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.