It is the first vaccine against Covid-19 authorized for children in Europe. The European Medicines Agency (EMA) announced Thursday, November 25, that it has approved the use of Pfizer-BioNTech’s messenger RNA vaccine for children aged 5 to 11. At the end of May, she had already authorized its administration to adolescents over 12 years old.
“The benefit of Comirnaty [le nom commercial du vaccin] for children aged 5 to 11 is greater than the risk, especially for those whose condition increases the risk of developing a severe form of Covid-19 ”, explained the European regulator. In order for the Twenty-Seven to be able to launch vaccination campaigns targeting the youngest, the decision of the EAJ must still be validated by the European Commission, which, in general, follows the advice of the authority.
According to the AEM recommendation, children aged 5 to 11 should receive – in two injections three weeks apart – one third of the dose given to adults and adolescents over 12 years old.
A trial carried out on 2000 young people of this age group made it possible to conclude that the vaccine was 90.7% effective. Of the 1,305 children who were immunized, three developed the disease, compared to sixteen of the 663 who received a placebo. The AEM says it has identified undesirable effects “Light or moderate” comparable to those observed in the elderly: pain at the injection site, fatigue, headache or cold.
The wave of Covid-19 that hit Europe particularly affects children, who are not vaccinated. In this context, class closures are increasing. In the Netherlands, where the AEM is headquartered, those under 12 are the group where the virus is progressing the fastest currently, the authorities explained earlier this week.
“We know that severe Covid-19 and death remain quite rare in children, but serious illness can occur at all pediatric ages”, warned Marco Cavaleri, head of the vaccine strategy of the AEM. Especially since “High transmission leads to increased hospitalizations in children of all ages.”
In its last assessment of the situation in Europe, on November 24, the European Center for Disease Prevention and Control (ECDC) devoted part of its analysis to the youngest. “Children represent a growing share of those infected and hospitalizations, in part because older populations are increasingly vaccinated”. If the AEM were to approve a vaccine for 5 to 11 year olds, writes the health agency, “The impact on mortality would be negligible in the short term”. But, in the longer term, she continues, “This could have a greater impact on transmission, which would be followed by a drop in mortality and hospitalizations of other age groups”.
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Vaccination against Covid-19: the European green light accelerates reflections on the vaccination of children