The verdict of Ema, the European medicines agency, has arrived. Children aged 5 to 11 can be vaccinated. The EMA has in fact recommended granting an extension of the indication for Pfizer-BioNtech’s Covid vaccine to include use in the pediatric age range 5-11 years. The vaccine is already approved for use in adults and children aged 12 and over, and little ones are already being vaccinated in many countries.
Ema also specified that the dose of Comirnaty – this is the name of the Pfizer-Biontech vaccine – will be lower than that used in people aged 12 years or older (10 µg compared to 30 for adults). As in the older age group, it is given as two intramuscular injections into the upper arm, three weeks apart.
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A main study in children aged 5 to 11 years showed that the immune response to Comirnaty given at a lower dose (10 µg) in this age group was comparable to that seen at the higher dose (30 µg) in patients aged 16 to 25 years. The effectiveness of Comirnaty has been calculated in nearly 2,000 children between the ages of 5 and 11 who had no signs of previous infection.
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These children received the vaccine or a placebo. Of the 1,305 children who received the vaccine, three developed Covid-19 compared with 16 of the 663 children who received the placebo. This means that, in this study, the vaccine was 90.7 percent effective in preventing symptomatic Covid-19, although the real rate could be between 67.7 percent and 98.3 percent.
As for the adverse effects in children 5-11 years old, they are similar to those reported over 12 years: pain at the injection site, fatigue, headache, redness and swelling at the injection site, body aches and chills. Usually mild or moderate effects which disappear a few days after the vaccine. a few days of vaccination.
The EMA committee concludes that the benefits of Comirnaty in children between 5 and 11 years outweigh the risks, particularly in those who have an increased risk of becoming seriously ill with Covid.
The safety and efficacy of the vaccine in adults and children will continue to be closely monitored as is done in EU member states’ vaccination campaigns through pharmacovigilance systems and ongoing studies.
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