RSV vaccine Arexvy, trialled in Geelong, approved by US DFA

A vaccine for a common respiratory virus has been approved for use in America after being trialled on Geelong region residents.

Research operations manager Bree Sarah, clinical trial manager Kate Ellis, and research participant Margaret Lourey at Barwon Health’s Adrian Costa Clinical Trials Centre. Picture: Alan Barber

A vaccine for a common respiratory virus has been approved for use in America after being trialled on Geelong region residents.

Barwon Health’s Adrian Costa Clinical Trials Centre recently collaborated with pharmaceutical and biotechnology company GSK on the world’s first respiratory syncytial virus (RSV) vaccine for older adults.

The United States Food and Drug Administration recently approved the new vaccine, known as Arexvy, which was trialled around the world.

The approval will enable adults aged 60 and older to be protected from RSV disease for the first time.

The US launch is planned ahead of the country’s 2023/24 RSV season.

The Therapeutic Goods Administration confirmed it was evaluating an application received in January to register the Arexvy RSV vaccine.

“TGA approval depends on the data presented by the company that demonstrates it meet the Australian regulatory requirements for safety, quality and efficacy,” a spokesperson said.

Tony Wood, chief scientific officer at GSK, said it was focused on ensuring eligible older adults in the US could access the vaccine as quickly as possible and progressing regulatory review in other countries.

As part of the trial, 26 local volunteers participated over the last two years.

Participants were given one vaccination at the start of the study and then an annual booster.

They are still being monitored to see if they develop any respiratory illnesses.

Older adults are at high risk for severe RSV due in part to age-related decline in immunity. Older adults with underlying conditions are at even greater risk for severe disease.

The contagious virus can exacerbate conditions including chronic obstructive pulmonary disease, asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.

Local trial participant Margaret Lourey said knowing she had been a part of helping to produce a vaccine that would help people across the world was really exciting.

“The team here at the clinical trials centre have been wonderful and I’ve found it to be such a rewarding experience,” she said.

Professor Eugene Athan

Barwon Health’s Professor Eugene Athan said there had been about 2380 recorded cases of RSV over the past 12 months in the Barwon South West region.

“Our community’s participation was integral to this trial’s success,” he said.

Barwon Health clinical trial manager Kate Ellis said International Clinical Trials Day, this Saturday, was a celebration of the achievements of modern medicine.

“The research teams here at Barwon Health have a long history of running successful clinical trials, and this latest vaccine is just another example of how important clinical trials are in the discovery of new vaccines and other treatments,” she said.

“Over the past 20 years our teams have led many clinical trials that have gone on to save many lives.”

Originally published as RSV vaccine Arexvy, trialled in Geelong, approved by US DFA