RSV vaccine approved by TGA

Many older Australians will soon be better protected against the highly infectious respiratory syncytial virus (RSV), thanks to a new vaccine about to hit the market.
 
This week, the Therapeutic Goods Administration (TGA) approved AREXVY for those aged 60 and over, in a decision described as a ‘turning point’ for public health.
 
While no date has been set for the vaccine’s rollout, there are hopes it will be available via private prescription before winter.
 
It also remains unclear how much the vaccine will cost patients.
 
Nonetheless, GP and National Immunisation Coalition Chair Dr Rod Pearce told newsGP it is now a case of waiting for vaccine supply to reach Australian shores and then its distribution can begin.
 
‘It’s ticking all the boxes,’ he said.
 
‘If it’s going to be less spread amongst adults, there’s less infections that the kids are going to get … and we’re not going to choke up the children’s hospitals with RSV.
 
‘If we decrease the likelihood of catching it, or if there’s a 90% reduction in the severity, then you’re going to have less severe disease and you’re going to have less likelihood of a secondary bacterial infection as well.’
 
AREXVY was first approved in the United States in May after it was ticked off by the Food and Drug Administration (FDA). The protein-based single-dose vaccine given is also available in the UK, European Union, Canada and Japan.
 
In Australia, the TGA’s approval comes after the vaccine’s manufacturer, GlaxoSmithKline (GSK), conducted an international clinical trial in which AREXVY was compared to a placebo in almost 25,000 people aged 60 or older.
 
These trials found a 94.6% efficacy rate against RSV-related lower respiratory tract disease (LRTD) in patients with at least one underlying medical condition, including cardiorespiratory and endocrine-metabolic conditions.
 
The new vaccination comes as RSV diagnoses skyrocket in Australia, with 127,944 cases reported in 2023, causing symptoms that range from mild to life-threatening.
 
This is something academic GP and Flinders University Associate Professor John Litt knows all too well, after a close friend was nearly hospitalised with the condition last year.
 
‘It was really alarming that she nearly ended up in hospital … I was surprised how quickly she became unwell,’ he told newsGP.
 
‘She has a combination puffer, inhaled steroid and long-acting bronchodilator, regularly because she’s got asthma, but she’s never ended up in hospital.
 
‘This was the most out of breath I’ve seen her, so that was scary.’
 
Associate Professor Litt now hopes the vaccine will help alleviate the significant pressure RSV is currently putting on Australia’s already strained healthcare system.
 
He said RSV can be readily diagnosed by a multiplex respiratory PCR through a nasal swab, saying a GP recommendation will likelyhave a big influence on people getting the vaccine.
 
‘If we had high levels of coverage against influenza and RSV … that will certainly take a segment of people out of hospitals,’ Associate Professor Litt said.
 
‘I did a lot of my clinical work in the ED and if we had RSV around at the same time as flu, we were absolutely flat out because we had all the kids getting flu and RSV, and quite a few of the adults and that put a huge pressure on admissions and hospital beds.

‘It’s a good vaccine. It’s important against a condition which is common and under-recognised, and I would encourage GPs, for anyone with a respiratory illness, if there’s RSV about, then they’ve got to be thinking about it.’

Dr Pearce said the vaccine also has the potential to reduce antibiotic prescriptions as patients will likely develop fewer secondary bacterial infections from RSV.
 
‘If you’ve got a less severe viral infection then there’s less chance of people having to use antibiotics,’ he said.
 
‘Antibiotic stewardship says don’t start antibiotics initially, but we know that people who get viral infections have a fair chance of getting bacterial infections.
 
‘If we don’t have severe viral infections, then we’re going to worry less about the secondary infections, and therefore, I think it will help ultimately with bacterial antibiotic stewardship.’
 
Moving forward, Dr Pearce said he would like to see the vaccine made available to different patient cohorts, including those who are vulnerable or with co-morbidities.
 
But for now, he said GPs need to ensure their eligible patients are told of the vaccine to make an informed choice about their own healthcare.
 
‘Once it’s available, and hopefully it’s here for this winter, we can then say to patients, “well, here’s another good, safe, effective vaccine”,’ Dr Pearce said.
 
‘At least if you do get it, it’s going to be mild, you’re not going to spread it to kids, you’re not going to cause asthma or pneumonia in kids.
 
‘Overall, it’s a positive step forward for Australia and it really brings us into line with the USA, the UK, and Spain.’

Log in below to join the conversation.

respiratory syncytial virus RSV TGA vaccine