FDA advisors recommend Pfizer RSV vaccine for older adults, despite possible Guillain-Barre risks

The Food and Drug Administration’s independent advisors on Tuesday recommended Pfizer’s RSV vaccine for adults ages 60 and older, despite safety concerns after two people who received the shot developed a rare neurological disorder. 

Though a majority of the FDA committee members backed the vaccine, they wrestled with two separate votes on whether the safety and efficacy data are adequate to support the agency’s approval. 

In the first vote, seven members of the committee said the safety data was adequate for an approval, while four said it was not, and one member abstained.