RSV vaccine is approved for older adults
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The first vaccine against respiratory syncytial virus, better known as RSV, was approved by the US Food and Drug Administration (FDA) for adults 60 years and older. British pharmaceutical company GSK, the developer of the vaccine, says it will be available in the United States within months.
RSV is a virus that is prevalent from autumn to winter. It usually causes mild cold-like symptoms, but can be life-threatening in very young children and the elderly. In the United States, 6,000 to 10,000 adults aged 65 and older die from RSV each year, and up to 160,000 are hospitalized.
“Older people, especially those with underlying medical conditions such as heart or lung disease or a weakened immune system, are at increased risk of serious illness from RSV,” said Peter W. Marks said. in a statement. “Today’s first approval of his RSV vaccine is an important public health achievement for preventing a potentially life-threatening disease.”
The FDA’s decision is based on data from ongoing trials involving approximately 25,000 adults age 60 and older. The trial found that a single dose of the vaccine was about 83% effective in preventing RSV-induced lower respiratory tract disease and about 94% effective in preventing severe disease.
Common side effects of vaccines include injection site pain, fatigue, headaches, and joint stiffness. Her 10 participants in the vaccine group and her 4 participants in the placebo group also developed irregular and rapid heartbeats within 30 days after vaccination. It is a potential risk that GSK continues to investigate.
An advisory panel for the US Centers for Disease Control and Prevention will release recommendations on the appropriate use of vaccines in June. Several other countries are expected to make decisions on vaccine approvals later this year.
GSK’s Chief Scientific Officer Tony Wood said in a statement: “Currently, our goal is to ensure that eligible seniors in the United States have access to vaccines as soon as possible and to proceed with regulatory reviews in other countries. is focused on,” he said.
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