Adults ages 65 and up should get one of the newly approved RSV vaccines, an advisory committee to the Centers for Disease Control and Prevention decided Wednesday.
The committee voted 9-5 to recommend two different RSV vaccines for adults ages 65 and up, from the pharmaceutical giants Pfizer and GSK. Thirteen members also voted to recommend the shots for adults ages 60 to 64 based on individual risk levels and in consultation with doctors, with one committee member abstaining.
Respiratory syncytial virus causes a lower respiratory illness that is generally mild for most healthy adults. But in serious cases, RSV can lead to pneumonia or bronchiolitis, which inflames airways and clogs them with mucus.
Older people are particularly vulnerable to severe outcomes: RSV kills 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. The FDA approved each shot for adults ages 60 and up last month, but as with any new vaccine, the CDC must recommend the shots before they can be distributed or administered.
Following Wednesday’s vote, the final step is for the CDC’s director, Dr. Rochelle Walensky, to formally endorse the vaccines, which she is expected to do soon.
Even after that, the shots might be difficult to find right away. Dr. Phil Dormitzer, GSK’s senior vice president and global head of vaccines research and development, said last month that the company 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 said it expects to offer the new vaccines at pharmacies 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 company said. CVS Pharmacy said it will also work with vaccine manufacturers to ensure access to RSV shots at more than 9,000 locations.
The FDA approved GSK’s RSV vaccine, called Arexvy, based on the results of a late-stage clinical trial that showed that 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%. More recent data presented Wednesday to the CDC showed that protection waned slightly by around 18 months after vaccination, though it was still as high as 79%.
Both vaccines produced mild side effects in some recipients, including injection site pain, fatigue and muscle pain.
In evaluating the safety of Pfizer’s vaccine, the FDA identified one case of Guillain-Barré syndrome, a rare neurological disorder, and one case of Miller Fisher syndrome, a rare nerve disease related to Guillain-Barré.
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 (irregular heart rhythm) among vaccine recipients relative to the trial’s control group.
Some members of the CDC advisory committee emphasized a lack of data Wednesday about how well immunocompromised people, those with underlying health issues and people over age 75 would tolerate the vaccines and pointed to limited evidence about whether second doses would boost protection.
Members also expressed concern about price. GSK said a single dose would cost $200 to $295, and Pfizer estimated that a single dose would cost $180 to $270. (Those prices, though, do not reflect what insured patients would pay.)
In addition to older adults, RSV can pose a major health threat to infants. But two tools to protect babies from the virus could become available before the fall, as well.
An independent advisory committee to the FDA voted last month to recommend Pfizer’s maternal RSV vaccine, which is given to pregnant mothers to protect their infants from RSV. The vaccine is the same formulation as Pfizer’s shot for older adults.
The FDA advisory panel this month also recommended an injectable drug that can protect infants up to 2 years old from RSV. The pharmaceutical giant AstraZeneca developed the monoclonal antibody drug, called nirsevimab, in partnership with Sanofi. It is administered as a single injection and functions similarly to a vaccine.
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