RSV vaccine trialled at Barwon Health approved for pregnant women in US
A vaccine trialled at Barwon Health has been approved for use on pregnant women in America to protect babies from respiratory syncytial virus (RSV).
Pfizer’s Abrysvo vaccine has been approved by the US FDA as the first maternal vaccine to help protect infants at birth through six months from lower respiratory tract disease due to RSV.
RSV causes cold-like symptoms, but infants and older adults are more likely to develop severe cases. The disease burden of RSV in young children is extremely high, with virtually all children getting an RSV infection by the time they are two years old.
Bree Sarah, research operations manager at Barwon Health’s Adrian Costa Clinical Trials Centre (pictured), said the health service’s clinical trials unit had four participants enrolled in the study during pregnancy.
“The trial involved a single vaccine (blinded to either placebo or the RSV vaccine), a seven-day diary to monitor for any reactions to this vaccine, and two blood tests for serologic assessment,” Ms Sarah said.
“Information from their birth was also recorded.
“Infant participants born to enrolled maternal participants were followed from birth to either 12 months or 24 months of age for RSV surveillance and safety.
“Cord blood was collected at delivery for serologic assessment and regular physical examinations were conducted by the study paediatrician.”
Abrysvo, administered as a single dose injection into the muscle, is approved for use in the US at 32 through 36 weeks’ gestational age of pregnancy.
There are currently no RSV vaccines registered for use in Australia. The Australian Government Therapeutic Goods Administration (TGA) has commenced evaluating an application from Pfizer Australia to register Abrysvo for use in Australia.
This is not the first contribution made by Barwon Health to the development of RSV vaccines. Earlier this year Barwon Health’s Adrian Costa Clinical Trials Centre (ACCTC) took part in another trial of the GSK Arexy RSV vaccine, this time for older adults. The US FDA have since approved the Arexvy vaccine, which will enable adults aged 60 years and older to be protected from RSV disease for the first time, and the vaccine is currently being evaluated by the Australian Government Therapeutic Goods Administration (TGA).