Do not give FluMist to under-2s, TGA warns

The Therapeutic Goods Administration (TGA) has issued a warning not to administer the widely subsidised FluMist vaccine to children aged under two, following a series of adverse event notifications.
 
The needle-free vaccine, which is delivered via a nasal spray, has been introduced this year as part of state-government-funded programs in New South Wales, Queensland, South Australia and Western Australia.
 
It is indicated by the TGA for flu prevention in children and adolescents aged from 24 months to less than 18 years, although ages covered by the state-funded programs vary widely.
 
In an alert issued last Friday, the TGA flagged more than 100 reports already where the vaccine has been given to children aged less than two.
 
In a search of the Database of Adverse Event Notifications (DAEN) for ‘FluMist’, the regulator found 161 adverse event reports in May, with 116 involving children aged one or younger.
 
These included 89 reports stating the product was given to a patient of inappropriate age, 38 saying the wrong product was administered, four describing a ‘vaccination error’, three reporting an ‘inappropriate schedule of product information’, and one listing ‘product label confusion’.
 
The data does not state which health professionals delivered the vaccinations, or whether there were any further adverse effects.
 
The TGA noted that none of the reports was classified as serious but urged health professionals to confirm children are aged two years or older before administering the vaccine, as well as to check the product information on the TGA website. 
 
It also referred to initial research suggesting why the vaccine may not be approved for infants.
 
‘Early clinical trial data indicated increased rates of hospitalisation in children aged 6–11 months and wheezing in children aged 6–23 months following vaccination,’ the regulator stated.
 
For Dr Kerry Hancock, Chair of RACGP Specific Interests Respiratory Medicine, the TGA warning is a timely reminder for a vaccine that is likely to be used widely this year.
 
‘It’s only TGA-approved for [the 2–17] age group and we need to ensure that’s the age group that gets it, that it’s not inappropriately administered to children less than two years of age,’ she told newsGP.
 
She believes some vaccinators may encounter pressure from parents, but points out that injectable flu vaccinations are widely available for children aged under two, with the nasal-spray vaccine more likely to help school-age children.
 
‘To me, it’s the older children who are a bit more frightened of needles,’ she said.  

‘To be able to offer that age group, especially the primary school and high school age groups, a nasal vaccine is just phenomenal.’
 
A search of the DAEN on 9 June also found five reports of older patients being administered the vaccine in error, all of whom were aged 45 or older.
 
The vaccine is not currently listed under the National Immunisation Program (NIP) but is available privately in jurisdictions where no subsidies have yet been put in place.
 
The RACGP recently called for the Victorian Government to join other areas in funding the vaccine, which has been credited with reducing hesitancy and increasing uptake in countries where it is already in widespread use.
 
Dr Hancock said she would like to see the vaccine on the NIP for those aged 2–4, and for state governments to consider funding older age groups where they do not already.
 
‘If we’ve got that evidence, why don’t we put that into action?’ she said.
 
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FluMist influenza vaccination vaccines