Pfizer vaccine, Ema: “Yes booster to children over 12”

Green light from the European drug agency Ema to Pfizer’s anti-Covid vaccine booster also for adolescents from 12 years of age. This is what the regulatory body communicates in a note, explaining that the Committee for Medicinal Products for Human Use (CHMP) today recommended “that a booster dose of the Comirnaty vaccine * can be administered, if appropriate, to adolescents starting from 12 years of age “. The vaccine is already authorized in the EU as a 2-dose primary course in adolescents (as well as in adults and children from 5 years of age) and the booster is currently authorized from 18 years of age. The CHMP opinion on the basis of which the EMA recommended the authorization of the Comirnaty booster for the over 12s is based on the evaluation of provisional safety and efficacy data deriving from a clinical trial of a booster dose of the vaccine in children of age 16 and older, along with those from published scientific literature on the subject and post-authorization data, as well as real-world evidence from the use of booster doses in boys in Israel. to those who completed primary school “to restore protection after a decline occurs. The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults – Ema clarifies – And no new safety problems have been identified from the available data “. More data are expected from studies and analyzes on adolescents in the coming months. The EMA will continue to monitor and evaluate the evidence and “update product information or take other appropriate regulatory measures, if necessary”, assure the EU regulatory body. The agency’s decision will support national vaccination campaigns in Member States where it will be decided to offer booster to adolescents. “However – recalls the EMA – the decision if and when to offer the booster in this age group will have to take into account factors such as the spread and the level of severity of the disease (especially with the Omicron variant) in younger people, the risk known of side effects (in particular the very rare but serious complication of myocarditis) and the existence of other protective measures and restrictions. It will therefore be up to the experts who lead the vaccination campaign in each Member State to guide the decision and the choice of timing. ” The CHMP’s opinion will be forwarded to the European Commission, which will soon issue a final decision.