FDA, Pfizer abandon 2-shot COVID vaccine in kids under 5, citing new data

Enlarge / A child getting a vaccination on February 19, 2021, in Bonn, Germany. (credit: Getty | Ute Grabowsky)

The Food and Drug Administration, Pfizer, and BioNTech announced on Friday that they are abandoning plans to pursue the authorization of a two-dose regimen of COVID-19 vaccines for children ages 6 months to 4 years. Instead, they will again put the possibility of an authorization on hold as they await data on the efficacy of a third dose for the youngest children. That data is now expected in early April.

In a press release this afternoon, Pfizer and its partner BioNTech reported that COVID-19 cases among children enrolled in the initial two-dose trial "continue to accumulate according to the study protocol, and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent omicron surge."

"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 press release continued.

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