Pfizer asks FDA to authorize COVID-19 vaccine for kids under 5

Pfizer and BioNTech have submitted an emergency-use authorization request to the FDA for their two-dose COVID-19 vaccine regimen for 6-month-olds to 5-year-olds, The Washington Post reported Feb. 1. 

The submission comes just hours after the Post first reported the drugmakers planned to submit a request as early as Feb. 8. The drugmakers are still analyzing data on a three-dose regimen for the age group, as trial results from December showed the two-dose regimen did not generate a strong immune response in 2- to 4-year-olds, though it did trigger a protective response in children 6 months to 2 years. 

In a statement shared with the news outlet, the drugmakers said federal regulators in a rare move requested they submit their application for the two-dose regimen due to "the urgent public health need in this population," adding that 1.6 million children younger than 4 have tested positive for the virus since the start of the pandemic. 

"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," Pfizer CEO Albert Bourla said in a statement to the Post. "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."

Had the drugmaker waited for data on a third shot, the vaccine would likely not have been available for young children until at least late March. If authorized by the FDA and recommended by the CDC, the vaccine could become available by the end of February. An FDA advisory committee is set to meet Feb. 15 to discuss the request.

 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars