The FDA’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid, finding the medicine was safe and effective for treating COVID-19 in high-risk adults.
Paxlovid was granted emergency use authorization in December 2021. Since then, it has been used by millions of Americans to treat coronavirus infections.
This endorsement comes soon after the FDA determined the drug was effective and not linked to what has been called “Paxlovid rebound,” when symptoms return soon after finishing a course of treatment.
Treatments like Paxlovid, along with fellow COVID-19 antiviral molnupiravir from Merck and Ridgeback, became more widely known after the White House announced its Test-to-Treat initiative that aimed to give people quick and easy access to medication after testing positive for a coronavirus infection.
The drug has some drawbacks, however, as it does have known interactions with other medicines and often can’t be prescribed if it means stopping another prescription that a patient is taking.
And while full approval would put another feather in Pfizer’s cap, the company itself isn’t expecting many returns for this drug, at least this year. Pfizer is anticipating a steep drop in revenue brought in from Paxlovid for 2023, expecting a 58 percent drop as the federal government ends its purchase agreement for vaccines and treatments.
