Health Minister Stephen Donnelly has said the EMA’s decision is “very good news”.
The European Medicines Agency (EMA) has approved the use of the Pfizer/BioNTech Covid-19 vaccine in children aged between 12 to 15.
It is the first Covid-19 vaccine to be approved for children in that age group in the European Union. The Pfizer vaccine is already approved for use in adults and teenagers aged 16 and above.
The use of the vaccine in children aged 12 to 15 will be the same as it is in people aged 16 and over.
Its effects were investigated in 2,260 children between 12 and 15, with a trial showing that the immune response to the vaccine in this group was comparable to the immune response in the 16 to 25 age group.
Nearly 2,000 children from 12 to 15-years-old with no sign of previous infection were either given the vaccine or a placebo.
Of the 1,005 children who received the vaccine, none developed Covid-19, compared to 16 children out of the 978 who received the dummy injection.
In a statement, the EMA concluded: “This means that, in this study, the vaccine was 100% effective at preventing Covid-19 (although the true rate could be between 75% and 100%).”
The most common side effects of the vaccine in children aged 12 to 15 are similar to those in people aged 16 and above and include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever.
The EMA added: “These effects are usually mild or moderate and improve within a few days from the vaccination.
“The safety and efficacy of the vaccine in both children and adults will continue to be monitored closely as it is used in vaccination campaigns across the Member States, through the EU pharmacovigilance system and ongoing and additional studies by the company and by European authorities.”
Following, the EMA’s announcement, Ireland’s Health Minister Stephen Donnelly wrote on Twitter that the approval was “very good news”.
You can read the EMA’s full statement here.
Very good news https://t.co/yaToWFKQNR
— Stephen Donnelly (@DonnellyStephen) May 28, 2021
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