I’The European Medicines Agency (EMA) on Thursday approved the use of the Moderna vaccine for children aged 6 and over, while serum was previously authorized from the age of 12 in the 27 countries of the European Union. “The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting an extension of indication for the anti-Covid-19 vaccine Spikevax (Moderna) in order to extend its use to children aged 6 to 11 years” , the EMA said in a statement.
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 in children aged 6 to 11 years is similar to that seen in adults,” the EMA said in a statement. The dose of Spikevax serum (developed by Moderna) 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,” the regulator added. Side effects are usually “mild to 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,” said the European regulator in a separate press release.
A booster dose only under conditions
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 likely spread and severity of the disease (especially with the Omicron variant) among younger people. The known risk of side effects, “including the very rare but serious complication of myocarditis”, and the existence of other protective measures and restrictions should also be taken into account, the EMA noted.
“The committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that of adults,” she added. No new safety issues have been identified from the available data, the Amsterdam-headquartered agency said. The EMA’s opinions will now be forwarded to the European Commission, which will issue a decision shortly.