FDA: Merck COVID pill effective

Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy.

The Food and Drug Administration posted its analysis of the pill before a public meeting next week where academic and other experts will weigh in on its safety and effectiveness.

The FDA scientists said their review identified several potential risks, including possible toxicity and birth defects. Given those risks the FDA will ask its advisers whether the drug should never be given during pregnancy.

Given the safety concerns, FDA said Merck agreed the drug would not be used in children.

Additionally, the FDA flagged a concern that Merck’s drug led to small changes in the coronavirus’ signature spike protein, which it uses to penetrate human cells. Theoretically, FDA cautioned, those changes could lead to dangerous new variants. Regulators also noted Merck collected far less safety data overall than was gathered for other COVID-19 therapies.

FDA will ask its independent advisers to discuss all those issues and then vote on whether the drug’s overall benefits outweigh its risks.

All COVID-19 drugs currently authorized by the FDA require an injection or IV and can only be given by health professionals. If authorized, Merck’s drug would be the first that U.S. patients could take at home to ease symptoms and speed recovery. It is already authorized for emergency use in the U.K.

The drug, molnupiravir, has been shown to significantly cut the rate of hospitalizations and deaths among people with mild-to-moderate coronavirus infections. Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny mutations into the coronavirus’ genetic code to the point that it can’t reproduce itself.

But that genetic effect has raised concerns that in rare cases the drug could cause birth defects or tumors. Pregnant women were excluded from Merck’s study.