U.S. expert panel backs Pfizer’s RSV vaccine for older adults – CBC

Pfizer, GSK shots could be first approved vaccines for virus, which kills 100,000 people each year

Feb 28, 2023

A panel of outside advisers to the U.S. health regulator on Tuesday recommended Pfizer’s respiratory syncytial virus (RSV) vaccine, bringing it closer to becoming one of the first approved RSV shots for older adults in the United States.

The U.S. Food and Drug Administration’s (FDA) advisory committee voted 7-4 in favour of the vaccine, saying data from the company’s study established that the shot was effective and safe in preventing lower respiratory tract disease caused by RSV in those aged 60 years and older. One member abstained during voting.

GSK, another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts on Wednesday.

While panellists backed Pfizer’s vaccine, concerns were voiced over insufficient efficacy data in the company’s study for adults aged 80 and above, who need the vaccine the most, and suggested a need for detailed post-marketing safety surveillance to address the issue of any serious adverse event.

“The population where the vaccine is going to potentially have the biggest impact is less represented in this study,” said Hana Sahly, one of the 12 FDA panellists.

Read more: https://www.cbc.ca/news/health/rsv-vaccine-fda-1.6763094

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