EMA starts evaluating Pfizer vaccine for children over 5 years old

EMA starts evaluating Pfizer vaccine for children over 5 years old
Credit: Belga

The European Medicines Agency (EMA) has started evaluating an application to extend the use of the Pfizer/BioNTech coronavirus vaccine to children aged 5 and over, the agency announced on Monday.

In order to decide whether to recommend extending its use, EMA’s human medicines committee (CHMP) will review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11.

The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final decision.

Whether Belgium will decide to vaccinate children under 12 years old will depend on the EMA’s evaluation, says Gudrun Briat, spokesperson for Belgium’s Vaccination Taskforce.

“Should this file be approved, it will also become accessible to the EU Member States,” she told The Brussels Times.

“In our case, the Superior Health Council will then look at the results of the study and issue an opinion based on them,” Briat added. “Then, based on that advice, the policymakers will see what will happen in Belgium.”

Currently, 12 to 15-year-olds in Belgium are already being vaccinated with the Pfizer jab if they have parental consent, following the green light from the EMA earlier this year.

The outcome of the EMA’s evaluation for children aged 5 to 11 is expected “in a couple of months, unless supplementary information is needed.”


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