FDA grants EUA for Pfizer’s COVID-19 oral drug

On December 22, 2021, the FDA granted EUA for Pfizer’s COVID-19 drug called Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 disease in 12+ year olds. The drug should be given early; within 5 days of symptom onset. This makes it the first “approved” treatment before hospitalisation. [1, 2, 3, 4, 5]

“Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations.” “Paxlovid is not authorized for use for longer than five consecutive days.”

This follows on from UK govt. approving Merck’s mutagenic drug molnupiravir. [6]  A drug that mutates SARS-CoV-2 creating the potential for someone to shed mutant virus variants for several days.

Australia’s TGA is considering Pfizer’s Paxlovid and Merck’s molnupiravir for provisional registration, and generally they follow what the FDA approve. [7, 8]