Milan, June 8 (beraking latest news Health) – The European drug agency EMA has begun evaluating the request presented by the American Moderna, to extend the use of its anti-Covid mRna vaccine to adolescents between the ages of 12 and 17. This was announced by the EU regulatory body, explaining that the Committee for Medicinal Products for Human Use (CHMP) will conduct an accelerated evaluation, at the end of which the agency will communicate the outcome of its evaluation, “scheduled for July – reads a note – unless additional information is needed “.
Moderna’s Covid-19 vaccine – recalls the EMA – has been authorized in the EU since last January for use in people aged 18 and over. In their accelerated assessment of the possibility of extending its use to 12-17 year olds, the CHMP experts will examine the data presented by Moderna in its request, including the results of a large ongoing clinical trial involving adolescents in this age group. The trial was conducted in accordance with Moderna’s Pediatric Investigation Plan (Pip) for the anti-Covid vaccine, approved by the Ema Pediatric Committee (PDCO).
The CHMP opinion on the extension of use of the vaccine, together with any requirements for further studies and additional safety monitoring – reports the EMA – will be sent to the European Commission which will issue a final legally binding decision, applicable in all Member States. of the EU.
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