TUCSON, Ariz. (KGUN) — Pfizer Inc. and BioNTech are seeking FDA approval of their COVID-19 vaccine to include children 6 months through 5 years of age.
This follows a request from the FDA for both companies to initiate a rolling submission seeking to amend the Emergency Use Authorization.
"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," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
"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. 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 has planned a virtual meeting for Tuesday, Feb. 15 at 6:30 a.m. to discuss the request.
"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. Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials," said Acting FDA Commissioner Janet Woodcock, M.D.
"In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caretakers to get vaccinated or receive a booster dose when eligible."
A livestream of the Vaccines and Related Biological Products Advisory Committee meeting may be viewed on the agency’s YouTube channel.
It will also be webcast from the FDA website.
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