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EMA begins evaluating use of Pfizer vaccine in children between 12 and 15 years old

Updated: Monday, May 3, 2021 3:54 PM

Published on: 05/03/2021 3:53 PM

The European Medicines Agency today began to assess the request of pharmaceutical companies Pfizer and BioNTech to include children between the ages of 12 and 15 in vaccination with their preparation against COVID-19, and hopes to communicate the result of the ‘evaluation around June. .

In a statement, the Amsterdam-based agency explained that the Committee for Medicinal Products for Human Use (CHMP) will conduct an “expedited assessment of the data submitted by the company that markets Comirnaty (Pfizer brand vaccine)”, including the data from a “large clinical trial in adolescents” over 12 years of age, which showed the vaccine to be 100% effective in this age group.

The use of this drug has been authorized in the European Union since December, but only in people over 16 years of age, and it is actively used in vaccination campaigns in member countries.

The EMA must determine whether the safety and efficacy criteria are maintained for the new age group between 12 and 15 years, before deciding whether or not to recommend the extension of the indication to this age group. . In a joint statement, pharmaceutical companies explained last week that they had tested their formula against the coronavirus in 2,260 adolescents in phase III and that, as they announced at the end of March, the effectiveness of the vaccine was 100% and with a “strong” immune response. In testing, they add, the vaccine was “generally well tolerated.”

The two pharmaceutical companies were the first to announce last November that their vaccine – based on BioNTech’s new messenger ribonucleic acid (mRNA) technique – was highly effective. The EMA plans to communicate the outcome of its assessment “by June, unless further information is needed” to delay the analysis process, and the CHMP will then send its findings to the European Commission for a final decision. legally binding applicable to all. EU Member States.

If approved by the EMA, it would be the first vaccine to be licensed in the EU for use in children under 16. Pfizer has also started clinical trials of its vaccine in children 6 months to 11 years old and has 144 children in age groups between 6 months and 2 years, 2 and 5 years and between 5 and 11 years. Moderna, for its part, announced that it began clinical trials of its COVID-19 vaccine in children under 12 on March 16, which began for adolescents between the ages of 12 and 17 in December.