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EMA approves second vaccine for children aged 12 to 17 in EU

Children aged 12 to 17 years across the European Union are now eligible to receive pharma company Moderna’s COVID-19 vaccine, Spikevax, after a decision from the European Medicines Agency (EMA).

Spikevax has been investigated in a study involving almost 4,000 children aged 12 to 17 years. The study showed that Spikevax produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years. 

The study found that the most common side effects in children aged 12 to 17 are similar to those in people aged 18 and above. Some of the side effects are pain and swelling at the injection site, tiredness, headache, muscle and joint pain. Side effects are usually mild or moderate and improve within a few days from the vaccination.

The EMA’s human medicines committee CHMP noted following its approval on Friday (23 July) that the trial could not have detected new uncommon side effects due to the limited scale of the study. It also could not estimate the risk of known side effects such as myocarditis – inflammation of the heart muscle,  and pericarditis – inflammation of the membrane around the heart.

However, the overall safety profile of Spikevax determined in adults was confirmed in the adolescent study. Therefore CHMP considered that the benefits of Spikevax in children aged 12 to 17 outweigh the risks, in particular in those with conditions that increase the risk of severe COVID-19.

The use of the Spikevax vaccine in children from 12 to 17 years of age will be the same as in people aged 18 and above. It is given as two injections in the muscles of the upper arm, four weeks apart.

This is the second vaccine that was approved for children aged 12 to 17 in the EU after BioNTech/Pfizer’s ‘Comirnaty’ vaccine was approved in May.

Both vaccines approved for children so far are based on mRNA technology.

[Edited by Josie Le Blond]

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