An advisory committee to the Centers for Disease Control and Prevention (CDC) voted 9-5 to recommend two newly approved RSV vaccines for adults ages 65 and up from Pfizer and GSK.
The vaccines are intended to protect against respiratory syncytial virus, which can cause pneumonia or bronchiolitis. Older people are particularly vulnerable to severe outcomes, with RSV killing up to 10,000 people ages 65 or older every year in the U.S. Pfizer's and GSK's shots are the only RSV vaccines approved by the Food and Drug Administration, but neither is publicly available yet.
Dr. Rochelle Walensky, the CDC's director, is expected to formally endorse the vaccines soon. However, the shots might be difficult to find right away. GSK aims to make its RSV vaccine available in the fall so older adults have protection heading into the next RSV season, which typically peaks in the winter
Walgreens and CVS Pharmacy plan to offer RSV vaccines at their locations across the country in time for the next respiratory illness season. Appointments can be made online, over the phone, or through the Walgreens app once vaccines are available.
The FDA approved GSK's RSV vaccine, Arexvy, based on a late-stage clinical trial that showed a single dose lowered the risk of symptomatic illness by 83% and of severe illness by 94%. Pfizer's single-dose vaccine, Abrysvo, was approved based on a similar trial in which it reduced the risk of symptomatic illness by as much as 86%. Protection waned slightly by around 18 months after vaccination, though it was still as high as 79%.
Both Pfizer's and GSK's vaccines produced mild side effects in some recipients, including injection site pain, fatigue, and muscle pain.
The FDA identified one case of Guillain-Barré syndrome and one case of Miller Fisher syndrome related to Pfizer's vaccine. The FDA also identified one case of Guillain-Barré that was potentially related to GSK's vaccine, as well as a higher number of incidences of atrial fibrillation among vaccine recipients relative to the trial's control group.
Some members of the CDC advisory committee expressed concern about price, with GSK's vaccine costing $200 to $295 per dose and Pfizer's vaccine costing $180 to $270 per dose. Two tools to protect babies from RSV could become available before the fall: Pfizer's maternal RSV vaccine, which is given to pregnant mothers to protect their infants from RSV, and an injectable drug called nirsevimab, which can protect infants up to 2 years old from RSV.
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