Access to Paxlovid Without Testing Approved

The U.S. Food and Drug Administration (FDA) issued an updated Emergency Use Authorization (EUA) stating that the oral antiviral Paxlovid™ is now offered to people with a SARS-CoV-2 coronavirus infection without a confirmatory test.

On February 1, 2023, Patrizia Cavazzoni, M.D. Director Center for Drug Evaluation and Research with the FDA published EAU #105, confirming certain adults and pediatric patients can be prescribed Paxlovid without completing a diagnostic test.

However, there are known drug interactions that should be reviewed.

Pfizer previously confirmed Paxlovid is contraindicated in patients with a history of clinically significant hypersensitivity reactions to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product and with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions. 

Therefore, before prescribing Paxlovid, clinicians should carefully review the patient's concomitant medications, including over-the-counter medicines, herbal supplements, and recreational drugs, says the U.S. NIH.

Pfizer Inc., Paxlovid's producer, stated on January 31, 2023, it expects a 58% reduction in related revenues in 2023.