Health Sciences Authority approves Pfizer’s respiratory syncytial vaccine

Abrysvo is the first RSV vaccine approved for use in both older adults and pregnant individuals. 

Pfizer Singapore announced that the Health Sciences Authority has approved the company’s Abryvso vaccine for respiratory syncytial virus (RSV). 

This vaccine aims to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age and for individuals 60 years of age and older. 

It also boosts the immunisation of pregnant individuals at 32 to 36 weeks gestational age. 

The approval of Abrysvo is based on the results of two pivotal Phase 3 clinical trials that assessed the efficacy and safety of Abrysvo in infants and older adults. 

In the MATISSE (Maternal Immunisation Study for Safety and Efficacy) study, Abrysvo demonstrated an 81.8% efficacy in preventing severe RSV-related LRTD in infants within 90 days after birth when administered to pregnant women (24 to 36 weeks). 

Abrysvo also demonstrated an efficacy of 69.4% within 180 days and 41.0% within 360 days. 

The vaccine efficacy against severe LRTD caused by RSV for infants from birth through 6 months of age by active immunisation of pregnant individuals at 32 through 36 weeks gestational age was 91.1% at 90 days and 76.5% at 180 days after birth.

In older adults, the RENOIR (RSV vaccine efficacy study in older adults immunised against RSV disease) study found a vaccine efficacy of 85.7% in preventing RSV-related LRTD with three or more symptoms, without evident safety concerns reported in the Phase 3 clinical trial.

“The availability of this RSV vaccine marks a significant step in paediatric healthcare, providing infants with early protection through their mothers,” said Dr. Mohana Rajakulendran, Paediatrician, Petite Practice. “This would reduce their risk of developing severe forms of lower respiratory tract infection, which presently cause significant morbidity in infants.”

In Singapore, around 75% of RSV hospitalisations occur in children under six months, who are 2.5 times more likely to be hospitalised than older infants.  

Starting in November, patients at risk of RSV can access the vaccine at clinics and hospitals islandwide.