In a close vote, Food and Drug Administration advisers recommended Tuesday that the agency approve the nation’s first RSV vaccine for seniors, a shot from Pfizer for adults 60 and older.
The FDA’s Advisory Committee on Vaccines and Related Biologicals voted 7-4 in favor of recommending the vaccine based on its efficacy, with one abstention. Single-dose injection has been shown to reduce the risk of respiratory syncytial virus disease by up to 86%, according to pfizer.
The next step is for the FDA to approve the vaccine, which could take several months, though the agency typically follows the advisory committee’s recommendations. After FDA approval, the Centers for Disease Control and Prevention must recommend the vaccine before it is available to the public. If all of that happens, this would be the first RSV vaccine approved in the US.
The second may be hot on your heels. The advisory committee will meet again on Wednesday to evaluate the safety and efficacy of a similar RSV vaccine for older adults, this one from GlaxoSmithKline. Test data published earlier this month in the New England Journal of Medicine showed that the shot reduced the risk of symptomatic disease by 83% and severe disease by 94% in adults 60 and older.
RSV causes lower respiratory tract disease, although for most healthy adults the symptoms are mild. However, in severe cases, RSV can lead to bronchiolitis, which causes the airways to become inflamed and blocked with mucus or pneumonia.
Older people and babies are particularly vulnerable to such results. RSV Bush more than 10,000 adults 65 and older and about 300 children under age 5 each year in the U.S. Cases spiked among infants earlier this winter, overwhelming children’s hospitals, a reminder of the virus threat.
At Tuesday’s advisory committee meeting, a separate vote evaluating the safety of Pfizer’s vaccine resulted in the same distribution: seven votes in favor, four against and one abstention.
Several of the experts who did not vote in favor of the vaccine based on its efficacy expressed concern that there were not enough RSV-infected trial participants to properly evaluate the shot. Those who voted «no» based on the vaccine’s safety profile were largely concerned about its possible association with Guillain-Barré syndrome (GBS), a rare neurological disorder that damages nerve cells and causes muscle weakness or paralysis. .
«It was a 1 in 9,000 risk of GBS, which is concerning,» said Dr. Hana El Sahly, chair of the FDA’s advisory committee, who voted against the injection based on its safety profile but in favor. depending on the effectiveness.
Pfizer tested its same RSV vaccine in pregnant women to see if the protection could be passed on to babies in the womb. the company said their data suggest the vaccine reduced the risk of severe disease in infants by 82% during the first 90 days of life and by 69% during six months.
But the FDA committee’s vote Tuesday was limited to the use of the vaccine for older people. The agency is still reviewing Pfizer’s data for pregnant people, with a decision expected in August.
According to a FDA information document published before Tuesday’s meeting, the most common side effects of Pfizer’s vaccine among older people were fatigue, headache, pain at the injection site, and muscle pain. The document also highlighted the potential risk of Guillain-Barré syndrome.
One man in the Pfizer trial developed Guillain-Barré after receiving the vaccine, and one woman developed Miller Fisher syndrome, a rare Guillain-Barré-related nerve disease.
The most common side effects of the GSK vaccine were similar (injection site pain, fatigue, and muscle pain), but participants in that trial reported side effects more frequently than those from Pfizer.
The race to an RSV vaccine
Several companies have been competing to get FDA approval for RSV vaccines.
In total, 11 RSV vaccines are being actively studied in trials in the US, according to data from PATH, a nonprofit global health organization.
Moderna has said that an RSV vaccine it developed for older adults could be submitted to the FDA in July. Bavarian Nordic expects to have late-stage trial data for its RSV vaccine, which targets the same demographic, by mid-year.
The FDA is also reviewing data from trials of a monoclonal antibody injection designed to protect infants from RSV, which works similar to a vaccine. The shot, from Sanofi and AstraZeneca, has already been approved in Europe.