Ema, yes to the Covid vaccine from 6 months of age: it will be recommended for fragile children

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After the green light from the American FDA last June, the EMA, the EU Medicines Agency, also approved the baby-size vaccine: from 6 months of age to 4 years for “Comirnaty” (the Biontech vaccine– Pfizer) and from 6 months to 5 years for “Spikevax” (Moderna’s vaccine). The data evaluated by the EMA say that the protection especially against severe forms and Covid hospitalizations is comparable to that of adults and therefore with an efficacy greater than 90% and with levels of safety even higher than those already detected for adults and adolescents.

In days the green light in Italy: who will be recommended

It will now be up to the Italian Medicines Agency to authorize it in our country, an ok that of Aifa which could arrive in the next few days and which should arrive together with a circular from the Ministry of Health with an indication to recommend it for fragile children or for the youngest who live with family members suffering from serious pathologies (tumors, cardiovascular or pulmonary diseases) or who are immunosuppressed. All these conditions that in case of contagion expose you to the danger of ending up in hospital, or worse. The baby-size vaccine is the “old” one, that is the monovalent studied on the original Wuhan strain. Ema has also authorized new adapted vaccine Spikevax (Moderna) against the sub-variants Omicron BA.4 and BA.5 for use in already vaccinated persons aged 12 years and older. In recent weeks, the Pfizer Biontech adapted vaccine against the same sub-variants had already been authorized.

Experts: “Useful for protecting fragile children”

“It’s about seeing how to use it. What is important is that it is available – highlights

Silvio Garattini
president of the Mario Negri Irccs Institute of Pharmacological Research -, if we have children with high risk factors, it may be reasonable to do so. No longer a mass campaign, therefore, and I don’t think there will be. But a use aimed at the most fragile “,” From my point of view, it is worth reiterating that this is a vaccine that I would reserve especially for children who belong to the categories at risk “, he adds Gian Vincenzo Zuccotti, dean of the Faculty of Medicine of the State University of Milan and director of Pediatrics and Pediatric Emergency Room of the Asst Fatebenefratelli Sacco-hospital for children Vittore Buzzi. “I would worry – explains Zuccotti – to propose the anti-Covid vaccine to children who belong to the categories at risk, not to all children in these age groups. These vaccines, in fact, have proved to be important and effective for certain categories because they have reduced the possibility of developing severe and severe forms that then led to hospital or admission to intensive care. Fortunately, this type of outcome is not recorded in children except sporadically and mainly in children with risk factors. So I go back to saying that it makes sense that it should be reserved for them ».

Bassetti: “Vaccine for under 5 is of little use, he is already old”

“I believe that this vaccine, right but at the wrong time, is of little use, at this moment we have to dedicate ourselves to the elderly and frail with the updated ones. The approval of the EMA therefore comes at a time when it is really of little use and I do not think that vaccination should be recommended for children with this vaccine. It was fine in 2021, today it seems old to me ». Like this Matteo Bassetti, director of the Infectious Diseases Clinic of the San Martino Polyclinic in Genoa, after the green light of the European Medicines Agency for baby-size vaccines. “I have always supported vaccination for children but – concludes Bassetti – in a moment like this, with the virus causing less demanding forms of the disease, I wouldn’t feel like recommending immunization to all children under 5. If it were an up-to-date vaccine, it could be useful ».