Pfizer seeks emergency authorization on COVID vaccine for children 6 months and up
Pfizer and BioNTech announced they are seeking the Food and Drug Administration's emergency authorization for their COVID-19 vaccine for children 6 months through four years old.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer CEO Albert Bourla said in a press release.
"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," Bourla said. "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."
BioNTech founder and CEO Dr. Ughur Sahin said: "Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old."
Children six months and up may be able to receive the Pfizer vaccine by the end of Feburary. The Pfizer vaccine is currently available for use in older children.