Many Americans have been looking for more treatments for COVID-19, and now the FDA has authorized Pfizer’s COVID treatment pill, Paxlovid, under emergency use authorization. Paxlovid will soon be available for adults and children over 12 who exhibit mild cases of COVID along with a positive test. A doctor must prescribe the pill within five days of the onset of symptoms.
This makes Paxlovid the first at-home treatment for COVID, and it’s not meant for prevention of the virus.
“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 Patrizia Cavazzoni, M.D., 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.”
Clinical trials demonstrated that Paxlovid decreased the risk of hospitalization or death by 89%, which is an impressive track record.
The FDA also makes it clear that an emergency use authorization stops short of full approval:
The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of scientific evidence available and carefully balances any known or potential risks with any known or potential benefits of the product. Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Paxlovid may be effective for the treatment of mild-to-moderate COVID-19 in authorized patients.
Pfizer has announced that it will begin delivery of Paxlovid immediately, with 180,000 treatment courses available by the end of the year (which is next week) and up to 80 million doses next year. The Biden administration announced earlier this month that it would purchase 10 million of those courses of treatment.
You may remember last month that Merck’s highly touted treatment called molnupiravir turned out not to be as effective as the company initially promised. The disappointing news from Merck makes the FDA’s authorization of Paxlovid even more impressive.
Is this new pill a game-changer? Certainly, but there are other options that are available.
Meanwhile, the antimalarial drug hydroxychloroquine, which is out-of-patent and cheap to make, goes absurdly underused in the fight against COVID. There have been nearly 300 studies into hydroxychloroquine’s effectiveness in treating COVID-19—the overwhelming majority of which show positive results—including a large-scale study published in July conducted by the Henry Ford Health System that found a 50% reduction in mortality in patients who took hydroxychloroquine.
Paxlovid is a breakthrough, and as the pandemic hopefully nears its end, this treatment will help people who get the virus fight it off quickly and effectively.