FDA Panel Backs Second RSV Vaccine for Older Americans

THURSDAY, March 2, 2023 (HealthDay News) -- Following hours of discussion over safety concerns, a U.S. Food and Drug Administration advisory panel on Wednesday recommended approval of a second respiratory syncytial virus (RSV) vaccine, this one made by GlaxoSmithKline (GSK), for use in Americans ages 60 years and older.

The panel's recommendation was based largely on the results of a trial that tested the GSK vaccine in the same age group. Those findings, published recently in the New England Journal of Medicine, showed that the shot lowered the risk for symptomatic illness by 83 percent and for severe illness by 94 percent in people ages 60 years and older.

In a two-part vote, the panel voted 10 to 2 in favor of the vaccine's safety and unanimously on the shot's effectiveness, The New York Times reported.

Meanwhile, the same panel on Tuesday recommended the approval of an RSV vaccine known as RENOIR from Pfizer.

On both days, panel members debated the benefits of the vaccines for patients who overwhelmingly avoided hospitalization against rare reports of autoimmune conditions like Guillain-Barré syndrome that emerged shortly after the shots were administered. In addition, two people who were given the GSK vaccine developed acute disseminated encephalomyelitis. One person died. The company and the FDA consider the cases "possibly related" to the vaccine, noting that both patients also received a flu vaccine at the same time as the RSV shot, The Times reported.

Watching the safety of both vaccines after they are approved will be critical, Henry Bernstein, M.D., from the Zucker School of Medicine at Hofstra University in Hempstead, New York, told The Times. "I don't know that there's a rush to get this to market if we're going to take two steps forward, and three steps back as far as public health and optimizing vaccination rates," Bernstein noted.

The New York Times Article