RSV: US approves vaccine for older adults

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RSV vaccine approved for older adults

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The first vaccine against respiratory syncytial virus, better known as RSV, has been approved by the US Food and Drug Administration (FDA) for adults 60 years and older. UK pharmaceutical company, developer of the vaccine GSKSaid it should be available in the US in several months.

RSV is a common virus that spreads in autumn and winter. It usually causes mild, cold-like symptoms but can be life-threatening for very young children and older adults. In the US, between 6,000 and 10,000 adults 65 and older die from RSV each year, 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 higher risk of severe illness caused by RSV,” said Peter Marxdirector of the FDA’s Center for Biologics Evaluation and Research said in a statement. “Today’s approval for the first RSV vaccine is a significant public health achievement in preventing a disease that can be life-threatening.”

The FDA’s decision was based on data from a running test About 25,000 adults age 60 and older are included. The trial found that a single dose of the vaccine was about 83 percent effective in preventing lower respiratory tract disease caused by RSV, and about 94 percent 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 participants in the placebo group also developed an irregular and rapid heartbeat within 30 days of their shot, a potential risk GSK continues to investigate.

An advisory committee from the US Centers for Disease Control and Prevention will announce recommendations on the appropriate use of the vaccine in June. A decision on the approval of the vaccine by several other countries is expected later this year.

“Our focus now is to ensure that eligible older adults in the US have access to the vaccine as quickly as possible and to advance regulatory review in other countries,” said Tony WoodGSK Chief Scientific Officer said in a statement.


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