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.
In the second vote, seven members said the effectiveness data was adequate, while four said it was not, and one member abstained.
The vote followed concerns at the FDA and among advisory committee members about two cases of Guillain-Barre syndrome among about 20,000 vaccine recipients. Guillain-Barre is a rare neurological disorder in which the body’s immune system mistakenly attacks the nerves.
Symptoms can range from brief weakness to paralysis. Most patients, even those with severe cases, recover.
The FDA considers the cases to be possibly linked to the vaccine, said Dr. Nadine Peart Akindele, an agency official. The FDA has asked Pfizer to conduct a safety study on Guillain-Barre syndrome, which the company has agreed to do.
NewsBreak: FDA says Guillain-Barre syndrome is possible risk of Pfizer’s RSV vaccine for older adults (Abomination Shot Adverse Event)
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