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Thursday, December 9, 2021

EU regulator approves Pfizer vaccine for children aged 5-11

The European Medicines Agency (EMA) has approved the Pfizer/BioNTech Covid-19 vaccine for children aged 5-11.

The EMA has already approved the vaccine for everyone over the age of 12. The EMA said today that the dose of the vaccine will be lower in children.


It is advised that the vaccine be administered in two doses, three weeks apart.

The Pfizer vaccine has already been approved for use in the 5-11 age group in the US.

The EMA said in a statement: “The most common side effects in children aged 5 to 11 are similar to those in people aged 12 and above. They include pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills. These effects are usually mild or moderate and improve within a few days of vaccination.”


“The EMA’s human medicines committee therefore concluded that the benefits of the Comirnaty (Pfizer) vaccine in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe Covid-19.”

The move must be considered and approved by Ireland’s National Immunisation Advisory Committee (NIAC) before the vaccine is rolled out to the younger age group.

IMAGE – “201214-D-BN624-0811” (CC BY 2.0) by U.S. Secretary of Defense


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