FDA approves first RSV vaccine for at-risk adults younger than 50
Approved vaccine Abrysvo now cleared for use in adults as young as 18
The U.S. Food and Drug Administration (FDA) has approved Abrysvo, a vaccine that protects against lung infections caused by the respiratory syncytial virus — commonly known as RSV — for adults as young as 18 with chronic obstructive pulmonary disease (COPD) or other conditions that increase the risk of such infections.
Abrysvo was already cleared in the U.S. for adults older than 60 and pregnant people at 32-36 weeks of gestation to protect infants from birth to age 6 months. With the new authorization, Abrysvo became the only RSV vaccine approved for use in adults younger than 50 in the U.S., according to its developer Pfizer.
“RSV represents a significant threat to younger adults with certain chronic conditions,” Aamir Malik, chief U.S. commercial officer and executive vice president at Pfizer, said in a company press release. “After decades of vaccine research by the scientific community and Pfizer, we now have the opportunity to help alleviate the burden of RSV in this high-risk adult population.”
COPD is marked by chronic inflammation in the lungs, leading to symptoms like shortness of breath and coughing. While adults of any age can develop COPD, the disease most commonly affects those ages 40 or older.
As such, the new approval is expected to offer protection from RSV to the youngest COPD patients for whom no vaccine was approved before now.
“With this approval, we are proud that Abrysvo is now the only RSV vaccine indicated for adults aged 18 to 49 at increased risk for the disease, expanding on its existing indications for older adults and pregnant women,” Malik said.
About 10% of COPD patients may develop RSV infection symptoms
RSV is one of the most common viruses that infect the lungs, and RSV infections can be disabling or even life-threatening. About 10% of COPD patients may develop symptoms of an RSV infection, and more than half of those infected may need hospitalization.
Vaccines like Abrysvo work by training the body’s immune system to recognize a threat so that it can more rapidly and effectively mount a defense when it is encountered.
The FDA’s new approval for Abrysvo was based on data from a U.S.-based Phase 3 clinical trial called MONeT (NCT05842967), completed earlier this year. That trial tested the vaccine in 886 adults, including those with COPD, at risk of severe RSV disease.
The results showed the vaccine was generally safe in this high-risk patient population. Further, it was found to effectively induce an immune reaction against the virus that was not inferior to those observed in adults ages 60 and older in a previous Phase 3 trial.
Abrysvo’s safety profile in MONeT was similar to what’s been seen for this vaccine in other populations. Common side effects included injection site pain, muscle or joint pain, and nausea.
According to Pfizer, Abrysvo last year received marketing authorization in the European Union for both older adults and maternal immunization, and has been widely approved worldwide for both indications.
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