SINGAPORE: The Health Sciences Authority (HSA) has approved Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, marking a milestone in preventing lower respiratory tract disease (LRTD) in vulnerable groups.
This is the first RSV vaccine approved in Singapore for use in older adults and pregnant individuals, providing critical protection to infants and seniors.
Pfizer Singapore made the announcement, highlighting Abrysvo’s role in preventing LRTD and severe LRTD caused by RSV in infants from birth to six months of age, as well as in individuals aged 60 and older.
The vaccine is also designed to boost immunity in pregnant individuals between 32 and 36 weeks of gestation, offering early protection to newborns.
The approval follows two key Phase 3 clinical trials demonstrating the vaccine’s efficacy and safety.
In the MATISSE (Maternal Immunisation Study for Safety and Efficacy) trial, Abrysvo showed an 81.8% efficacy in preventing severe RSV-related LRTD in infants within 90 days of birth when administered to mothers during pregnancy.
This protection persisted, with an efficacy rate of 69.4% at 180 days and 41.0% at one year.
Further, the vaccine showed a significant 91.1% efficacy at 90 days and 76.5% at 180 days in preventing severe LRTD in infants when administered to pregnant individuals between 32 and 36 weeks of gestation.
In older adults, the RENOIR study (RSV vaccine efficacy study in older adults) demonstrated an 85.7% efficacy in preventing RSV-related LRTD, with no significant safety concerns reported during the trial.
RSV is a leading cause of respiratory illness in young children. In Singapore, approximately 75% of hospitalisations related to RSV involve children under six months old, who are 2.5 times more likely to be hospitalised compared to older infants.
Starting in November, the Abrysvo vaccine will be available in clinics and hospitals across Singapore for individuals at risk of RSV infection.