FDA reportedly could authorize Pfizer, Merck COVID pills this week: 'The biggest thing to happen in the pandemic after vaccines'
The U.S. Food and Drug Admnistration could authorize COVID-19 antiviral pills from both Pfizer and Merck as soon as this week, Bloomberg reports, "a milestone in the fight against the pandemic that will soon expand therapies for the ill."
According to three individuals with knowledge of the matter, an announcement may arrive as early as Wednesday. Both pills — Pfizer's Paxlovid and Merck's molnupiravir — work as an at-home treatment for higher-risk individuals who have tested positive for COVID-19. Regulators and developers hope the anti-virals will "ease the burden on stretched hospitals with infections poised to soar through the winter in the U.S.," Bloomberg reports. In trials, Pfizer's pill "showed an 89 percent reduction in hospitalization for patients who received the medicine within three days of developing symptoms, compared to patients who got a placebo."
"It's the biggest thing to happen in the pandemic after vaccines," Eric Topol, director of the Scripps Research Translational Institute, told Bloomberg, noting that the unusual, late-in-the-year timing of the announcement indicates the urgency with which the FDA is operating. That said, don't expect the pills to be immediately available everywhere.
The federal government has ordered 10 million courses of Paxlovid and about 3 million courses of molnupiravir, which clinical studies have indicated isn't as effective. Last month, an FDA advisory panel "narrowly recommended" the Merck pill for use, as some members were concerned about its safety in pregnant women. Read more at Bloomberg.
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