FDA No Longer Requires Positive COVID-19 Test to Use 2 Antivirals


The agency said it was revising the Emergency Use Authorizations (EUA) for Lagevrio and Paxlovid in order to protect public health.

Yesterday, the FDA released letters to Merck and Pfizer, the manufacturers of molnupiravir (Lagevrio) and nirmatrelvir/ritonavir (Paxlovid) respectively, informing them they have revised the EUAs for these 2 antivirals to allow people with COVID-19 to use the antivirals without a positive test.

In both letters to the manufacturers, Patrizia Cavazzoni, MD, director, Center for Drug Evaluation and Research US, FDA offered the following: “a current diagnosis of mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death," as justification for usage for both therapies.

Lagevrio is authorized for adults 18 years and older and Paxlovid is authorized for adults and pediatric patients who are 12 years of age and older weighing at least 40 kg.

The agency stated specific data from trials for each to demonstrate their justification for the EUA amendments.

Cavazzoni ended both letters with language suggesting the EUAs could change again. "This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.”

In the last week, the Biden administration and the FDA have made changes related to COVID-19 public health policy. Last week, during the FDA VRBPAC meeting, the committee voted to “simplify” COVID-19 vaccine strategy to offer people an annual booster every fall. Earlier this week, the Biden administration made an announcement of the public health emergency being declared over on May 11.

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