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European Medicines Agency begins evaluating Pfizer vaccine for children 5 to 11 years old

The European Medicines Agency (EMA) today announced the beginning of the evaluation of the Pfizer-BioNTech vaccine against COVID-19 for children between 5 and 11 years old.

Comirnaty, the Pfizer-BioNTech vaccine, has currently been authorized by the European Commission to be injected in people over 12 years of age since last May.

The Committee for Medicinal Products for Human Use of the EMA will review “the results of an ongoing clinical study with children ages 5 to 11 to decide whether it is recommended to extend its use,” the regulatory body said in a statement.

The EMA it expects to communicate the conclusions of its evaluation within two months “unless additional information is needed,” he said.

Subsequently, the recommendation will be sent to Brussels for the European Commission to evaluate authorizing its marketing in the EU.

The vaccine Pfizer-BioNTech It was the first approved in the European Union for people over 18 years old, on December 21, 2020, and its use was extended to adolescents from 12 years old on May 28.

If approved by the regulatory body, Comirnaty would be the first licensed vaccine for children aged 5 and over in the EU.

On the other hand, the EMA approved today that the solution of Pfizer-BioNTech be manufactured in two new plants in Italy, one in Monza, in the north of the country, and the other in Anagni, near Rome.

Both factories are expected to supply the EU with an additional 85 million doses in the remainder of 2021.


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