FDA approves first-ever RSV vaccine, shots will be available for seniors

The Food and Drug Administration on Wednesday approved the first-ever vaccine to fight severe respiratory syncytial virus, or RSV.

Arexvy, the new vaccine, developed by GlaxoSmithKline, was approved for adults 60 years and older and was 82% effective in preventing lower respiratory tract disease caused by RSV, according to trial data. It was also 94% effective in those who had at least one underlying medical condition.

“Today’s approval of the first RSV vaccine is a significant public health achievement in preventing a potentially life-threatening disease and reflects the FDA’s continued commitment to facilitating vaccine development. safe and effective to use in the United States,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Respiratory syncytial virus infects almost everyone by the age of 2 and usually causes cold symptoms. But it is also the main cause of hospitalization in newborns and young children. Among those under age 5, the Centers for Disease Control and Prevention reports between 58,000 and 80,000 hospitalizations annually.

RSV also strikes late in life, causing more than 177,000 hospitalizations and 14,000 deaths in the elderly each year.

At an FDA advisory committee meeting in February, GSK researchers reported a few cases of post-vaccination neurological disorders, including a case of Guillain-Barré in a 78-year-old woman in Japan about nine days after receiving the vaccine.

However, panel members voted to recommend the vaccine, saying it was still safe and effective for older people.

Guillain-BarrĂ© syndrome, or GBS, is a rare neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis, according to the CDC. According to the National Institute of Neurological Disorders and Stroke, about 70% of people diagnosed with GBS make a full recovery. Symptoms can persist for years, but experts say most people recover within months.

RSV vaccines Baby and adult shots are on the way. Here’s what the CDC says about them.

Other RSV vaccines in the works

GSK’s vaccine is one of several RSV vaccines and treatments under review by regulatory agencies. Others include:

  • Sanofi’s monoclonal antibody for infants and toddlers: A monoclonal antibody from Sanofi and AstraZeneca, called nirsevimab, helps prevent RSV lower respiratory tract disease in newborns and infants entering or during their first RSV season. If approved, it would be the second monoclonal antibody on the market for infants.

  • Pfizer’s RSV vaccine for pregnant women: The FDA said it has agreed to review Pfizer’s vaccine candidate, RSVpreF, for approval and has set an action date for August 2023. If approved, the vaccine would be for pregnant women to help to protect against severe RSV disease in infants from birth to 6 months of age.

  • Pfizer’s vaccine for the elderly: This vaccine candidate has the same name as the maternal vaccine, RSVpreF. Data from Pfizer revealed that its vaccine was more than 85% effective in preventing RSV-associated lower respiratory tract disease in the elderly.

Contributor: Karen Weintraub, USA TODAY. Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Coverage of patient health and safety at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: FDA approves world’s first RSV vaccine for seniors

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