Pfizer, BioNTech file for vaccine approval for children aged 12-15

German vaccine maker BioNTech and its US partner Pfizer applied on Friday to the European Medicines Agency (EMA) for approval of their coronavirus vaccination for children and adolescents aged 12 to 15.

Announcing their application, the companies said the move would involve adapting and extending the existing approval to the younger age group.

Raising the number of those receiving the vaccine against Covid-19 is part of a wider effort to help to build herd immunity in the European Union community.

So far, the Pfizer/BioNTech jab has only been approved in the EU and the United States for people aged 16 and older.

The two partners have already submitted an application to the US Food and Drug Administration (FDA) to expand the vaccine’s current emergency approval to include the 12 to 15-year-old age group.

Pfizer and BioNTech recently said that a US clinical trial in the 12 to 15-year-old age group showed 100 per cent efficacy.

The vaccine was well tolerated by those taking part in the study.

Side effects were similar to those seen in the 16 to 25-year-old age group, the companies said.

Final EU approval could come in early to mid-June ahead of the start of the school year in many countries. The EMA typically takes four to six weeks to review applications for coronavirus vaccinations.

Pfizer and BioNTech are also continuing clinical trials of the efficacy and safety of their vaccine against Covid-19 in infants and children from 6 months to 11 years old.

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