The European Medicines Agency (EMA) approves the use of Moderna’s anti-Covid vaccine for children aged 6 and over, serum which was previously authorized from the age of 12 in the 27 countries of the Union European. 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 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 vaccine Comirnaty may be given, where appropriate, to adolescents from 12 years of age,” said the European regulator in a separate press release.
The EMA however 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 “probable spread and severity of the disease (especially with the Omicron variant) in younger people.