FDA axes requirement for positive Covid test before Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Walid Gellad

Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told Endpoints News that “Paxlovid is right now the only good option for outpatient treatment of Covid, and the last thing we want to do is give it to people who don’t have Covid just for convenience.”

“I can understand the desire to get people at high risk the treatment, but it has to be very rare that someone tests negative and is unable to get a PCR or test again the next day and then get treated. It seems this is a policy that will address a minuscule slice of underuse and lead to a large increase in overuse,” Gellad added.

Paxlovid resistance has been documented in the months since the therapy was given emergency authorization back in December 2021. Science writer and chemist Derek Lowe said last summer that resistance to the antiviral was a question of not if, but when — pointing to mutations in the coronavirus, specific places in the protein sequence that could theoretically lead to viral sequences, and referencing a number of potential mutation sites that could be feasible in the real world.

Eric Topol, director of the Scripps Research Translational Institute, told Endpoints at the time that “the likelihood of resistance is high,” adding that “Many Mpro [main protease] function mutations, occurring naturally, have already been identified.”

Additionally, Merck’s Lagevrio — also known as molnupiravir — had its authorization changed Wednesday, allowing adults to be prescribed the now much lesser-used antiviral without a positive test. This is after the FDA moved last year to restrict who can prescribe the antiviral to only “traditional prescribers (e.g. physicians, advanced practice registered nurses, and physician assistants),” the FDA told Endpoints back in July.

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