European regulator approves use of Moderna vaccine for ages 6 and up

Towards an evolution of vaccination policy for European children. The European Medicines Agency (EMA) approved, on Thursday February 24, the use of Moderna’s anti-Covid vaccine for children aged 6 and over. It was until now only authorized from the age of 12 in the 27 countries of the European Union. The EMA has also given the green light to the booster dose of Pfizer-BioNTech’s Covid vaccine, called Comirnaty, for children aged 12 and over.

“Evidence indicates that the efficacy and safety of Spikevax [le vaccin de Moderna] in children aged 6 to 11 years are similar to those observed in adults”, underlines the EMA in a press release. The dose given to children aged 6 to 11 years will be lower than that given to individuals over 12 years of age.

“The benefits of Spikevax in this age group outweigh the risks, particularly in people with conditions that increase the risk of developing a severe form of Covid-19”, added the regulator. Side effects are usually “mild or moderate” and improve a few days after vaccination.

“The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that a booster dose of the Covid-19 Comirnaty vaccine may be given, where appropriate, to adolescents from 12 years of age”the European regulator said in a separate statement.

However, the EMA stressed that the decision whether or not to offer a booster dose of serum to those aged 12 and over will have to take into account factors such as the “spread and likely severity of disease (especially with the Omicron variant) in younger people”. The known risk of side effects, “including the very rare but serious complication of myocarditis”and the existence of other safeguards and restrictions should also be considered, the EMA noted.

The EMA’s opinions will now be forwarded to the European Commission, which will issue a final decision shortly.