The European Medicines Agency (EMA) announced on Monday that it was launching its evaluation for a possible authorization of the Pfizer / BioNTech vaccine in children.
An announcement that comes three days after the transmission by the pharmaceutical laboratory of clinical trial results of their vaccine against Covid-19 in 5-11 year olds.
“The EMA Committee for Medicinal Products for Human Use (CHMP) will review the data on the vaccine, including the results of the ongoing clinical study (…), in order to decide whether to recommend an extension of its use, ”the public health agency said.
A decision in the coming months
If, for the moment, no vaccine has yet been authorized for use for this age group, this decision by the EMA should be made "in the coming months, unless additional information is necessary", she clarified.
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The decision to authorize, or not, the use of the vaccine will then depend on the European Commission, which is authoritative for all the countries of the European Union.
It is then up to them to administer it to their population.
The vaccine well tolerated in children, according to Pfizer
Pfizer and BioNTech recently claimed that their vaccine was well tolerated by 5-11 year olds and elicited a "robust" and "comparable" immune response to that seen in young adults aged 16 to 25, despite a dosage three times lower. .
It is in this sense that the laboratory requested approval for this age group in the United States at the beginning of October.
A first meeting of the Food and drugs administration (FDA) is expected at the end of October.
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In Israel, thanks to a special authorization, children under 12 most vulnerable to Covid-19 can already be vaccinated since August 1 with Pfizer, even if its use is still not formally recommended.
The Moderna laboratory, for its part, has also been conducting clinical trials on thousands of children aged 6 months to 11 years since last March.