Pfizer requests emergency use of COVID-19 vaccine for children under 5

Feb 02, 2022 - 08:19 AM
FDA product update

Pfizer yesterday asked the Food and Drug Administration to authorize for emergency use two 3-microgram doses of its COVID-19 vaccine for children aged 6 months through 4. Pfizer said it expects to submit data in the coming weeks to expand the request to a third dose at least 8 weeks after the second dose.

“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants,” said Chairman and CEO Albert Bourla. “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”

The FDA’s vaccine advisory committee plans to discuss Pfizer’s emergency use authorization request on Feb. 15. 

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge,” said Acting FDA Commissioner Janet Woodcock, M.D.
 

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