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 ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice.
The drugmaker said the experimental pill, molnupiravir, was shown to be 30 per cent effective in fighting hospitalisations and deaths in a study of 1433 patients. That’s a drop from a 50 per cent effectiveness rate in a prior study of 775 patients, the NY Post reported, whereas a Pfizer Covid-19 pill showed an 89 per cent efficacy rate among 1200 patients who took the drug, paxlovid.
The regulator has said molnupiravir is effective in combating serious Covid-19 illness and death, but that they want to vet it for birth defect and pregnancy risks.
FDA scientists said their review identified several possible risks, including toxicity to developing foetuses and birth defects that were identified in studies of the pill in animals, the Associated Press reported.
The FDA also highlighted a concern that the Merck pill created small changes in the virus’ spike protein, which in theory could lead to dangerous new variants. The FDA have confirmed that Merck agreed not to make the pill available to children.
