January 20, 2022

Aifa gives the green light to the Covid vaccine for children aged 5 to 11


Vaccination will take place with two doses of Pfizer’s vaccine, at one third the dosage for adults, three weeks apart.

Aifa gave the green light to vaccination for children in the 5-11 age group. On November 25, the approval of Ema, the European Medicines Agency, had already arrived for the administration of the drug.

Available data demonstrate a high level of effectiveness and there are currently no warning signs in terms of safety, said the Technical Scientific Commission of the Italian Medicines Agency, which approved the extension of theuse of the Cominarty vaccine (Pfizer) for children aged 5 to 11.

Vaccination will take place with two doses of Pfizer’s vaccine, one-third the dosage for adults, three weeks apart.

The Cts Aifa also recommended, for the vaccine for children, the exclusive use of the ad hoc pediatric formulation, suggesting when possible the adoption of vaccination courses suitable for age, thus separating them from those intended for adolescents and adults.

The Commission said that although Sars-CoV-2 infection is certainly more benign in children, in some cases it can be associated with serious consequences, such as the risk of developing multisystem inflammatory syndrome (MIS-c), which can also require admission to intensive care. And points out that vaccination entails benefits such as the possibility of attending school and leading a social life characterized by recreational and educational elements that are particularly important for psychic and personality development in this age group.

The Cts Aifa also announced that the Pfizer anti-Covid vaccine study on children has shown efficacy in reduction of symptomatic infections from Sars-CoV-2 equal to 90.7% compared to placebo and the non-inferiority of the immunological response compared to that observed in the population 16-25 years old.

On the security frontthe study did not reveal any related serious adverse events to the vaccine and in particular, in the 3,100 vaccinated children, no cases of anaphylaxis or myocarditis / pericarditis were observed, at least in the short-term follow-up currently available. In addition, pharmacovigilance data relating to approximately 3,300,000 children aged 5-11 already vaccinated – for the most part with one dose – in the United States, do not currently highlight any warning signs in terms of safety.

The data available in the ISS reports, Aifa recalls, show a clear increase in the number of infections in the 5-11 year old population in recent weeks. In addition to the direct benefits, concludes the Cts Aifa in the opinion in favor of administration, vaccination of children would lead to an increase in the vaccination coverage of the entire population and, therefore, greater protection even for the most fragile subjects of all ages, especially if cohabiting. with the children.

December 1, 2021 (change December 1, 2021 | 21:29)

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