Pfizer Secures FDA Approval to Expand RSV Vaccine Abrysvo for High-Risk Adults Aged 18-59

Expanded Approval:
The FDA has approved Pfizer's RSV vaccine Abrysvo for use in adults aged 18 to 59 who are at higher risk of RSV-related lower respiratory tract disease (LRTD).

Target Population:
This expansion targets younger adults with chronic conditions such as diabetes or obesity, who are more susceptible to RSV LRTD and associated hospitalizations.

Clinical Evidence:
The approval is based on the Phase III MONeT trial, which showed that Abrysvo elicited a non-inferior immune response in younger adults compared to participants aged 60 years and above.

Market Position:
This approval could help Pfizer narrow the gap with GSK, whose vaccine Arexvy was approved earlier for adults aged 60 and above, and for those 50 to 59 years old who are at risk of RSV LRTD.

Unique Indication:
Abrysvo is the first and only RSV vaccine approved for use in adults younger than 50 years of age, offering the broadest RSV vaccine indication for adults.

Previous Approvals:
Abrysvo was previously approved for adults aged 60 and older and for maternal immunization to protect infants from birth through six months.