Pfizer’s new COVID-19 pill is coming.
Or is it?
Let’s break down the big news.
First, today’s announcement was significant. According to the drugmaker, its Phase 2/3 study found that taking its new oral antiviral treatment reduced the risk of hospitalization or death by 89% when taken within three days of experiencing symptoms versus the placebo, and 88% within five days.
This doesn’t mean you can pick up Paxlovid at your local drug store just yet.
Pfizer said this morning that it has shared its study results with the U.S. Food and Drug Administration (FDA) as part of its ongoing submission for what the industry calls emergency use authorization.
Paxlovid isn’t the only pill of this kind. In late November, an FDA advisory committee voted to recommend an emergency use authorization of Merck’s molnupiravir.
“This underscores the treatment candidate’s potential to save the lives of patients around the world,” Pfizer chairman and CEO Albert Bourla said in a written statement. “Emerging variants of concern, like omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic.”
The time line from here remains unclear. According to NBC News, the FDA has yet to schedule an advisory committee meeting to review the application. According to Pfizer, the full data for the study is expected to be released sometime this month and will be submitted for peer review.