FDA delays process for Pfizer vaccine for children under 5: WebMD

“In a striking reversal, federal regulators said on Friday that they would wait for data on whether three doses of the [Pfizer-BioNTech] coronavirus vaccine are effective in children younger than 5 before deciding whether to authorize a vaccine for the age group,” WebMD reported Friday. “The Food and Drug Administration will postpone a meeting of outside experts that was scheduled for Tuesday; the experts were to weigh the evidence and make a recommendation on whether to authorize two doses of the vaccine in young children, as Pfizer had requested. In a news release, Pfizer-BioNTech said that their three-dose trial for young children was moving briskly, and that the new timetable would allow the F.D.A. to get more data and thoroughly review it. Results are expected in early April. ‘Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,’ the companies said. Regulators and vaccine manufacturers have been wrestling with how quickly to move to vaccinate roughly 18 million children under 5, the only Americans still ineligible for shots. The highly transmissible Omicron variant is receding in much of the nation, but federal officials have said that nearly 400 children under 5 have died of Covid-19.” WebMD, “FDA delays process for Pfizer vaccine for children under 5.”