Covid-19: European regulator approves Moderna vaccine for 12-17 year olds

Published on : 07/23/2021 – 4:43 PM

The European Medicines Agency (EMA) approved, Friday July 23, the use of the anti-Covid Moderna vaccine for 12-17 year olds, which becomes the second vaccine to be authorized for adolescents in the 27 countries of the ‘European Union.

The administration of the Spikevax (Moderna) vaccine for 12-17 year olds will be the same as for people 18 years and older, two injections into the muscles of the upper arm, four weeks apart.

“The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended to grant an indication extension for the Covid-19 Spikevax (Moderna) vaccine to extend its use to children aged 12 to 17,” said the European regulator in a press release.

Protection of adolescents deemed effective

The effects of Spikevax, from the American biotech company Moderna, were studied in a study involving 3,732 children aged 12 to 17 years.

This study showed that the serum produced an antibody response comparable in 12 to 17 year olds to that seen in young adults aged 18 to 25.

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“These results allowed the CHMP to conclude that the effectiveness of Spikevax in 12 to 17 year olds is similar to that of adults,” concluded the agency, headquartered in Amsterdam.

The Pfizer / BioNTech alliance vaccine, using the same mRNA technology as the Moderna vaccine, had already been authorized as early as 12 years old in the United States, Canada and the 27 countries of the European Union.

Adolescents generally develop less severe forms of Covid-19 than older people, but they are not immune to infection and participate in the transmission of the virus within the population. This is why their immunization is necessary in order to help stop the epidemic, according to experts.

Uncertainties around serious side effects

The European Medicines Agency clarified that it had found the same type of mild side effects with the Moderna vaccine in adolescents as in adults, but was unable to detect more rare or risky side effects due to the narrowness of the observed sample.

“The overall safety profile of Spikevax determined in adults was confirmed in the study in adolescents. The committee therefore considers that the benefits of Spikevax in children aged 12 to 17 years outweigh the risks”, EMA said in a statement.

The Spikevax vaccine is already administered to people over 18 years of age in the European Union. Enlargement to 12-17 year olds must now be formally validated by the European Commission.

Half of adults in Europe, or 200 million people, are vaccinated against Covid-19, the European Commission said on Thursday. The vaccination of adolescents is considered an important step in achieving collective immunity against the new coronavirus and its mutations, including the Delta variant, which is particularly contagious, which is now causing a strong rebound in contaminations in many countries.

With AFP and Reuters