The first respiratory syncytial virus vaccine, better known as RSV, has been approved by the United States Food and Drug Administration (FDA) for adults 60 and older. The vaccine developer, British pharmaceutical company GSKsaid it should be available in the United States in a few months.
RSV is a common virus that circulates in fall and winter. It usually causes mild, cold-like symptoms, but can be life-threatening to very young children and older adults. In the United States, between 6,000 and 10,000 adults age 65 and older die each year from RSV and up to 160,000 are hospitalized.
“Older adults, especially those with underlying health conditions, such as heart or lung disease or a weakened immune system, are at high risk of severe illness from RSV,” said Stone Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Today’s approval of the first RSV vaccine is a significant public health achievement in preventing a potentially life-threatening disease.”
The FDA’s decision was based on data from a trial in progress involving approximately 25,000 adults aged 60 and over. The trial found that a single dose of the vaccine was nearly 83% effective in preventing lower respiratory tract disease caused by RSV and about 94% effective in preventing severe disease.
Common side effects of the vaccine include pain at the injection site, fatigue, headache, and joint stiffness. Ten participants in the vaccine group and four in the placebo group also developed an irregular and rapid heartbeat within 30 days of their injection, a potential risk that GSK is continuing to investigate.
A US Centers for Disease Control and Prevention advisory committee will announce recommendations on the appropriate use of the vaccine in June. Several other countries are expected to make decisions on approving the vaccine later this year.
“Our goal now is to ensure that eligible seniors in the United States can access the vaccine as quickly as possible and to advance regulatory review in other countries,” said Tony Woodchief scientific officer of GSK, in a press release.