First RSV Vaccine for Older Adults Approved in U.S.

Last week, the U.S. Food and Drug Administration (FDA) gave the world’s first approval of a vaccine to target respiratory syncytial virus (RSV) in older adults. The agency greenlit the shot for people 60 and older, who are at a higher risk from the potentially deadly virus.

“It’s a very big deal to have options available to prevent RSV disease,” Barney Graham, senior adviser for global-health-equity trials at Morehouse School of Medicine, tells Nature News’ Myriam Vidal Valero.

But before the vaccine can go into arms, it must be recommended by the Centers for Disease Control and Prevention (CDC), which could happen after an agency vaccine expert panel meets on June 21 and 22, according to Stat News’ Helen Branswell. GSK, the pharmaceutical company behind the vaccine, said it would be available in the U.S. in the fall, per the New York Times’ Christina Jewett.

Most of the time, RSV infections cause only mild, cold-like symptoms, according to the CDC. But in some cases, the virus is linked to more serious illness, particularly in infants and older adults. RSV can lead to lower respiratory tract disease, which can cause lung infections like pneumonia and bronchiolitis, per a statement from the FDA.

Anually, an estimated 60,000 to 160,000 older adults in the U.S. are hospitalized and 6,000 to 10,000 die because of RSV infections, according to the CDC. An estimated 58,000 to 80,000 children under five are hospitalized with RSV each year.

While it is not common for children in the U.S. to die from the virus, it’s the second-highest cause of death in children under one worldwide, according to Stat News. The National Institute of Allergy and Infectious Diseases estimates that RSV leads to an estimated 160,000 total deaths each year.

The FDA’s approval was informed by a trial of 25,000 adults aged 60 and older. Half the participants were given the vaccine, while the other half received a placebo. Compared to the placebo group, those who got the vaccine were 82.6 percent less likely to develop RSV-related lower respiratory tract disease and 94.1 percent less likely to develop RSV-related severe lower respiratory tract disease, according to the FDA’s statement. The results of the trial were published in February in the New England Journal of Medicine.

GSK’s RSV vaccine is not the only one that could soon be available to the public. Later this month, the FDA is expected to approve an RSV vaccine for older adults from Pfizer, writes the New York Times. A large study found that shot to be almost 67 percent effective at preventing RSV-related illness.

The FDA will decide by August whether to approve Pfizer’s RSV vaccine for pregnant people to prevent illness in infants. And the agency is considering a monoclonal antibody treatment for babies, writes the Washington Post’s Carolyn Y. Johnson and David Ovalle.

In a separate study of GSK’s vaccine, one participant developed a rare disorder called Guillain-Barré syndrome—when the body’s immune system attacks its nerve cells—nine days after they received the vaccine. And in another study, two participants who received the RSV vaccine and an FDA-approved influenza vaccine developed a rare type of inflammation of the brain and spinal cord, and one of them died.

Approximately 2,500 participants received the RSV vaccine in these two other trials. The FDA is requiring GSK to conduct a study tracking the two rare possible side effects after the vaccines are available to the public.

GSK hopes its vaccines will be available before the winter RSV season begins, according to the Washington Post. Last winter’s season was particularly strong, with children’s hospitals overwhelmed while the country also grappled with Covid-19 and the flu.

While GSK has not said how much the vaccine will cost, insurance companies typically cover a lot of a vaccine’s price, per the New York Times.

Will Sullivan | | READ MORE

Will Sullivan is a science writer based in Washington, D.C. His work has appeared in Inside Science and NOVA Next.