Story at-a-glance
- An advisory panel to the U.S. Food and Drug Administration voted to grant emergency authorization to Merck’s oral COVID-19 pill molnupiravir (Lagevrio) — by a narrow 13-to-10 margin
- Among those who received the drug, the rate of all-cause hospitalization or death was 6.8%, compared to 9.7% in the placebo group — a relative risk reduction of just 30%
- The full data showed more hospital admissions among patients taking molnupiravir (6.2%) than among those taking a placebo (4.7%)
- Molnupiravir works by triggering mutations that ultimately kill the virus; a risk of cancer and birth defects is possible, and the drug shouldn’t be taken by pregnant or breastfeeding women or children
- By driving mutations but not killing off all of the virus — such as if people don’t take the full course of the drug — new and deadlier variants could be unleashed across the globe
- The U.S. government is already on the hook for about 3.1 million courses of molnupiravir, which it bought for approximately $2.2 billion
An advisory panel to the U.S. Food and Drug Administration voted to grant emergency authorization to Merck’s oral COVID-19 pill molnupiravir (Lagevrio) — but only by a narrow margin.1 The 13-to-10 vote speaks volumes about the panel’s confidence in the treatment, as do the numerous concerns regarding efficacy and safety voiced by the panel.