FDA expected to authorize Pfizer and Merck COVID pills this week

Josh Wingrove, Jennifer Jacobs, and Robert Langreth

The U.S. Food and Drug Administration is poised to authorize a pair of pills from Pfizer Inc. and Merck & Co. to treat Covid-19 as soon as this week, according to people familiar with the matter -- a milestone in the fight against the pandemic that will soon expand therapies for the ill.

An announcement may come as early as Wednesday, according to three of the people. They asked not to be identified ahead of the authorization and cautioned that the plan could change. 

Pfizer’s experimental pill, called Paxlovid, treats COVID-19 and appears effective against the new omicron variant.

Pfizer and Merck pared earlier declines on the news. Merck was trading down 0.7% at 10:43 a.m. in New York, while Pfizer was off 5.1%.

Pfizer’s pill, Paxlovid, and Merck’s molnupiravir are intended for higher-risk people who test positive for Covid. The treatments, in which patients take a series of pills at home over several days, could ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S. 

Spokespeople for the White House and FDA declined to comment. 

“It’s the biggest thing to happen in the pandemic after vaccines,” said Eric Topol, director of the Scripps Research Translational Institute. The timing of the announcement, so late in the year, is unusual for the FDA and reflects the urgency behind the medicines, he said.

This undated file image provided by Merck & Co. shows their new antiviral medication.

FDA’s authorizations may include limitations for populations in which they could be used, one of the people familiar with the matter said. A Food and Drug Administration advisory committee narrowly recommended the Merck pill last month, with some members of the panel citing safety concerns including for pregnant women.

The U.S. government has ordered 10 million courses of the Pfizer pill and about 3 million courses of Merck’s, which isn’t as effective, clinical studies indicate, and may carry risks. However, the pills are likely to not be immediately available in widespread supply.

In a clinical trial, Pfizer’s pill showed an 89% reduction in hospitalization for patients who received the medicine within three days of developing symptoms, compared to patients who got a placebo. None of the patients treated with the drug died. 

Authorization for Pfizer’s pill would represent a vote of confidence in the medicine from regulators, as FDA advisers have not been asked to consider the drug’s clinical evidence.

Merck developed molnupiravir with partner Ridgeback Biotherapeutics LP.

With assistance by Cynthia Koons, and Fiona Rutherford