A Food and Drug Administration (FDA) panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy. The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end. The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier.
Source: The Hindu December 01, 2021 07:28 UTC