HQ Team
October 23, 2024: The US Food and Drug Administration has greenlighted Pfizer Inc.’s respiratory syncytial virus vaccine (RSV) Abrysvo for treating lower respiratory tract disease in people 18-59 years.
Abrysvo was previously approved for people over 60 and remains the sole immunisation cleared for pregnant women to protect infants from birth up to six months.
“RSV represents a significant threat to younger adults with certain chronic conditions. We now have the opportunity to help alleviate the burden of RSV in this high-risk adult population,” said Aamir Malik, Chief U.S. Commercial Officer and Executive Vice President of Pfizer.
The FDA’s decision was based on “inferred efficacy” from the end-stage trial which investigated the safety, tolerability, and immunogenicity of the vaccine in adults at risk of RSV-associated disease due to certain chronic medical conditions.
Severe illness or death
Respiratory syncytial virus is a contagious virus and a common cause of respiratory illness. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.
Chronic cardiovascular disease, chronic lung disease, moderate or severe immune compromise, diabetes complications, and severe obesity are among the conditions that increase an individual’s risk for severe RSV.
There are two major subgroups of RSV: RSV-A and RSV-B. Both subgroups cause disease and can co-circulate or alternate predominance from season to season.
Among the US adults aged between 18 and 49 years, 9.5% have an underlying chronic condition, such as obesity, diabetes, chronic obstructive pulmonary disease, heart failure, chronic kidney disease, and asthma.
50-64 years st increased risk
This puts them at increased risk of developing and being hospitalised for RSV-associated lower respiratory tract disease, and this rises to 24.3% among those between 50 and 64 years of age.
In May 2023, the FDA approved Abrysvo for the prevention of LRTD caused by RSV in individuals 60 years of age or older.
In June 2024, the Advisory Committee on Immunization Practices (ACIP) voted to update its recommendation of RSV vaccines for use in adults aged 75 years and above and adults aged 60-74 years who are at increased risk for severe RSV disease.
The FDA approved Abrysvo for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunisation of pregnant individuals at 32 through 36 weeks gestational age.
This was followed in September 2023 with ACIP’s recommendation for maternal immunisation to help protect newborns from RSV seasonally, where the vaccine should be administered from September through January in most of the continental United States.
Also in August 2023, Pfizer announced that the European Commission granted marketing authorization for Abrysvo for both older adults and maternal immunization to help protect infants.
