FDA May Authorize Pfizer and Merck Pills This Week

The U.S. Food and Drug Administration (FDA) may authorize 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 sick.

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

The Pfizer pill, Paxlovid, and the molnupiravir from Merck, are intended for higher-risk individuals 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 hospitals as winter infections are expected to rise in the United States.

Spokesmen for the White House and the FDA declined to comment.

“It is the most important thing that can happen in the pandemic after vaccines“, He 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 drugs, he said.

The United States Government ordered 10 million complete treatments of the pill Pfizer and about 3 million doses of the Merck, which is not as effective, clinical studies indicate, and may carry risks.

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