Moderna's RSV vaccine for older adults approved
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Image: Courtesy of Moderna
Moderna's RSV shot for adults 60 and older was approved by the Food and Drug Administration on Friday, joining a growing group of vaccines protecting against the major respiratory threat.
Why it matters: It's Moderna's second approved product, and company officials said it's the first mRNA vaccine approved for a disease other than COVID-19.
Driving the news: Moderna expects to launch its vaccine, mResvia, in time for respiratory virus season this fall.
- In a phase 3 clinical trial of 37,000 adults 60 and older across 22 countries, the vaccine had 83.7% efficacy against RSV lower respiratory tract disease after nearly four months.
- No serious safety concerns were identified in the trial, with the most commonly reported adverse reactions including injection site pain, fatigue, headache, muscle pain and joint stiffness.
State of play: Moderna's vaccine will compete against the first two RSV shots for this age group, which launched last year: GlaxoSmithKline's Arexvy and Pfizer's Abrysvo.
- About 1 in 4 adults 60 and older have received an RSV vaccine, according to federal data.
- Pfizer earlier this year released trial results showing its shot offered durable protection to older adults after two respiratory virus seasons. GSK trial data showed its vaccine was 83% effective at reducing symptomatic infection in this age group.
- Moderna CEO Stéphane Bancel said his company's shot would be easy to administer.
- "It is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators' time and reducing the risk of administrative errors," Bancel said in a statement.
What we're watching: Moderna shares jumped this week after Reuters reported the U.S. government may be nearing a deal to fund the company's late-stage trial of an mRNA vaccine against bird flu.
