Medicines agency gives green light for vaccination of 12- to 15-year-olds

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Covid-19 vaccine from Biontech/Pfizer will also receive approval in the EU for this age group.

As expected, the Corona vaccine from Biontech/Pfizer (“Comirnaty”) will also receive approval in the EU for the 12- to 15-year-old age group. This was decided by the responsible EU medicines authority EMA in Amsterdam on Friday. The responsible committee for human medicine of the EMA had spoken out in favor of the extension of the approval in an extraordinary meeting. This means that the drug can be administered from the age of 12. Formally, the approval still has to be granted by the European Commission. However, this is considered a mere formality.

Currently, the vaccine is only approved in the EU from the age of 16. In the U.S. and Canada, the age group of 12 to 15 years is already vaccinated.In the U.S., more than 600,000 children and adolescents in this age group have already been immunized.

“We have data that the vaccine is safe for 12- to 15-year-olds as well,” said Marco Cavaleri, head of the EMA’s Biological Health Risks and Vaccination Strategies Division, Friday afternoon. “The immune response is as good or even better than in young adults. Extending protection with this vaccine to a younger age group is an important step in the fight against the pandemic.” In general, he said, the side effects are similar to those seen in younger adults, and there are no major safety concerns.