FDA Issues EUA for Pfizer drug Paxlovid, the First Oral Antiviral Treatment of COVID-19

Posted on December 23, 2021 by Libbie Chapuran

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization for the Pfizer-developed drug Paxlovid, the First Oral Antiviral Treatment of COVID-19.

Paxlovid is the first COVID treatment in pill form. It must be prescribed and can be used for treating mild-to-moderate cases of COVID-19 in both adults and kids 12 years old and older who test positive for COVID-19 and are at high risk for severe COVID. There is a 5-day regimen for the prescription pill for 30 tablets. The treatment is a two-drug regimen delivered in 30 tablets over five days.

The first drug works to prevent the SARS-COV-2 protein from replicating, and the second drug slows the first protein-inhibiting drug from breaking down too quickly, so it stays in the person's system longer to fight off the virus. In the trials, "Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment."

It was tested on a 60-year-old and older population. The treatment is not recommended for individuals with certain conditions – liver and kidney issues – or who take certain medications. Pfizer has said it is "ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible." In November, it announced an agreement with the U.S. government to supply 10 million treatment courses of PAXLOVID, with delivery fulfillment expected to be completed in 2022.

It is unknown what the drug will cost and if it will be covered by Medicare, Medicaid and managed care plans. For further information on this EUA, FDA provides these FAQs.