. (Neergaard and Perrone, 2/11)
Stat:
Pfizer Pulls Back From Plan To Expedite Review Of Covid Shots In Young Kids
Plans to attempt to authorize the Pfizer/BioNTech Covid vaccine for children under 5 before full data are available appear to have run aground. The Food and Drug Administration on Friday canceled a key meeting of its vaccines advisory committee that had been slated for next Tuesday to discuss the submission, saying that the delay “will give the agency time to consider … additional data.” Both the FDA and the companies suggested the application for authorization won’t proceed until there are data showing how well the vaccine works after a third dose. Those data should be available in early April, the companies said. (Herper, Florko and Branswell, 2/11)
The New York Times:
F.D.A. Delays Review Of Pfizer’s Covid Vaccine For Children Under 5
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. As a result, the companies and the F.D.A. agreed to wait for the results from a third dose, which are expected in early April. (LaFraniere and Weiland, 2/11)
