The European Medicines Agency (EMA) recommended this Thursday to authorize the booster dose with the Pfizer vaccine in young people between 12 and 17 years old and supported the use of Moderna in children between 6 and 11 years old, with a lower dose than recommended in adults and an interval of four weeks.
Estepa Sports Center (Seville) with a mass vaccination point. EFE/Raul Caro
After analyzing interim data from a clinical trial in people over 16 years of age and real-world evidence of Pfizer booster use in young people in Israel, the EMA believes that “the available evidence is sufficient to conclude that the immune response to a booster dose in adolescents it would be at least equal to that of adults.
It assures that “no new safety problems were identified from the available data”, although it stresses that more information from studies and analyzes in adolescents is expected in the coming months.
However, the agency does not indicate a specific time interval between the second and third doses of Pfizer in adolescents and stresses that “the decision about whether and when to offer boosters in this age group” will have to take into account certain factors.
“Such as the spread and likely severity of the disease (especially with the omicron variant) 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.
Therefore, the EMA recommends “the authorization” of the booster dose in this age group, in a decision aimed at “supporting national campaigns in those Member States that offer booster vaccines to adolescents”, but this does not imply that EMA encourage or urge all youth ages 12-17 to inject a Pfizer booster.
Modern for children from 6 to 11 years old
On the other hand, the agency 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 with the highest dose in 18-25 year olds.
“The 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 the risk of developing Severe COVID-19,” he explained.
The most common side effects observed have been similar to those in those over 12 years of age, including pain and swelling at the injection site, tiredness, headache, chills, nausea, vomiting, fever, and muscle pain, among others, which They improve within a few days of the injection.
Moderna’s vaccine is the second supported by the EMA in children under 11 years of age, since the agency already approved last November the use of Pfizer (Comirnaty) in children between 5 and 11 years of age, also with a lower dose than that used in those older than 12 and with an interval of three weeks between the first and the second.
