FDA advisors recommend agency approve Pfizer RSV vaccine despite safety concerns

A panel of advisers for the U.S. Food and Drug Administration on Tuesday recommended approving the use of a Pfizer-made RSV vaccine for adults aged 60 and older.

Vaccines and Related Biological Products Advisory Committee backed the vaccine in a 7-4 vote, with one member abstaining, NBC News reported. The vote from the independent body is merely a recommendation that the FDA approve the vaccine, a process that will likely take some time.

Should the FDA do so, the Centers for Disease Control and Prevention would then be able to sign off on the vaccine for public use, meaning the Pfizer product would become the nation's first inoculation against respiratory syncytial virus.

Pfizer asserted that its single-dose vaccine boasted an 85.7% efficacy rate in those with with severe RSV. 

"Respiratory syncytial virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms," the CDC states. "Most people recover in a week or two, but RSV can be serious, especially for infants and older adults."

The panel also held a second vote on the vaccine's safety, which saw the same outcome. Those panel members who opposed approval of the Pfizer shot were concerned about the relatively small size of Pfizer's trial and had reservations over potential links to Guillain-Barré syndrome (GBS).

Committee Chair Dr. Hana El Sahly opposed approval of the Pfizer product, saying "It was a 1 in 9,000 risk of GBS, which is concerning."

Ben Whedon is an editor and reporter for Just the News. Follow him on Twitter.