FDA Finally Gets Around to Approving Pfizer's Anti-COVID Pill

It's another case of bureaucratic incompetence as the omicron wave surges.


The U.S. Food and Drug Administration (FDA) announced today that it has finally gotten around to issuing an emergency use authorization (EUA) for Pfizer's oral antiviral medication Paxlovid for the treatment of COVID-19.

Pfizer reported earlier this month that its clinical trial found that the medication "reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo; no deaths compared to placebo in non-hospitalized, high-risk adults with COVID-19." Paxlovid is a combination of the ritonavir protease HIV inhibitor and a new protease inhibitor that targets a specific enzyme that the coronavirus, including the omicron variant, needs to replicate and grow.

The FDA waited to issue an EUA until now, despite the fact that in early November, Pfizer stopped enrolling participants in its clinical trial because the treatment was so effective that it would have been unethical to give new participants a placebo. In the meantime, diagnosed COVID-19 cases grew by another 5 million and 50,000 Americans died of the illness.

The pills should only be taken by adults and children over age 12 and up who test positive for COVID-19 and are at high risk for progression to severe disease, including hospitalization or death. Treatment should be initiated as soon as possible after a COVID-19 diagnosis and within five days of symptom onset. Of course, the FDA's massive screw-up in delaying its approval of rapid at-home COVID-19 tests compounds the problem because many people will find it difficult to access the tests in time to let them know that they could benefit from taking Pfizer's pills.

Four weeks ago, the Biden administration paid Pfizer $5 billion for 10 million courses of the Paxlovid treatment. However, The New York Times is reporting that Pfizer is expected to deliver only enough of its pills to cover 65,000 Americans within the next week. As the Times notes, that is only sufficient at current infection rates to treat half of the people in the U.S. who test positive for the virus. Pfizer will be able to supply 200,000 courses of the treatment in January and 150,000 more in February. Still, every little bit helps.