US-based drugmaker Pfizer has received the US Food and Drug Administration (FDA) expanded approval for its respiratory syncytial virus (RSV) vaccine Abrysvo.
Abrysvo is a bivalent RSV prefusion F (RSVpreF) vaccine, previously approved in the US, to prevent lower respiratory tract disease (LRTD) caused by RSV in infants and older adults.
The current approval expands the vaccine’s indication to include individuals aged between 18 and 59 years, who are at increased risk for LRTD caused by RSV.
According to Pfizer, Abrysvo currently covers the broadest RSV vaccine indication for adults.
Also, it is the only RSV vaccine approved for administration in pregnant individuals at 32 to 36 weeks of gestation to protect infants from birth up to six months of age.
Pfizer chief US commercial officer and executive vice president Aamir Malik said: “RSV represents a significant threat to younger adults with certain chronic conditions.
“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.
“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.”
The FDA approval is based on inferred efficacy from the Phase 3 MONeT clinical trial.
The Phase 3 study evaluated the safety, tolerability, and immunogenicity of Abrysvo in adults at risk of RSV-associated disease due to certain chronic medical conditions.
According to Pfizer, Abrysvo is designed to protect RSV-LRTD, regardless of virus subgroup.
In May last year, the vaccine was approved by the US FDA to prevent LRTD caused by RSV in individuals aged 60 years and above.
In August, the FDA expanded the approval to include infants from birth up to six months, through active immunisation of pregnant individuals at 32 through 36 weeks gestational age.
In the same month, Pfizer received the European Commission (EC) marketing authorisation for ABRYSVO for both older adults and maternal immunisation to help protect infants.
In June this year, the Advisory Committee on Immunization Practices (ACIP) recommended RSV vaccines for older adults aged ≥75 years and adults at increased risk, aged 60-74 years.
