The U.S. Food and Drug Administration on Wednesday approved the emergency use of Pfizer’s new antiviral pill Paxlovid in people who are at high risk for severe COVID-19. It’s the first approved treatment for COVID-19 meant to be taken at home.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in an agency news release. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge.”
Pfizer first asked for emergency authorization in mid-November, and later announced stunning final trial results on the power of Paxlovid to guard against severe COVID-19. In that trial, the pill, taken for five days, slashed a person’s odds for hospitalization and death by nearly 90% in high-risk people. Paxlovid should be taken within three to five days of symptom onset, the FDA said.
“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 company statement. “This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our health care and hospital systems.”
One infectious diseases expert welcomed the news.
How will an oral pill help?
“Paxlovid’s approval is a major milestone that marks another step towards making COVID-19 a much more manageable infection,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, in Baltimore. “An oral pill that can cut hospitalizations and deaths by 90% is pathbreaking. There are two key issues, however, that remain: it will be scarce in the coming weeks, and its optimal use requires prompt diagnosis, which can be difficult with the continual testing problems that plague us.”
At the time of the trial results, Bourla stressed the importance of adding another weapon to the COVID-fighting arsenal.
“This news provides further corroboration that our oral antiviral candidate, if authorized or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of Paxlovid in reducing hospitalization and death, and show a substantial decrease in