New formats needed 
Clinical trial data released this year in a study of cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth showed that using lenacapavir results in a 96% 
‘In my view, it’s analogous to dispensing a new drug that you haven’t come across before. You understand the relevant information related to the drug from a safety and effectiveness point of view, you communicate with the patient regarding relevant counselling points, and you document relevant information.’
With cases of Respiratory syncytial virus (RSV) spiking this year, the federal government announced yesterday (10 November) that free vaccination would be offered to eligible pregnant people and babies.
Before the 2025 winter season, the RSV vaccine will be available under the National Immunisation Program (NIP) for all people in the third trimester of pregnancy via the Australian Infant RSV Immunisation Program.
Which RSV vaccines will pharmacists administer?
The RSV immunisation program will offer two Therapeutic Goods Administration approved protections against severe RSV.
Pharmacists can administer the maternal vaccine, Abrysvo, to pregnant women between 28-36 weeks of gestation.
Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%, a spokesperson from the Department of Health and Aged Care told Australian Pharmacist.
‘This is [through] passive protection by transplacental transfer of RSV-specific antibodies from the mother to the foetus during pregnancy.’
How popular will it be?
Federal Minister for Health and Aged Care Mark Butler said the RSV vaccine rollout has been modelled on the whooping cough vaccine in pregnant women, which is administered at around the same time and has an uptake rate of around 80%.
‘Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%.’
The Department of Health and Aged Care
‘So we have good confidence that there will be a significant uptake of this maternal vaccine by pregnant Australian women,’ he added.
What is covered for pharmacists under the NIP?
According to the Department of Health and Aged Care, both the cost of the maternal RSV vaccine (Abrysvo) and the vaccine administration fee will be covered under the NIP and The National Immunisation Program Vaccinations in Pharmacy (NIPVIP) Program.
Abrysvo NIP vaccine stock will also be available to community pharmacists, said the spokesperson.
What about protection for neonates?
Access has also widened for more babies to receive a protection against RSV soon after birth, particularly those whose mother did not opt to have the vaccine during pregnancy.
Beyfortus (nirsevimab), an antibody therapy for the prevention of RSV-related lower respiratory tract disease, will be available in hospitals, immunisation clinics and general practices for infants before or during their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease throughout their second RSV season can also access the vaccine.
‘Beyfortus is a monoclonal antibody treatment which is administered to babies by injection,’ said Minister Butler. ‘[It can be received] immediately after birth … if their mother has not been vaccinated against RSV.’
Why did the government decide to take action against RSV?
Australia recorded the highest ever number of RSV cases this year, with 165,910 reported notifications.
Most cases were recorded in the 0–4 age cohort, among whom RSV can be fatal, and is the leading cause of hospitalisation for Australian children under five years of age.
The Australian Immunisation Foundation estimates that around 12,000 Australian babies aged 12 months or younger are admitted to hospital with RSV annually. Around 25% of these children will require intensive care.
The inclusion of an RSV vaccine in the NIP is an important step to protect newborn children and infants from severe RSV infection, said the spokesperson.
‘The highest rate of RSV-related hospitalisations is in infants during their first few months of life,’ said the spokesperson.
‘Infants with medical risk factors, such as being born very [premature], under 32 weeks gestational age, have an increased risk of severe disease.
‘Up to 80% of infants who are hospitalised due to RSV are otherwise healthy children with no predisposing conditions.’
What’s the expected impact?
The Immunisation Foundation of Australia has estimated that the nationwide availability of new RSV immunisations will help to keep 10,000 infants out of hospital with related bronchiolitis or pneumonia each year.
‘The immunisations being funded in Australia protect babies against severe RSV and have been shown to slash hospitalisation rates by up to 90 per cent,’ said Catherine Hughes AM, Founder and Director of the Immunisation Foundation of Australia.
Western Australia was the first state to implement an infant RSV immunisation program with Beyfortus. More than 23,000 infants received RSV protection this year, resulting in up to 84% fewer hospitalisations in immunised newborns compared to those who were not RSV protected. In Queensland, where a statewide infant RSV immunisation program commenced in April 2024, similar results were observed.
‘The exceptional results in Western Australia and Queensland contrast sharply with other parts of Australia where hospitals were overwhelmed by babies struggling to breathe due to severe RSV,’ she said.
Will older patients be able to receive the RSV vaccine under the NIP?
No. Well at least, not yet.
Vaccines can only be listed on the NIP after a positive recommendation from the Pharmaceutical Benefits Advisory Committee’s (PBAC) as required by the National Health Act 1953, said the spokesperson.
‘Several vaccine sponsors have made submissions in relation to RSV vaccines for older populations to the PBAC to consider for NIP listing,’ said the spokesperson.
‘The outcomes of these meetings will inform future government considerations regarding the potential listing of RSV vaccines on the NIP for older Australians.’
While a positive PBAC recommendation is an essential requirement in the NIP-listing process, other steps need to be completed before a vaccine can be given final approval for NIP listing, said the spokesperson.
‘These include negotiations with the relevant pharmaceutical company, finalisation of conditions for listing, quality and availability checks and final consideration by the government,’ said the spokesperson. ‘These considerations and decisions of government cannot be preempted.’
