Pfizer, BioNTech delay FDA application for young kids' COVID-19 vaccine

Vials of Moderna and Pfizer-BioNTech COVID-19 vaccines in the Meuhedet Clinic in Jerusalem on January 3. Photo by Debbie Hill/UPI An Israeli healthcare worker administers a Pfizer-BioNTech COVID-19 vaccine to a boy in a Clalit vaccination center in Jerusalem on December 17. File Photo by Debbie Hill/UPI Trixie, an 8-year-old resident of the Upper West Side of Manhattan, is held as she receives a COVID-19 vaccine at the American Museum of Natural History on November 9 in New York City. Pfizer has postponed its application to the FDA for approval of a COVID-19 vaccine for kids 6 months to 4 years old. File Photo by John Angelillo/UPI

Feb. 11 (UPI) -- Pfizer and BioNTech said Friday they are delaying a Food and Drug Administration application for COVID-19 vaccines for kids 6 months to 4 years old.

Pfizer said it will wait for more data on a three-dose vaccine for kids until April, when the data is expected to be available.

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"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 in a statement.

Pfizer said the extension "allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion."

Earlier this month, Pfizer said it was expecting the vaccine for kids under 5 to get an emergency use authorization as soon as the end of February.

Pfizer's trial initially enrolled 4,500 children 6 months to under 12 years old from 90 clinical sites in the United States, Finland, Poland and Spain.

In December, Pfizer reported that two vaccine doses didn't give kids ages 2 to 4 strong enough immunity.

In light of Pfizer and BioNTech's action, the FDA postponed an advisory committee meeting set for next week to analyze Pfizer data on COVID-19 vaccines for young children.