The Food and Drug Administration on Wednesday authorized Pfizer’s antiviral pill for the treatment of individuals at high risk of severe illness from COVID-19.
Why it matters: At-home COVID-19 treatments, especially Pfizer’s Paxlovid, are seen as possible game-changers for the pandemic. The emergency use authorization comes as the U.S. sees a surge in new COVID-19 cases and hospitalizations largely driven by the Omicron variant.
Driving the news: Pfizer released new data last week confirming Paxlovid reduced the risk of hospitalization or death by 89% in high-risk adults, Axios’ Tina Reed reports.
- An interim analysis of a second study of the pill that has so far shown a 70% reduction in hospitalization among standard-risk adults, Pfizer said.
- Pfizer also believes the Paxlovid treatment will work well against the Omicron variant because of the way the drug works.
What they’re saying: «Today’s authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world,» Pfizer chairman and CEO Albert Bourla said in a statement.
- «This breakthrough therapy … will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,» he added.
Between the lines: The pill is most effective when given early in the course of an infection, underscoring the importance of inexpensive, easily accessible COVID-19 tests, including at-home rapid versions, Axios’ Bryan Walsh writes.
- President Biden on Tuesday said that his administration will make 500 million at-home COVID-19 tests available for free, starting next month.
The big picture: The federal government has ordered enough of Paxlovid to treat 10 million Americans, Biden said last week.
- The FDA is also considering whether to authorize Merck and Ridgeback Biotherapeutics’ antiviral COVID-19 pill, known as molnupiravir.
- Merck said last month that molnupiravir reduced the risk of hospitalization or death for patients with mild or moderate COVID-19 by about 30%, based on a study of more than 1,400 adults.
- Molnupiravir won a narrow backing from an FDA advisory panel last month, with some expressing concerns over the drug’s effectiveness and safety.
