FDA approves first RSV vaccine, shots to be available for older adults

Adrianna Rodriguez, USA TODAY
·3 min read
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The Food and Drug Administration approved Wednesday the first vaccine to combat severe respiratory syncytial virus, or RSV.

Arexvy, the new vaccine developed by GSK, formerly known as GlaxoSmithKline, was approved for adults 60 and older and was 82% effective at preventing lower respiratory tract illness 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 an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

Respiratory syncytial virus infects nearly everyone by age 2 and typically causes cold symptoms. But it’s also the leading cause of hospitalizations among newborns and younger children. Among those under 5, the Centers for Disease Control and Prevention reports between 58,000 and 80,000 hospitalizations a year.

RSV also strikes late in life, causing more than 177,000 hospitalizations and 14,000 deaths among older adults each year.

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

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

Guillain-Barré 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. About 70% of people diagnosed with GBS make a full recovery, according to the National Institute of Neurological Disorders and Stroke. Symptoms may persist for years, but experts say most people recover within a few months.

RSV vaccines Shots for babies and adults are on the way. Here's what the CDC is saying 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 people: The FDA said it has agreed to review Pfizer’s vaccine candidate, RSVpreF, for approval and set an action date for August. If approved, the vaccine would be for pregnant people to help protect against RSV severe disease in infants from birth through 6 months.

  • Pfizer's vaccine for older adults: This vaccine candidate is under the same name as the maternal vaccine, RSVpreF. Pfizer data found its vaccine was more than 85% effective at preventing RSV-associated lower respiratory tract illness in older adults.

Contributing: Karen Weintraub, USA TODAY.

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.

Health and patient safety coverage 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 older adults