EMA is evaluating Moderna’s COVID-19 vaccine for children aged 6 to 11

12 November 2021

Moderna has submitted an application to the European Medicines Agency, EMA, to extend its conditional authorisation for its COVID-19 vaccine, Spikewax, to children aged 6 to 11.

Spikevax is currently authorised for use in people aged 12 years and older, and the EMA’s human medicines committee (CHMP) is now going to assess if the conditional authorisation should be extended to children aged 6 to 11. This assessment will include results from clinical trials involving children aged 6 to 11.

Once the EMA has made its recommendation, the European Commission then formally decides whether to follow the recommendation and authorise the vaccine for this age group in the EU.

In Denmark, the Danish Health Authority decides which vaccines are to be included in the Danish vaccination programme and which age groups are to be offered the vaccines.

Links

Press release of the EMA

More information about the Spikewax vaccine

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