Already authorised for the over-18s and then for adolescents (see EUROPE 12729/19), the Covid-19 vaccine Comirnaty, from Pfizer-BioNTech, can now be given to children aged between 5 to 11 in the EU. The European Medicines Agency (EMA) issued an opinion to this effect on Thursday 25 November.
However, it will be up to the EU27 governments and national health authorities to decide whether or not to call the youngest for their vaccinations in their respective countries.
The efficacy of Comirnaty was calculated in nearly 2,000 children aged between 5 to 11 who had no evidence of previous infection, the EMA said in a press release. It added that of the 1,305 children who received the vaccine, three contracted Covid-19, compared to 16 of the 663 who received the placebo.
“In children aged between 5 to 11, the dose of Comirnaty will be lower than that used in people aged 12 years and over (10 µg compared with 30 µg). As in the older age group, it is given as two injections into the upper arm muscle, three weeks apart”, the Agency recommends.
Finally, it indicates that the most common side effects observed for this age group are similar to those observed in the older age groups (e.g. injection site pain, fatigue, headache and muscle pain) and that they improve in the days following vaccination. (Original version in French by Agathe Cherki)