WASHINGTON D.C.: The U.S. Food and Drug Administration (FDA) is expected to approve, within days, Pfizer’s and Merck’s groundbreaking pills to treat COVID-19, sources told Bloomberg News.
Writing in the Guardian, Eric Topol, director of the Scripps Research Translational Institute, said the approval of Pfizer’s Paxlovid and Merck’s Molnupiravir would come at a time “when we absolutely need it,” amidst the surge of the Omicron variant.
“It is a sign of light in a very long tunnel. But its extraordinary promise will not get realized unless we pull out all the stops to quickly get it made and distributed at mass scale,” he added.
Topol told Bloomberg that the unusual late-year timing of the announcement highlighted the urgent need for the treatments.
In clinical trials, Paxlovid performed well, with a nearly 90 percent efficacy in preventing hospitalizations and deaths from Covid among high-risk patients.
In a statement, Albert Bourla, Pfizer’s chief executive, said Paxlovid could be “a critical tool to help quell the pandemic.”
Last month, the UK became the first country in the world to approve Molnupiravir, which is taken twice-daily and is targeted at elderly people and those vulnerable to severe disease.
But cautious U.S. regulators sought independent analysis on the risks of birth defects and other issues in pregnant women, while accepting its reduced efficacy, compared to Paxlovid.
Meanwhile, an FDA advisory panel has recommended approval and emergency use authorization this week, indicating that concerns have been downgraded or eliminated.
Studies showed Molnupiravir reduced the combined risk of hospitalization and death from Covid by 30 percent.
Bloomberg reported that the U.S. government has ordered 10 million courses of Paxlovid and some 3 million of Molnupiravir, but they are not expected to become immediately available.
“We must find a way to rapidly scale pill pack production for wide accessibility and use throughout the world. If we had an unlimited supply of these pills, it could have an extraordinary impact on preventing illness, preserving our healthcare workforce, staving off spread, eliminating the need for lockdowns and school closings,” Topol wrote in the Guardian.
