In a statement, the EMA reports that its human medicines committee “recommended granting an indication extension for the Spikevax Covid-19 [brand name for Moderna's vaccine] vaccine to include use in children aged 12 to 17 years".
This vaccine has been authorised for adults by the EU regulator since January of this year and now becomes the second anticovid-19 vaccine approved by the EMA for children aged 12 to 17, after the agency gave similar approval to the drug from Pfizer/ BioNTech.
“The use of Spikevax vaccine in children 12 to 17 years of age will be the same as in people 18 years of age and older. It is given as two injections into the muscles of the upper arm, four weeks apart,” explains the EMA.
The European regulator further indicates that “the effects of Spikevax were investigated in a study involving 3,732 children aged 12 to 17 years”, which revealed that this vaccine “produced an antibody response comparable […] to that seen in young adults aged 18 to 25 years".
And with regard to the most common side effects in children aged 12 to 17 years, they are "similar to those aged 18 and over", covering "pain and swelling at the injection site, tiredness, headache, muscle and joint pain , enlarged lymph nodes, chills, nausea, vomiting and fever”, states the EMA.
According to the European regulator, "these effects are generally mild or moderate and improve within a few days after vaccination."
The EMA Human Medicines Committee admits however that, due to the “limited number of children and adolescents included in the study”, it was not possible to detect “unusual new side effects or estimate the risk of known side effects such as myocarditis (inflammation of the muscle heart) and pericarditis (inflammation of the membrane around the heart)”.
Even so, "the general safety profile of Spikevax determined in adults was confirmed in the study with adolescents", guarantees the EMA, adding that, for this reason, it was concluded that the administration of this vaccine to children aged 12 to 17 years "outweigh the risks, particularly in those with conditions that increase the risk of severe covid-19."
Currently, four anticovid-19 vaccines are approved by the EU regulator: Comirnaty (brand name for the Pfizer/BioNTech vaccine), Moderna, Vaxzevria (new name for the drug by AstraZeneca) and Janssen (Johnson & Johnson group).