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

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.

Pharmaceutical companies Merck and Ridgeback Biotherapeutics announced that their investigational oral antiviral drug Molnupiravir reduced the risk of hospitalization or death by about 50 percent compared with placebo for patients with mild or moderate Covid-19 back on October 1, 2021. A phase III study of the drug was stopped early, when an independent monitoring board concluded the drug was so effective that it would be unethical to continue giving a placebo.

The drug was found to be safe and effective and approved for use in the United Kingdom on November 4. A few days later, Bangladesh authorized four companies to manufacture and distribute generic versions of the drug. By November 19, the European Medicines Agency advised national authorities considering authorization that Molnupiravir could be used to treat adults with Covid-19 who are at increased risk of developing severe Covid-19.

While Merck and Ridgeback applied to the FDA for an EUA on October 11, the FDA delayed consideration for more than six weeks, deciding to take the extraordinary step of convening an outside expert advisory committee on November 30.

By the time the committee met, a final analysis of the data showed that Molnupiravir decreased the risk of Covid-19 complications by 30 percent — down from the original 50 percent figure in the interim analysis. Nevertheless, the committee narrowly voted to recommend granting the drug emergency authorization by a vote of 13 to ten. The FDA has yet to authorize the pill.

Side effects for both new pills were similar in people who received the study medicines or the placebo and were mostly mild. There are no known serious safety concerns for Paxlovid.

Read the full article at National Review.