The European Medicines Agency (EMA) gave the green light on Thursday 24 February to an extension of the use of Spikevax, the Covid-19 vaccine developed by the company Moderna, to children aged 6 to 11 years.
Spikevax already has a conditional marketing authorisation for use in people aged 12 and over.
In this case, the EMA recommends intramuscular administration in the arm at four week intervals. The vaccine dose is 50 µg and provides an immune response in 6 to 11-year-olds comparable to the 100 µg dose for 12 years and older.
The most common vaccine-related side effects for this age group are usually mild and temporary. The Agency believes that the benefit of the vaccine outweighs the risks, particularly for children most at risk of developing a severe form of Covid-19.
The vaccine is as safe for 6 to 11-year-olds as it is for those aged 12 and over.
Further studies will be conducted on the use of this vaccine in this age group. The vaccine will, like all authorised medicines in the EU, be monitored by the European pharmacovigilance system.
It is the second paediatric Covid-19 vaccine recommended in the EU, following the vaccine developed by Pfizer and BioNTech, Comirnaty, which is recommended and licenced for children aged 5 to 11 years.
In addition, on the same day, the EMA’s Committee for Medicinal Products for Human Use recommended the authorisation of a booster dose for the Covid-19 vaccine developed by Pfizer and BioNTech for adolescents aged 12 and over.
The Comirnaty mRNA vaccine had already been recommended by the EMA and authorised in the EU by the European Commission as part of a two-dose primary vaccination schedule in adults, adolescents aged 12-15 years and children aged 5-11 years. A booster dose of the vaccine had already been authorised for people aged 18 and over.
The EMA notes that vaccination remains the prerogative of the Member States and that it will be up to the experts who guide vaccination at domestic level to decide on the plans for vaccination campaigns in their respective countries. According to the Agency, national experts will take into consideration the severity of the epidemic in their country and the extremely small risk of myocarditis.
The European Commission should quickly follow these two recommendations by issuing conditional marketing authorisations. (Original version in French by Émilie Vanderhulst)