The FDA announces Removing Positive COIVD-19 Test Requirements for Paxlovid and Lagevrio EUAs

The Emergency Use Authorization (EUA) allows the FDA to strengthen the nation’s public health protection against chemical, biological, radiological, and nuclear (CBRN) threats. Including infectious diseases by aiding the availability and use of medical countermeasures (MCMs) that may be needed during public health emergencies.

The FDA revised the Letter of Authorization for two EUAS: Paxlovid and Lagervrio.

Paxlovid: treatment of mild to moderate COVID-19 in people 12 years of age and older, weighing at least 40kg, and who are also at high risk for progression to severe COVID-19, including hospitalization or death.

Lagevrio: treatment of mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Furthermore, for those for whom other COVID-19 FDA-approved treatment options are not accessible or clinically proven.

The FDA is removing the requirement for positive test results to prescribe these two prescriptions. The FDA recommends that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19.

“This removal of the positive COVID-19 test will allow many more patients to get the care they need. This allows the healthcare provider more options when they deem it necessary to provide these products,” – Saba Ansari, VP of Clinical Services.