November 26, 2021
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0:46Now PlayingHealth officials say Merck’s experimental Covid pill is effective against the virus but questions around the risk of usage during pregnancy remain.
Merck & Co. shares sank after new data showed its Covid-19 pill was less effective than previously reported and U.S. regulators raised concerns about its safety and long-term effectiveness.
Merck’s latest trial results, reported Friday from a larger population than its initial study, show that its pill reduced the risk of hospitalization or death among adults with mild to moderate disease by 30%. That was less than a previous estimate of 48%.
Staff at the Food and Drug Administration, meanwhile, called the pill, molnupiravir, effective for individuals at increased risk for severe disease. But they raised questions about whether the treatment could cause birth defects, as well as bone and cartilage toxicity and genetic mutations. The staff also cited possible resistance to the drug, which occurs when viruses and bacteria evolve to blunt or defeat a drug’s mechanism of attack.
The documents published Friday by the FDA are meant to spur discussion in a meeting next week of advisers to the agency, which will then determine whether to authorize molnupiravir for emergency use.
The news comes after the discovery of a new coronavirus variant in South Africa, described by scientists as very different from previous incarnations and of serious concern.
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