From WSJopinion: The early data indicate that molnupiravir is the greatest scientific advancement against Covid since the vaccines. Will the FDA act to save lives today? asks MartyMakary
With the stroke of a pen, the Food and Drug Administration could save thousands of Covid patients’ lives. Data released last week showed that the new antiviral pill molnupiravir, made by Merck and Ridgeback Biotherapeutics, is safe and reduces the risk of the direst outcomes by 50%. It works by directly blocking replication of the virus, is effective against variants, and can be used in combination with other Covid therapies.
The FDA’s emergency-use authorization can take months. But the FDA could allow compassionate use of molnupiravir now by activating what is known as an expanded-access protocol, ahead of the drug’s formal evaluation. There is a precedent. Last year, the FDA activated the protocol for convalescent plasma months before it issued a formal EUA. The agency also allowed monoclonal antibodies to be given to President Trump and other officials last year before that therapy was granted a formal EUA.
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