{"id":1139,"date":"2021-12-15T20:02:00","date_gmt":"2021-12-16T01:02:00","guid":{"rendered":"https:\/\/paragoninstitute.org\/index.php\/2021\/12\/15\/covid-19-treatments-and-the-fda-a-sense-of-urgency-might-help-2\/"},"modified":"2024-04-19T16:00:35","modified_gmt":"2024-04-19T20:00:35","slug":"covid-19-treatments-and-the-fda-a-sense-of-urgency-might-help","status":"publish","type":"post","link":"https:\/\/paragoninstitute.org\/public-health\/covid-19-treatments-and-the-fda-a-sense-of-urgency-might-help\/","title":{"rendered":"Covid-19 Treatments and the FDA: A Sense of Urgency Might Help"},"content":{"rendered":"\r\n
AS\u00a0the Delta variant surges in various locales and the new\u00a0Omicron variant\u00a0expands 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.<\/p>\r\n\r\n\r\n\r\n
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.<\/p>\r\n\r\n\r\n\r\n
If authorized, the pills would enable early Covid-19 to be treated at home with a five-day course of treatment \u2014 a marked improvement upon the treatments that are presently on offer.<\/p>\r\n\r\n\r\n\r\n
The\u00a0only currently FDA-authorized antiviral\u00a0for Covid-19, Remdesivir, must be administered intravenously in a hospital setting, making it burdensome and expensive to use. Monoclonal antibodies \u2014 laboratory-produced molecules that block the virus that causes Covid-19 from attaching to human cells \u2014\u00a0have been granted FDA emergency-use authorizations (EUA), but are costly, difficult to manufacture, and also require intravenous administration.<\/p>\r\n\r\n\r\n\r\n
The most promising of the new oral antivirals is Pfizer\u2019s 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\u00a0applied for an EUA\u00a0a month ago on November 16, 2021.<\/p>\r\n\r\n\r\n\r\n
The company has\u00a0announced\u00a0that a final analysis has confirmed the drug\u2019s 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.<\/p>\r\n\r\n\r\n\r\n