RSV vaccine trialled in Geelong approved for pregnant women in US

A vaccine trialled in Geelong has been approved to be used on pregnant women in America to protect babies from a common virus.

Lauren and Georgie Tierney. When Lauren was pregnant, she was in a trial of an RSV vaccine now approved in the US.

A vaccine trialled in Geelong has been approved to be used on pregnant women in America to protect babies from a common virus.

Pfizer’s Abrysvo vaccine has been ticked off for use as the first maternal vaccine to help shield infants at birth through six months from lower respiratory tract disease (LRTD) and severe LRTD due to respiratory syncytial virus (RSV) in the US.

There are currently no RSV vaccines registered for use in Australia.

RSV causes cold-like symptoms, but infants and older adults are more likely to develop severe cases.

Bree Sarah, research operations manager at Barwon Health’s Adrian Costa Clinical Trials Centre, said the health service’s clinical trials unit had four participants enrolled in the study during 24-36 weeks’ gestation of 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.”

Lauren and Georgie Tierney. When Lauren was pregnant, she was in a trial of an RSV vaccine now approved in the US.

Participant Lauren Tierney, from East Geelong, has seen babies with RSV in her work as a nurse.

“It’s not at all pleasant,” the 38-year-old said.

She took part in the trial while pregnant with Georgie, who turned one in June.

Having a baby due in winter and a toddler – a potential source of RSV – at home were some of the factors that inspired her to sign up.

Ms Tierney described being in the trial as “so easy” and “very straightforward”.

“It’s nice to have a good outcome, you’re involved in something and you see results,” she said.

In the US Abrysvo, administered as a single dose injection into the muscle, is approved for use at 32 through 36 weeks’ gestational age of pregnancy.

A health department spokesman said the Therapeutic Goods Administration (TGA) received and commenced evaluating an application from Pfizer Australia to register the RSV vaccine, Abrysvo, in May.

“TGA approval depends on the data presented by the company, which must demonstrate the product meets the Australian regulatory requirements, particularly with regard to safety, efficacy, and quality,” the spokesman said.

“While the legislated time frame for the TGA to complete an evaluation is 255 working days, applications are generally completed before this time.”

The US Food and Drug Administration approved Abrysvo in May for the prevention of LRTD caused by RSV in people 60 and older.

Originally published as RSV vaccine trialled in Geelong approved for pregnant women in US