COVID-19 Antiviral Access Expedited
The leading antiviral treatments for a person with either a SARS-CoV-2 coronavirus infection or the disease it causes, COVID-19, became more accessible today.
The U.S. Food and Drug Administration (FDA) notified Pfizer Inc. and Merck Sharp & Dohme LLC on February 1, 2023, it has issued revised emergency Use Authorization (EAU) #105 and #108.
Patrizia Cavazzoni, M.D. Director Center for Drug Evaluation and Research U.S. FDA wrote, 'having concluded that revising this EUA is appropriate to protect the public health or safety under Section 564(g)(2) of the Act, FDA is reissuing the October 27, 2022 letter in its entirety.'
The scope of authorization no longer requires positive results of direct SARS-CoV-2 coronavirus viral testing.
As revised, the scope of authorization now requires, in addition to other requirements, that adults and pediatric patients (12 years of age and older, weighing at least 40 kg) have a current diagnosis of mild-to-moderate COVID-19.
This indicates PAXLOVID™ may be prescribed for an individual patient by physicians, advanced practice registered nurses, physician assistants, and specific pharmacy staff that are licensed or authorized under state law to prescribe drugs.
Based on the totality of scientific evidence available to the FDA, including data from the clinical trial EPIC-HR, a Phase 2/3 randomized, double-blind, placebo-controlled clinical trial, it is reasonable to believe that PAXLOVID may be effective for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death, as described in the Scope of Authorization.
And when used under the conditions described in this authorization, the known and potential benefits of PAXLOVID outweigh the known and potential risks of such a product.
However, PAXLOVID is not authorized to initiate treatment in patients requiring hospitalization due to severe or critical COVID-19; is not authorized for use as pre-exposure or post-exposure prophylaxis to prevent COVID-19; and is not authorized for use for longer than five consecutive days.
Previously, Pfizer announced it expects to sell fewer PAXLOVID doses in 2023. On January 31, 2023, Pfizer stated it expects a 58% revenue reduction.
Conditions in this letter have also been revised based on completing a post-authorization requirement. The unedited EAUs are linked here: #105 and #108.