Hostage Crisis Ends On Day 73 —American Patients Now Have Access to One Antiviral Pill

Jeffrey A. SingerEarlier this week I  wrote about foot ‐​dragging by the Food and Drug Administration regarding approval of two highly effective antiviral pills. With the omicron variant of COVID-19 rapidly spreading throughout the population, infecting both vaccinated and unvaccinated, these pills becomes even more important.Merck applied to the FDA for Emergency Use Authorization (EUA) of its antiviral molnupiravir on October 11, 2021 —73 days ago. The drug was approved for emergency use in the U.K. on November 4. It is 30 percent effective in preventing COVID infections (including the omicron variant) from progressing to hospitalization, and no patient receiving molnupiravir died from infection. On November 30 an FDA advisory committee recommended its approval. As of this writing the FDA has not acted on the advice of the committee.On November 16 Pfizer sought an EUA for its drug Paxlovid. The drug is 89 percent effective in stopping infections from progressing to hospitalization. Nobody receiving Paxlovid in clinical trials died from COVID. As of yesterday, the FDA had not even called a  meeting of its advisory committee to look at the trial data.Today the FDA finally acted. Itgranted Emergency Use Authorization to Pfizer ’s Paxlovid without even waiting for an opinion from its advisory committee. The FDA director of its Center for Drug Evaluation and Research, Patrizia Cavazzoni, MD, stated:This authorization provides a  new tool to combat COVID-19 at a cruc...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs