The FDA Just Authorized Pfizer’s First Covid-19 Pill

It's finally here.
Grant Currin
The FDA's headquarters (left), and a 'COVID-19 Pill' (right).1, 2

Doctors just gained a powerful new tool, just in time for the Omicron wave. 

The U.S. Food and Drug Administration (FDA) issued emergency use authorization for an antiviral pill to treat mild to moderate cases of covid-19, according to a press release from the agency. The move comes after the pill, called Paxlovid, was found to reduce the risk of hospitalization or death from the disease by roughly 89% in a clinical trial.

Paxlovid is an important new therapeutic

The drug will be made available to patients 12 years and older who are at high risk for developing a severe infection, the FDA said in its announcement. Patients who are prescribed the treatment will take 30 pills over five days. The prescription-only medicine should be taken as soon as possible after diagnosis, according to the agency. This is the first anti-viral pill researchers have approved to treat covid-19. The federal government has agreed to pay Pfizer $5.3B for 10 million courses of the treatment, NPR reports

Early research suggests that Paxlovid could dramatically decrease the rate of hospitalization due to covid-19. In one study, roughly 1,400 high-risk, unvaccinated adults were given either Paxlovid or a placebo within the first three days of symptoms. Just five of the nearly 700 patients who received the drug were hospitalized and none died. By contrast, 44 patients in the slightly smaller placebo group ended up in the hospital, and nine eventually died. Sara Cherry, a virologist at the University of Pennsylvania, called these results "quite amazing and potentially transformative,” in an interview with The New York Times.

The new treatment is arriving at a critical moment

The authorization comes as the U.S. braces for a new wave — this one fueled by the Omicron variant — that appears to be building at the same time that millions of Americans are traveling for the holiday season. And it's especially welcome news as evidence mounts that the new variant Omicron is more contagious than previous variants and possibly better at getting past vaccines. At a press conference earlier this month, Pfizer reported the results of a study that suggested people who received a booster of their vaccine had similar protection against Omicron (as measured by levels of neutralizing antibodies) as people with the original two-shot sequence had against the other variants, according to a report from Nature.

Pfizer isn't the only drugmaker that has produced an antiviral pill, but early results indicate that Paxlovid is the most effective antiviral currently available. Last month, regulators in the United Kingdom approved a similar treatment, called molnupiravir, that reduced high-risk patients' chances of hospitalization or death by 50%. A report in Bloomberg, citing confidential sources, says the FDA will approve the treatment later this week. With rich countries scrambling to get their hands on this groundbreaking treatment, a Pfizer spokesperson promised the company would use "a tiered pricing approach based on the income level of each country."

This was a developing story about an important new therapeutic for COVID-19. Information was updated as it became available. 

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