The European Medicines Agency (EMA) on Thursday approved the use of Moderna's anti-Covid vaccine for children aged 6 and over, a serum which was previously authorized from the age of 12 in the 27 countries of the 'European Union.
Read alsoModerna's anti-Covid vaccine fully authorized in the United States
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.
Mild side effects
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.
However, the EMA stressed that the decision whether or not to offer a booster dose of the 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 must 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 final decision shortly.
