FDA panel narrowly backs Pfizer RSV vaccine for older adults
Federal health advisers have narrowly backed an experimental vaccine from Pfizer that could become the first shot to protect older adults against the respiratory illness known as RSV
WASHINGTON (AP) — Federal health advisers on Tuesday narrowly backed an experimental vaccine from Pfizer that could soon become the first shot to protect older adults against the respiratory illness known as RSV.
The Food and Drug Administration panel voted 7-4 on two separate questions of whether Pfizer's data showed the vaccine was safe and effective against the respiratory virus for people 60 and older. One panelist abstained from voting. The recommendation is non-binding and the FDA will make its own decision on the vaccine in the coming months.
The positive vote came despite concerns about rare potential reactions and questions about how the vaccine fared in people who face the greatest risks from RSV. Pfizer's shot was more than 85% effective at preventing severe disease in a company study, but panelists noted there were few people with underlying health problems.
“I think the primary endpoint was clearly met here,” said Dr. Daniel Feikin, a respiratory disease consultant who voted in favor of the vaccine. “It’s disappointing we don’t have more data on the high-risk groups and severe outcomes.”
