News from the FDA/CDC

CDC signs off on RSV vaccine for older adults


 

The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.

CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.

The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.

On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.

RSV vaccines

RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.

The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.

The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.

He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.

Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.

The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.

Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.

A version of this article first appeared on WebMD.com.

This article was updated 7/5/23.

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