Health practitioners are being urged to ensure they understand the different types of respiratory syncytial virus (RSV) vaccines and who they can be administered to, after some patients in Western Australia received the wrong vaccines.
While the WA Health Department did not provide exact numbers as to how many patients had been given the incorrect vaccines, it confirmed that 0.07% of the RSV immunisations provided in the state throughout a four-month period this year were delivered incorrectly.
The different RSV vaccines available in Australia are approved for use in certain patient groups, including babies.
The WA Health Department did not say whether those who received incorrect vaccines in WA were babies or adults.
The Therapeutic Goods Administration issued advice on June 23 that, “in response to reports we have received about administration errors related to RSV prevention products.”
As of June 13, nationally, there had been 90 reports of “administration errors” related to the three relatively new RSV prevention products.
The TGA’s advice said it reminded prescribers and vaccination providers that each of these were “specifically indicated for different patient groups.”
It advised that Arexvy is to be used to prevent lower respiratory tract disease in individuals aged 60 years and older, or those aged 50–59 years who are at increased risk of RSV disease.
Abrysvo, which this year was added to the National Immunisation Program, is given to pregnant women to prevent lower respiratory tract disease caused by RSV in their infants from birth through to 6 months of age.
The TGA’s advice said Abrysvo was also approved for use in individuals aged 60 years and older.
It outlined that Beyfortus (nirsevimab) is given to infants and children to prevent RSV lower respiratory tract disease.
WA became the first State in the country to provide free RSV immunisation to infants in 2024 when it rolled out its vaccination program to administer Beyfortus .
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The TGA said the incorrect vaccinations were thought to have occurred due to administration errors.
“An administration error generally occurs when one of these products is given outside the indications approved by the TGA,” it noted.
The mistakes included 24 reports of Arexvy being given in pregnancy, 24 reports of Abrysvo being administered to children less than 12 months old and 36 reports of Beyfortus being administered to females aged 15–54 years.
While WA Health is not aware of any “adverse events” from local cases where administration errors occurred, the TGA noted some adverse reactions were reported in some of the patients in Australia that received incorrect vaccines.
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For the reports of Arexvy being given during pregnancy, the TGA received five reports where an adverse event was also reported following vaccination.
Fatigue, lethargy, pain at the vaccination site, shortness of breath and a single report of chest pain were among the adverse effects experienced following the administration errors.
For Abrysvo being given to newborns and infants, there were four reports of adverse events that included irritability, sleepiness, fever, and rash; a single report of vomiting; and a single report where the baby had an increased heart rate and increased breathing rate.
The TGA also pointed out an administration error “may lead to various problems, including unknown levels of protection for vaccine recipients.”
Immunisation Foundation of Australia director Catherine Hughes said the errors were concerning.
“We urge the Department of Health and vaccine manufacturers to collaborate on clearer, more consistent information and training for all immunisation providers,” she said.
“Ensuring the right vaccine is given to the right patient is paramount for public safety and maintaining confidence in immunisation programs.”
WA Health’s Chief Health Officer, Andrew Robertson, said the WA community could be confident that the maternal and infant RSV immunisation programs were “safe and effective – and the best way to prevent babies from ending up in hospital very sick with RSV.”
Dr Robertson said WA Health remained committed to the safe and effective delivery of vaccines and continued to work with immunisation providers to support best practice and safeguard public health.
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