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Covid-19 Treatments and the FDA: A Sense of Urgency Might Help

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Director at Public Health and American Well-Being Initiative
Joel M. Zinberg, M.D., J.D. is the Director of the Public Health and American Well-Being Initiative at Paragon Health Institute, and a senior fellow with the Competitive Enterprise Institute. A native New Yorker, he recently completed two years as General Counsel and Senior Economist at the Council of Economic Advisers in the Executive Office of the President.

AS the Delta variant surges in various locales and the new Omicron variant expands around the globe, public officials are beginning to reimpose Covid-19 restrictions. The Food and Drug Administration, though, seems to lack the same sense of urgency.

The agency is considering two new antiviral pills that have been found to cut Covid-19 hospitalizations and deaths in people treated soon after they become symptomatic.

If authorized, the pills would enable early Covid-19 to be treated at home with a five-day course of treatment — a marked improvement upon the treatments that are presently on offer.

The only currently FDA-authorized antiviral for Covid-19, Remdesivir, must be administered intravenously in a hospital setting, making it burdensome and expensive to use. Monoclonal antibodies — laboratory-produced molecules that block the virus that causes Covid-19 from attaching to human cells — have been granted FDA emergency-use authorizations (EUA), but are costly, difficult to manufacture, and also require intravenous administration.

The most promising of the new oral antivirals is Pfizer’s Paxlovid. The company halted a trial of the drug when an interim analysis demonstrated an 89 percent reduction in risk of hospitalization or death compared with placebo in nonhospitalized high-risk adults with Covid-19. Pfizer applied for an EUA a month ago on November 16, 2021.

The company has announced that a final analysis has confirmed the drug’s high effectiveness with the added bonus that it appears to be effective against Omicron. A second clinical trial in low-risk, unvaccinated people, as well as in vaccinated people at high risk for Covid-19 complications, found that Paxlovid cut hospitalizations by 70 percent compared with placebo. Yet the FDA has still not scheduled a meeting of its advisory committee to review the Paxlovid EUA.

Read the full article in National Review.

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