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

Pfizer yesterday 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.
鈥淯ltimately, 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,鈥 said Chairman and CEO Albert Bourla. 鈥淚f 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.鈥
The FDA鈥檚 vaccine advisory committee plans to discuss Pfizer鈥檚 emergency use authorization request on Feb. 15.
鈥淗aving a safe and effective vaccine available for children in this age group is a priority for the agency and we鈥檙e committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge,鈥 Acting FDA Commissioner Janet Woodcock, M.D.