Merck Antiviral Drug Moves Closer to Approval

Jeffrey A. SingerA Food and Drug Administration Advisory Panel justapproved, narrowly, the Merck antiviral drug Molnupiravir. This is just step one. We now have to wait for the FDA to decide on emergency use authorization.The U.K. approved Molnupiravir on November 4.Merck applied to the FDA for approval on October 11. Vaccines are the best long ‐​term defense against COVID-19, but antivirals are the best first‐​line defense, especially when new variants can develop that escape the immunity provided by vaccines.Rather than wait weeks for the vaccine to take effect, antivirals —like antibiotics—work immediately to kill the pathogen.The FDA ’s bureaucratic foot‐​dragging must stop, especially with politicians considering reinstating lockdowns and bans on elective procedures.Pfizer submitted its antiviral, Paxlovid, to the FDA on November 20. Let ’s hope the FDA is quicker on Paxlovid—especially since the clinical trials were so impressive that, for ethical reasons, Pfizer interrupted the trial and immediately sought emergency use authorization.
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