FDA approves first-ever RSV vaccine for people 60 and older

Published 10:40 am Tuesday, May 9, 2023

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People 60 and older now have access to the first approved vaccine against respiratory syncytial virus. The vaccine, developed by GlaxoSmithKline, is called Arexvy and was approved May 3 by the Food and Drug Administration.

“Today’s approval of the first RSV vaccine is an important public-health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” Dr. Peter Marks, director of the FDA’s Center for Biologies Evaluation and Research, said in a news release.

The release said the FDA concluded that the vaccine is safe and effective from scientific analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and other nations among individuals 60 years of age and older. The trial had nearly 25,000 participants.

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The study showed that the vaccine reduced the risk of people 60 and older from developing a lower-respiratory-tract infection from RSV by 83 percent, and severe disease by 94%.

When a person gets RSV, they typically have mild, cold-like symptoms, but for some older adults, it can be deadly, according to the Centers for Disease Control and Prevention.

Each year, between 60,000 and 160,000 older adults in the U.S. are hospitalized due to an RSV infection and between 6,000 and 10,000 of them die from it, the CDC says.

Older adults are at more risk of serious complications from RSV because our immune systems weaken as we get older. The CDC Says those with chronic lung or heart disease or weakened immune systems are at the highest risk for severe RSV.

“With this vaccine, Americans over the age of 60, and particularly those with underlying health conditions like COPD, asthma, or congestive heart failure, will have a vaccine to help protect against potentially serious outcomes from RSV,” Dr. John Kennedy, president of the American Medical Group Association, said in a GSK news release.

Arexvy will be rolled out ahead of the fall and winter RSV season, Carolyn Y. Johnson of The Washington Post reports in an article that explores the new vaccine’s side effects and what’s in it.

Johnson notes that the new vaccine does not come from new technology: “This is a protein-based vaccine, similar to ones that are used against other diseases, including a hepatitis B vaccine, a shingles shot and an influenza vaccine. The protein in the vaccine is produced by cells in a laboratory.”