Newborns to wait on new jab to protect against RSV

Newborns in Victoria will miss out on protection from the potentially deadly RSV this winter despite a new long-lasting treatment being approved for use in Australia.

Victorian newborns will miss out on protection from the potentially deadly and highly contagious respiratory syncytial virus (RSV) this winter – despite a new effective, safe and long-lasting “vaccine” being approved for use in Australia.

RSV spreads easily through coughs and sneezes and most children will be infected by the virus before the age of two. It can be serious, hospitalising around 12,000 babies every year in Australia.

This new one-off injection, sold as Beyfortus, has been rolled out in the US and Europe following successful clinical trials that showed it helped reduce hospitalisation of babies from the virus by as much as 83 per cent.

Beyfortus was approved by the Therapeutic Goods Administration in November, but is not yet funded under the Pharmaceutical Benefits Scheme (PBS) or added to the national immunisation program (NIP).

The new jab has been rolled out in the US and Europe following successful clinical trials showing it reduced hospitalisations by as much as 83 per cent. Image: Picture: istockphoto

These decisions can take several years and are the responsibility of the federal government relying on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC) on which drugs to list on the PBS or NIP.

State governments have previously stepped in to fund some vaccines including the flu vaccines, meningococcal and pertussis (whooping cough) in pregnancy so they are available earlier.

On Tuesday the Western Australian Government became the first in the southern hemisphere to agree to a state-funded immunisation program using Beyfortus after an agreement with distributor Sanofi.

Several other states are said to be close to supply agreements, but Victoria is not thought to be one.

University of Melbourne Emeritus Professor Terry Nolan at the Doherty Institute said there was evidence to show Beyfortus worked “extremely well” in babies. Picture: David Caird

University of Melbourne Emeritus Professor Terry Nolan at the Doherty Institute said there was good randomised trial evidence to show Beyfortus worked “extremely well” in babies.

“This product has now been implemented in the US and Europe in their current winter, and early figures from Spain have shown a huge reduction in hospitalisation in babies just as the clinical trials suggested there would be. It is being seen in real life. It is very unusual with any new vaccines to show an effect so quickly and so dramatically,” he said.

Prof Nolan said Beyfortus was not a vaccine in the usual sense.

“It is providing immunity to the baby, but it is giving long-acting monoclonal antibodies instead of something to stimulate the immune system,” he said.

RSV can be serious, hospitalising around 12,000 babies every year in Australia. Image: Supplied.

Prof Nolan said it was a new form of immunisation that retained its activity for up to nine months.

“That is the big technical advance,” he said.

Prof Nolan said proper evaluation of this product should occur.

“Because the evidence is so good, I would welcome state governments funding this as the federal government proceeds through the normal process of whether or not it will be publicly funded through the PBS or NIP,” he said.

“I am certainly in favour of it, and I would welcome the Victorian Government favourably considering funding.”

On Tuesday afternoon the West Australian chair of the Royal Australian College of General Practitioners Dr Ramya Raman said she welcomed the decision by the Western Australian Government to fund Beyfortus and was now calling on other states and territories to follow suit.

At a glance

• Beyfortus is the first long-lasting RSV protection for babies under eight months

• It is best administered as an injection soon after birth or during a baby’s first RSV season (winter)

• Babies under six months are most likely to develop severe symptoms, including lung infections such as bronchiolitis and pneumonia

Originally published as Newborns to wait on new jab to protect against RSV