The Food and Drug Administration (FDA) on Wednesday approved Pfizer's vaccine to prevent the respiratory disease RSV in older adults, the company announced.
The approval of Pfizer's Abrysvo marks the second authorized RSV shot for older adults in the U.S. this month, after GlaxoSmithKline won approval for its rival shot, Arexvy.
"A vaccine to help prevent RSV had been an elusive public health goal for more than half a century," said Annaliesa Anderson, Pfizer's chief scientific officer for vaccine research and development. "Today’s approval is a monumental step forward in delivering on Pfizer’s commitment to help alleviate the significant burden of RSV in higher-risk populations."
FDA is also considering Pfizer’s maternal RSV vaccine, intended to be given to pregnant individuals to help protect against RSV in infants. A monoclonal antibody treatment from Sanofi and AstraZeneca is also under review.
The Centers for Disease Control and Prevention will still need to sign off on any shot or treatment before it can reach the public. The agency's independent advisory panel will meet twice next month to make recommendations.
Pfizer's vaccine is expected to be available before the start of next RSV season.
In healthy adults and older children, RSV typically causes mild, cold-like symptoms that go away with moderate rest and self care.
But older adults are at increased risk of severe RSV illness and drive the majority of RSV hospitalizations.
The virus causes between 60,000 and 160,000 hospitalizations annually for adults older than 65 in the U.S. and 6,000 to 13,000 deaths, according to federal statistics.
