Omicron may have FDA rethinking vaccine strategy for kids under 5 [Updated]

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

Update 1/31/2022, 10:15pm ET: Pfizer and its partner BioNTech are expected to submit a request to the Food and Drug Administration as early as Tuesday, February 1, for emergency authorization of a two-dose COVID-19 vaccine for children ages 6 months to 4 years, according to officials familiar with the situation who spoke with The Washington Post and The New York Times. According to the Post, FDA officials encouraged Pfizer and BioNTech to submit the request and data in hopes of authorizing the two doses as early as the end of February. Meanwhile, the companies will continue to collect data on a third dose for the age group.

The original story follows.

Original story 1/31/2022, 5:21pm ET: The Food and Drug Administration may be reconsidering its criteria for authorizing COVID-19 vaccine doses for children under age 5, according to Scott Gottlieb, a former FDA commissioner and a current board member of vaccine-maker Pfizer. This opens the possibility that vaccine-ineligible youngsters could get protection from severe COVID-19 sooner than anticipated.

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