FDA says Pfizer COVID pill EUA for adolescents to stay even after nod for adults
2023.03.16 14:50
© Reuters. FILE PHOTO: The Pfizer logo is pictured on their headquarters building in the Manhattan borough of New York City, New York, U.S., November 9, 2020. REUTERS/Carlo Allegri/
(Reuters) – The U.S. health regulator said on Thursday the current emergency use authorization (EUA) for Pfizer (NYSE:)’s COVID-19 antiviral pill for high-risk adolescents will continue to remain in effect even if it receives full approval for use in some adults.
Paxlovid has been authorized for emergency use in mild-to-moderate COVID patients aged 12 years and older since late 2021, but Pfizer’s application for full approval only covers high-risk adults.The Food and Drug Administration, in a presentation released ahead of its advisers’ meeting, said the discussion will not focus on Paxlovid’s use in children as drug development for the population group is ongoing.
“Should this new drug application be approved, FDA anticipates that the EUA for Paxlovid will remain in effect to continue authorizing treatment of adolescents with mild-(to-)moderate COVID-19 and further address other access needs,” the regulator added.
A full approval would provide doctors more flexibility in prescribing the drug and also allow the company to expand its advertising campaign.
