- A panel of outside advisers to the FDA voted unanimously to recommend a half-dose booster shot for some Americans who received Moderna’s COVID-19 vaccine at least six months ago. The advisers recommended that seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19 should get a booster to increase their protection against the virus. The panel will discuss J&J today. Next week, a panel convened by the CDC will offer more specifics on who should get one. (Articles here, here, here, here, here, and here)
- The FDA announced it will ask its outside experts to meet in late November to scrutinize Merck’s pill to treat COVID-19. The delay means U.S. regulators almost certainly won’t issue a decision on the drug until December, signaling that the agency will conduct a detailed review of the experimental treatment’s safety and effectiveness. The panelists are likely to vote on whether Merck’s drug should be approved, though the FDA is not required to follow their advice. (Announcement here; Articles here, here, here, and here)
October 15, 2021
Life Sciences