FDA Panel Backs Pfizer RSV Vaccine for Older Americans

WEDNESDAY, March 1, 2023 (HealthDay News) -- In a tight vote, U.S. Food and Drug Administration advisers on Tuesday recommended the approval of a respiratory syncytial virus (RSV) vaccine that could be used in Americans ages 60 years and older.

The vaccine, known as RENOIR, was developed by pharmaceutical giant Pfizer Inc. The same panel of advisers will weigh the potential approval of an RSV vaccine from GlaxoSmithKline (GSK) on Wednesday.

If the FDA follows the recommendation of its advisers, which it typically does, the Pfizer vaccine would be the first shot to guard against RSV infection, NBC News reported. The U.S. Centers for Disease Control and Prevention would also need to recommend the single shot before it could become available to Americans.

Still, the FDA advisers were divided in their recommendation. The panel voted 7-4, with one abstention, to recommend approval of the vaccine based on its efficacy, NBC News reported. FDA advisers were also split, 7-4 with one abstention, on the safety of the Pfizer vaccine. The vaccine's potential association with Guillain-Barré syndrome was a concern for those who voted against approval.

Common side effects of both the Pfizer and the GSK vaccines were injection-site and muscle pain and fatigue. Pfizer participants reported headaches, while the GSK participants reported more frequent side effects, according to NBC News.

Pfizer has reported that its vaccine would reduce risk from RSV by as much as 86 percent. The GSK vaccine would lower the risk for symptomatic illness by 83 percent and for severe illness by 94 percent in adults ages 60 years and older, according to trial data that was published in February in the New England Journal of Medicine.

These may not be the only RSV vaccines to come, as 11 are being studied in U.S. trials now, according to data from nonprofit global health organization PATH, NBC News reported. Those include vaccines from Moderna and Bavarian Nordic. Pfizer has also tested its RSV vaccine in pregnant women. An FDA decision on that is expected in August. That vaccine reduced the risk for severe illness in infants by 82 percent through the first 90 days of life. A monoclonal antibody injection designed for babies is also under FDA review. That shot is from Sanofi and AstraZeneca and has already been approved in Europe, NBC News reported.

NBC News Article