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A world-first study has found a new vaccine against potentially deadly respiratory syncytial virus (RSV) is safe and effective for use in pregnant women, to help protect their babies.

The phase-3 clinical trial in 18 countries, including Australia, found the Pfizer RSVpreF vaccine helped protect newborns from lower respiratory tract infections caused by RSV – one of the leading causes of hospitalisation for babies globally.

RSV is responsible for more than 100,000 deaths and 3.6 million hospitalisations in children around the world each year.

It infects the airways and lungs and can lead to life-threatening complications such as bronchiolitis and pneumonia.

A paper published in the prestigious New England Journal of Medicine found the vaccine, given to women who were between 24 and 36 weeks pregnant, gave their babies protection from severe RSV for up to 180 days after birth.

Professor Peter Richmond, Head of the Vaccine Trials Group at the Wesfarmers Centre of Vaccines and Infectious Diseases, based at the Telethon Kids Institute, Head of Paediatrics at The University of Western Australia and Head of Immunology at Perth Children’s Hospital, said the trial also found the vaccine to be safe for mums and their unborn babies.

“There was a significant spike in the number of RSV cases in Australia last winter as we were coming through COVID, and we know that the highest risk age group for RSV is babies in the first two to three months of life,” Professor Richmond said.

“The findings of this study are really significant in the fight against RSV in Australia."

Telethon Kids Institute was the lead site in Australia for the study.

Currently, there is no vaccine against RSV suitable for babies, but Professor Richmond said a long-lasting monoclonal antibody treatment for babies was likely to be on the market within 12 months.

“As a paediatrician who has looked after sick babies with RSV for more than 30 years, the idea that we could prevent a large proportion of these illnesses is fantastic and I feel privileged to have been involved in the process,” he said.

“I believe the potential burden of disease we may be able to prevent will be even greater than first thought, including decreasing the amount of antibiotics that are prescribed, reducing ear infections in young babies and decreasing more serious bacterial pneumonias that are associated with RSV infection.

“There is also the potential benefits of preventing longer-term complications such as chronic lung infections and asthma.”

Professor Richmond said a suite of potential vaccines for RSV was exciting news for parents in Australia and overseas.

“In the next 10 years I hope to see licensed vaccines and preventative drugs being given to mothers, babies, toddlers and older adults, with multiple vaccine and monoclonal antibody platforms available that could even be combined with COVID and influenza vaccines, helping keep our hospitals and GP surgeries much quieter over winter.

“The biggest challenge will be ensuring these vaccines are accessible and affordable in low and middle-income countries where more than 99 per cent of RSV deaths occur, especially given the effectiveness shown in the large Phase 3 trials included countries across Africa, Latin America and Asia.”

Professor Richmond urged parents of newborns to be aware of the symptoms of RSV heading into winter.

“I am concerned that parents may not be aware of RSV and the pivotal role it plays in serious infections in young children,” he said.

“If you have any concerns about your baby if they have difficulties with breathing or feeding, please don’t hesitate to seek medical advice.”

For more information about RSV research by the Wesfarmers Centre of Vaccines and Infectious Diseases or to register your interest for upcoming studies, please visit infectiousdiseases.telethonkids.org.au or email vtg@telethonkids.org.au