New jab to protect babies from RSV could be here next winter

Thousands of babies are hospitalised as a result of RSV every year, but there is hope as a new immunisation is one step closer to being approved.

Babies are in line for a new lifesaving jab next winter to protect them from the deadly Respiratory Syncytial Virus (RSV).

A new immunisation for RSV — a common cold virus — has just been ticked off as safe and efficacious by the European Committee for Medicinal Products for Human Use (CHMP), an important step towards its approval for use in that continent.

The CHMP is similar to Australia’s Therapeutic Goods Administration.

The approval came after after clinical trials showed it to be 80 per cent effective at preventing severe infections and hospitalisation.

And pharmaceutical company Sanofi, which is marketing the immunisation with AstraZeneca, said it would apply to have the product approved by Australia’s TGA later this year.

The single-dose product, called Nirsevimab, is a long-acting antibody given at birth and designed to protect babies from RSV during their first year of life.

Henry, from rural Victoria, was admitted to hospital several times in 2022. Picture: Supplied

Wesfarmers Centre of Vaccines and Infectious Diseases’s Professor Peter Richmond took part in the clinical trials of the drug in babies.

“I certainly think this would be a game changer in terms of preventing children ending up sick in hospital with severe infections in over winter.

“Ideally, we could have it before next winter. That would be fantastic,” Prof Richmond, who heads the trials centre, said.

Alongside the flu, RSV is the main reason for children going to hospital for a respiratory virus and thousands of toddlers are hospitalised every year.

This year, it became a notifiable disease and this year more than 80,000 cases have been recorded around Australia.

• NSW has recorded 44,540 cases of RSV so far this year.

• Victoria has recorded 25,070 cases of RSV so far this year.

• Queensland recorded 28,747 cases this year including 3077 hospitalisations — 2534 of those were children aged under four years of age.

• South Australia recorded 8416 cases of RSV in 2022, with 62 per cent occurring in those under the age of five.

• Tasmania has had 3492 notifications of RSV since July, and just under half those were young children.

Dr Nusrat Homaira, an RSV expert from University NSW. Picture: Supplied

“RSV is the main cause of bronchiolitis in children, breathlessness and cold like symptoms and 80 per cent of children before the age of two years will have an episode,” said Dr Nusrat Homaira, an RSV expert at the University of NSW.

“Almost 40 to 50 per cent of children who develop the first episode of RSV in the first six months of their life need to come to the emergency department or be hospitalised.”

Her research has found one in 10 children who develop severe RSV disease in the first year of their life will go on to develop asthma and that risk persists for at least seven years.

If the TGA ticks off on the new jab’s safety and efficacy it would have to be recommended by the Australian Technical Advisory Group on Immunisation (ATAGI) and funded by the federal government.

Henry suffered severe heart and breathing problems caused by RSV. Picture: Supplied

One-year-old Henry experienced heart damage after catching the virus, which his mother Hannah feared would claim his life.

During his hospital stay, he turned blue, his heart rate soared and his oxygen levels plunged.

“I was really, really, really scared. When his heart rate was stuck at 215 I didn’t know what was going to happen. I didn’t know if he would have a heart attack,” she said.

“I always walked out of the room if I was going to cry. I didn’t want to let him see how much it hurt me watching him go through this.”

She said every child in the Ballarat ward with Henry was there for RSV, many of them hooked up to life saving feeding tubes, cannulas and monitors.