FDA says Pfizer COVID tablet EUA for adolescents to remain even after nod for adults

(Reuters) – The U.S. well being regulator stated on Thursday the present emergency use authorization (EUA) for Pfizer’s COVID-19 antiviral tablet for high-risk adolescents will proceed to stay in impact even when it receives full approval to be used in some adults.

Paxlovid has been approved for emergency use in mild-to-moderate COVID sufferers aged 12 years and older since late 2021, however Pfizer’s software for full approval solely covers high-risk adults.The Meals and Drug Administration, in a presentation launched forward of its advisers’ assembly, stated the dialogue is not going to give attention to Paxlovid’s use in youngsters as drug improvement for the inhabitants group is ongoing.

“Ought to this new drug software be accepted, FDA anticipates that the EUA for Paxlovid will stay in impact to proceed authorizing therapy of adolescents with mild-(to-)reasonable COVID-19 and additional tackle different entry wants,” the regulator added.

A full approval would supply docs extra flexibility in prescribing the drug and likewise enable the corporate to develop its promoting marketing campaign.

(Reporting by Leroy Leo and Khushi Mandowara in Bengaluru; Modifying by Saumyadeb Chakrabarty and Krishna Chandra Eluri)