A Food and Drug Administration advisory committee voted 16-1 that the benefits of Pfizer’s PFE COVID antiviral Paxlovid outweigh the risks in adults who are at high risk of severe disease. The FDA is not required to follow the advice of the committee but often does. Paxlovid is a medication that first received emergency-use authorization in December 2021. It can be prescribed to teens and adults who are at high risk of progressing to severe disease. “We are encouraged by the AMDAC’s positive vote today,” James Rusnak, chief development officer of the internal medicine, anti-infectives and hospital business at Pfizer, said in a statement. “The outcome is well supported by the strong safety and efficacy data seen both in our clinical trials and in a growing base of real-world evidence.” Pfizer’s stock is down 21.4% so far this year, while the broader S&P 500 SPX is up 1.7%.
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