The European Medicines Agency (EMA) recommended this Thursday to authorize the booster dose with the pfizer in young people aged between 12 and 17 and endorsed the use of modern in children aged 6 to 11 years, with a dose lower than that recommended for adults and an interval of four weeks.
After analyzing provisional data from a clinical trial at ages 16 and older and real-world evidence from Pfizer booster use in youth in Israel, the EMA believes that “the available evidence is sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to to that of adults”.
He assures that “no new safety problems were identified from the available data”, although he stresses that more information is expected on studies and analyzes in adolescents in the coming months.
However, the agency does not point to a specific time interval between the second and third dose of Pfizer in adolescents and highlights that “the decision on whether and when to offer boosters in this age group” will have to take into account some factors.
“For example, the likely spread and severity of the disease (especially with the variant omicron) in younger people, the known risk of side effects (particularly the very rare but serious complication of myocarditis) and the existence of other protective measures and restrictions”, he details.
Thus, the EMA recommends “authorizing” the booster dose in this age group, in a decision that aims to “support national campaigns in member states that decide to offer booster vaccines to adolescents”, but this does not imply that the agency urges or incites the injection of a Pfizer booster for all 12 to 17 year olds.
Modern Vaccine in children under 11 years old
On the other hand, the EMA recommended the use of Moderna (Spikevax) in children aged 6 to 11 years after reviewing a study that showed that the immune response – in antibody levels – to the lowest dose of Spikevax (50 µg) was “comparable” to that seen at the highest dose at 18-25 years.
“Evidence indicates that the efficacy and safety of Spikevax in children 6 to 11 years of age are similar to those in adults (…) Its benefits in this age group outweigh the risks, especially in those with conditions that increase their risk of developing covid -19”, he explained.
O secundary effects The most common symptoms observed were similar to those over 12 years of age, such as pain and swelling at the injection site, tiredness, headache, chills, nausea, vomiting, fever, muscle pain, among others, which improve over time. . a few days after the injection.
Moderna’s vaccine is the second EMA-supported vaccine in children under 11 years old, as the agency already approved last November the use of Pfizer (Comirnaty) in children between 5 and 11 years old, also at a lower dose than that used in over 12 years old and with an interval of three weeks between the first and the second.
