FDA gives emergency authorization to Pfizer’s COVID-19 pill

COVID-19 patients as young as 12 are eligible for enzyme-inhibiting treatment.

Eric Bangeman – Dec 22, 2021 6:01 PM | 207

COVID-19 patients as young as 12 can now be treated with Paxlovid, an antiviral pill developed by Pfizer, after the Food and Drug Administration issued an emergency use authorization on Wednesday.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally—a major step forward in the fight against this global pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

In early November, Pfizer published trial results for the new oral medication, saying that it reduced hospitalizations and deaths due to COVID-19 by 89 percent. Although the results had not undergone peer-review, Paxlovid's strong effectiveness moved an independent data-monitoring committee to recommend ending the trial early.

Ars Video

Paxlovid is the second COVID-19 pill to be developed, with Merck publishing Phase III results for its oral COVID-19 treatment, Molnupiravir, at the beginning of October. While initial results showed a 50 percent reduction in the risk of hospitalization and death from COVID-19, further analysis pegged Molnupiravir as just 30 percent effective. Despite the disappointing results, the FDA approved an emergency use authorization for it in late November by a 13-10 vote.

Development on what became Paxlovid began after the SARS outbreak of 2002. It works by hindering an enzyme called a proteasee, which is found in many coronaviruses, including SARS-CoV-2. Inhibiting this enzyme prevents the virus from replicating inside the body.

Paxlovid has also been approved by the Committee for Medicinal Products for Human Use of the European Medicines Agency for treating non-severe cases of COVID-19.

The newly approved medication will be in short supply for now, as Pfizer says fewer than 200,000 doses will have been made available by the end of the year. With the help of contract manufacturers, an additional 120 million doses should be produced by the end of 2022.

The FDA stresses that Paxlovid isn't designed to prevent infection after exposure, and it's not indicated for severe cases requiring hospitalization. In fact, the agency makes it clear that it is "not a substitute" for vaccination. But with omicron raging across the country (and around the world), doctors now have another tool for treating COVID-19.

Ars Video

nproxy.org