EU regulator decides this Thursday on use of Pfizer vaccine in children up to 11 years old

The European Medicines Agency (EMA) will issue its decision on Thursday on the administration of the BioNTech/Pfizer anti-covid-19 vaccine to children from five to 11 years old, which could be the first in the European Union (EU) for this age group .

EMA official source informed Lusa that an extraordinary meeting of the Committee for Medicines for Human Use will take place this Thursday to “discuss the evaluation of this request to extend the use of Comirnaty in children”.

“If the committee reaches an opinion, we will communicate about the matter, most likely by the end of the afternoon”, the same official source of the European regulator told Lusa.

The Committee for Medicinal Products for Human Use is responsible for preparing the EMA opinions on all drug-related issues and has been studying, since mid-October, the use of the anti-covid-19 Comirnaty vaccine (brand name for the vaccine from the pharmaceutical consortium BioNTech/ Pfizer) in children aged between five and 11 years.

To be approved for this use, it will be the first vaccine in the EU for children in this age group, at a time when there are increases in cases at these ages and when the United States is already administering it.

Currently, the Comirnaty vaccine is authorized from the age of 12, after being approved for the first time in December 2020 for adults in the EU.

The Committee for Medicinal Products for Human Use has been reviewing data on the vaccine, including the results of a clinical study involving children aged five to 11 years, to decide whether or not to recommend extending its use.

The opinion will then be sent to the European Commission, which will issue a final decision.

This vaccine relies on messenger RNA technology, with instructions to make a protein that is naturally present in SARS-CoV-2, the virus that causes Covid-19, thus preparing the body to develop the infection.

On Tuesday, the Portuguese Society of Pediatrics considered that vaccines against Covid-19 are safe in the age group from five to 11 years old, but argued that the decision to vaccinate should take into account other data, such as the prevalence of the infection in kids.


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