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EU drugs regulator recommends Pfizer/BioNTech jabs for children 12-15

Clinical trials proved strong immune response for age group between 12-15 years old

Agnes Szucs   | 28.05.2021
EU drugs regulator recommends Pfizer/BioNTech jabs for children 12-15

BRUSSELS

The European Medicine Agency (EMA) on Friday authorized the Pfizer/BioNTech vaccine for use in children aged 12 and 15.

“The EMA’s Committee for Human Medicine approved today the use of vaccines from Pfizer-BioNTech, called Comirnaty, for adolescents from 12 to 15 years,” Marco Cavaleri, the head of Biological Health Threats and Vaccines Strategy at EMA, announced at a press conference in Brussels.

He explained that clinical trials with the involvement of over 2,000 adolescents proved a similar or even better immune response compared to young adults.

The side effects were also comparably mild to the ones young adults experienced after vaccination.

Upon the recommendation of the EU drugs regulator, the European Commission will modify the marketing license of the jabs, changing the youngest age of recommendation to 12 years from 16 years.

Based on the decision, the EU states will be free to decide whether to extend vaccination programs to young adolescents.

The BioNTech/Pfizer vaccine was the first COVID-19 shot authorized in the EU.

The vaccine uses an innovative mRNA technique based on a messenger molecule with instructions to produce a protein from the virus that causes COVID-19 to prepare the body to fight the disease.

Contrary to traditional vaccines, BioNTech/Pfizer does not contain the virus itself.

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