A MISLEADING CLAIM has been shared on social media suggesting that the flu vaccine given to children has not been authorised for use in Ireland.
The claim has spread in recent days and says that Ireland’s Health Products Regulatory Authority (HPRA), which regulates medicines in Ireland, has not authorised the vaccine.
However, posts with the claim have missed out important information about the authorisation process for medicines and vaccines in Ireland and across the EU.
The claim originated on Twitter on 15 November with one social media user sharing a photo of a letter from the HPRA.
In the caption, the Twitter user wrote: “So now we discover that the Fluenz Tetra nasal flu vaccine (being given to our young children right now) has NOT been authorised by the Health Products Regulatory Authority (HPRA).”
“I repeat it has NOT been authorised by HPRA,” the user wrote.
The tweet has been retweeted and quote tweeted 247 times and liked 285 times in the last four days.
The tweet has been screenshotted and shared to other social media platforms where it has gained traction, including Facebook.
One version of the post on Facebook, which is captioned “poor children”, has been viewed 16,400 times since 16 November.
The image in the post is a photo of a letter sent from the HPRA responding to a question about the vaccine.
The letter says:
Fluenz Tetra (influenza vaccine, live attenuated, nasal) is authorised by the European Commission for use in all Member States in the European Union since 2013 for prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age (EU number: EU/1/13/887).The European Medicines Agency (EMA) assessed Fluenz Tetra to recommend its authorisation in the EU Commission and its condition of use. Further information on the EMA assessment is available from the European public assessment report (EPAR), which is publically [sic] available on the EMA website, together with additional product information and a history of the EMAs further assessments since the time of initial authorisation.In conclusion, the vaccine was not authorised through the HPRA.”
The vaccine was authorised through the central European authorisation system for medicines.
When vaccines are authorised at a European level, the decision is valid and legally binding in all EU member states, which means that the vaccine is approved for use in Ireland.
Speaking to TheJournal.ie, a spokesperson for the HPRA said that the letter was “intended to clarify that the Fluenz Tetra vaccine was authorised through the central European authorisation system”.
The spokesperson said that before medicines are made available on the market, they must first be authorised in line with regulations.
“Medicines, including vaccines, will only be authorised once the data submitted to the regulators meets all the requirements of quality, safety and efficacy (effectiveness),” the HPRA said.
“Medicines in Ireland are typically assessed at either a national or decentralised level, where an Irish market authorisation is granted by the Health Products Regulatory Authority (HPRA), or at a European level, where a centralised assessment is carried out by the European Medicines Agency (EMA) and the authorisation granted by the European Commission,” they said.
“Once the European Commission grants a marketing authorisation for a medicine, this is valid and legally binding across all EU member states, including Ireland.”
The HPRA, as Ireland’s national medicines regulator, is an active participant in all new product assessments carried out by the EMA and also contributes directly to the safety monitoring of all new medicines once in use.”
Fluenz Tetra first received authorisation for use across the EU by the European Commission in 2013.
It is used for children and teenagers between the ages of 24 months and 18 years and is administered as a nasal spray.
This year, children in Ireland between the ages of 2 and 12 are able to avail of the vaccine for free.
It is a live attenuated vaccine, which means that it is made with influenza viruses that are weakened in a way such that they cannot cause an influenza infection.
Rumours often spread that children who receive the flu vaccine can cause a flu infection in people they come into contact with.
In fact, children who receive the vaccine can shed the weakened virus in the vaccine for a few days after they receive it, but the weakened virus does not cause disease in the person who receives the vaccine or any other person.
The HSE has said that since the vaccine was first licenced, there have been no reported cases of influenza passing from children who received a vaccine to members of their families or close contacts.
The vaccine in use during the 2020/21 flu season contains no aluminum, mercury, or thiomersal, which are often mentioned in anti-vaccination social media posts.
Posts shared on social media in recent days have claimed that Fluenz Tetra, a flu vaccine given to children as a nasal spray, was not authorised by the Health Products Regulatory Authority.
In fact, the vaccine was authorised through the central European authorisation system, where it was assessed by the European Medicines Agency and granted authorisation by the European Commission.
The HPRA works with the European Medicines Agency during new product assessments and helps to monitor the safety of new medicines once they are in use.
As a result, we rate the verdict that the Fluenz Tetra vaccine has not been authorised by the HPRA: MISLEADING.
As per our verdict guide, this means: The claim either intentionally or unintentionally misleads readers.
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