The European Medicines Agency (EMA) gave the green light, on Friday 28 May for the use of the Covid-19 vaccine developed by Pfizer/BioNTech for young people aged 12 to 15 years.
The Comirnaty vaccine can therefore be given to adolescents as it is currently given to people aged 16 and over, in the form of two injections three weeks apart, says EMA.
The efficacy of Comirnaty was calculated in almost 2,000 young people who were given the vaccine or a placebo. “Of the 1,005 children receiving the vaccine, none developed Covid-19, compared to 16 out of the 978 who received the dummy injection”, the European agency stated, noting that the immune response in adolescents was comparable to that of the 16-25 year old group.
“We don’t think that at this time there is any reason to believe that anything different will happen in this age group than what we see in young adults”, said Dr Marco Cavaleri, head of vaccine strategy at the EMA.
As for the most frequent side effects - pain at the injection site, fatigue, headaches appearing just after the vaccination - the Agency assures us that they occurred in the same way in young people aged 12 to 15 as in people aged 16 and over.
However, the trial did not result in the detection of any rare side effects due to the limited number of children in the study. Nevertheless, EMA considered that the benefits of the vaccine still outweighed the risks for this age group, especially for young people at risk of severe Covid-19. It will continue, however, to monitor the situation closely.
The next vaccine to be reviewed by the European Agency for use in younger children could be Moderna, according to EMA experts. (Original version in French by Agathe Cherki)