The pharmaceutical company Merck on Friday released new numbers on the effectiveness of molnupiravir, a pill that interim results in October indicated might cut coronavirus hospitalizations and deaths by half. The updated findings, based on nearly double the number of study participants, lowers the efficacy rate to 30 percent.
The Food and Drug Administration (FDA) posted an analysis on Friday ahead of an advisory committee meeting on Tuesday. The agency said the pill appears to be effective, but it wants outside experts to address pregnancy and birth defect risks.
According to the FDA, Merck agreed not to provide molnupiravir to children over safety concerns.
What are the concerns? Molnupiravir inserts genetic mutations into the COVID-19 virus’s DNA to prevent it from reproducing. Federal regulators worried this could lead to stronger virus variants in the future.
Merck’s study also did not include any pregnant women. The FDA analysis noted several potential risks, including birth defects in studies of the pill on animals.
The agency also said Merck collected less safety data than researchers had for other COVID-19 therapies. The advisory committee will review the research and decide whether to recommend Merck’s pill and whether or not to recommend it specifically for pregnant women.
The committee’s decision is not binding on the agency.
This story originally appeared in WORLD. © 2021, reprinted with permission. All rights reserved.