FDA Panel Recommends 2 RSV Vaccines for Older Adults

Advisers did not view approval as a simple choice, though. They debated the benefits of a vaccine for R.S.V. patients who overwhelmingly avoided hospitalization against the very few, but concerning, reports of autoimmune conditions like Guillain-Barré syndrome that emerged shortly after the shots were administered.

On Tuesday, the panel voted in favor of the Pfizer vaccine by 7 to 4, with one abstention, on its safety and efficacy. On Wednesday, it voted 10 to 2 in favor of the GSK vaccine’s safety and unanimously on the shot’s efficacy.

About 34,000 patients were studied in Pfizer’s trial, with half getting a placebo, according to an F.D.A. summary of the data. The vaccine was deemed nearly 67 percent effective in preventing R.S.V.-related lower respiratory tract illness, which can lead to pneumonia. That vaccine was nearly 86 percent effective in treating the disease with three or more symptoms, according to the data.

The GSK vaccine was nearly 83 percent effective in lower respiratory tract illness in a study of about 25,000 patients — half on the vaccine and half on a placebo, according to data the company provided to the F.D.A. No R.S.V. deaths were reported among the patients in the GSK study.

Several panel members expressed concerns about side effects reported with each vaccine. After seven days, one patient who received the Pfizer vaccine developed Guillain-Barré syndrome, a condition where the immune system attacks the nervous system (but not the spine or brain). The case was considered life-threatening, F.D.A. records show, though a “potentially confounding factor” was that the patient had suffered a heart attack the day before the condition developed.

Article source: https://www.nytimes.com/2023/03/01/health/rsv-vaccine-fda.html