March 2, 2023 -- An FDA advisory panel has recommended two vaccines to become the first to fight respiratory syncytial virus (RSV) in older adults.
The FDA usually approves the panel’s recommendations. The agency could formally give its OK within a few months, reported The New York Times. Shots could be made available before the expected winter surge of cases.
RSV complicated the 2022-2023 flu season, already made worse by COVID-19.
The panel discussed vaccines from Pfizer and GSK that would seek to protect people over age 60. According to the FDA, RSV contributes to up to 10,000 deaths a year among people over age 65, plus at least 60,000 hospitalizations.
In addition to older adults, RSV infects young children, with more than 100,000 deaths worldwide in kids age 5 and younger in 2019, The New York Times reported. RSV vaccines are being developed for children and for use during the later months of pregnancy.
Pfizer’s trial involved 34,000 people, the FDA said. It was effective in preventing RSV-related lower respiratory tract illness 67% of the time. It also was almost 86% effective in treating the disease among patients who had three or more symptoms.
GSK’s tests studied 25,000 patients. It was 83% effective against lower respiratory tract illnesses.
In both trials, half the participants received placebos, and there were no RSV-related deaths.
A handful of patients developed serious health conditions, including Guillain-Barré and acute disseminated encephalomyelitis. The manufacturers said they will monitor the shots’ safety after FDA approval.
