With one abstention, the FDA’s independent Vaccines and Related Biological Products Advisory Committee voted 7-4 in favor of recommending the vaccine based on its efficacy. According to Pfizer, the single-dose shot can reduce the risk of respiratory syncytial virus illness by up to 86%.
The FDA must then approve the vaccine, which could take several months, though the agency usually follows the recommendations of the advisory committee. Before the shot is made available to the public, the Centers for Disease Control and Prevention must recommend it after FDA approval. If all of that happens, this will be the first RSV vaccine approved in the United States.
The advisory committee will reconvene on Wednesday to assess the safety and efficacy of a similar RSV vaccine for older adults, this time developed by GlaxoSmithKline. The shot reduced the risk of symptomatic illness by 83% and severe illness by 94% in adults aged 60 and up, according to trial data published earlier this month in the New England Journal of Medicine.
RSV causes lower respiratory illness, though most healthy adults experience only mild symptoms. In severe cases, RSV can cause bronchiolitis, in which the airways become inflamed and clogged with mucus or pneumonia.
Such outcomes are especially dangerous for the elderly and infants. Every year, RSV kills over 10,000 adults 65 and older, as well as approximately 300 children under the age of five in the United States. Cases among infants spiked dramatically earlier this winter, overwhelming children’s hospitals — a reminder of the virus’s threat.