FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concerns

The Food and Drug Administration’s independent panel of advisors on Thursday recommended full approval of Pfizer’s vaccine that protects infants from RSV, but raised safety concerns over premature births that may be tied to the shot. 

The committee unanimously said the vaccine efficacy data was sufficient. Ten of the advisors said the safety data on Pfizer’s shot was adequate, while four said it was not.

“If the vaccine actually lives up to the data that we’ve seen today, I can guarantee that many infants and their parents will breathe easier in the coming years,” said Dr. Jay Portnoy, medical director at the Children’s Mercy Hospital in Kansas City, after voting in favor of the safety and efficacy of the shot.

Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, said he doesn’t believe there is enough data that indicates the safety of the vaccine is “reassuring.” 

“If you’re in any sense risking premature births with this vaccine, I think there’ll be a big price to pay,” said Offit, who voted against the shot’s safety data. 

Adam Berger, the director of clinical and healthcare research policy at the National Institutes of Health, voted in favor of the shot’s safety and efficacy but said Pfizer’s post-marketing studies need to examine the risk of premature births.

Post-marketing refers to studies conducted on a product after it receives FDA approval.

The FDA typically follows the advice of its advisory committees but is not required to do so. The agency is slated to make a final decision on the shot in August, right before respiratory syncytial virus season in the fall. 

If approved, Pfizer’s jab would become the world’s first vaccine that protects infants against RSV – a goal scientists have been working toward for decades.

The FDA earlier this month approved the first RSV shot for adults ages 60 and older from GlaxoSmithKline. The agency is expected…