The vaccine was so far allowed from 12 years in the twenty-seven countries of the European Union. AEM also gave its downstream at the Pfizer-Biontech Anti-Covid-19 Vaccine Recall Dose, called Comirnaty, for children 12 and over.
Le Monde
The European Medicines Agency (AEM) approved, Thursday, February 24, the use of the VVID-19 Moderna vaccine for children aged 6 and over, while the serum was allowed to leave 12 years in the twenty-seven countries of the European Union. AEM also gave its downstream at the pfizer-biontech Anti-Covid-19 vaccine recall dose, called Comirnaty, for children aged 12 and over.
“The evidence indicates that the efficacy and safety of Spikevax in children aged 6 to 11 are similar to those observed in adults,” EMA underlined in a statement. The dose of the serum of Spikevax (Developed by Moderna) administered to children aged 6 to 11 will be lower than administered to individuals over 12 years old.
Side effects generally “light or moderate “
“The profits of Spikevax in this age group outweigh the risks, especially among people with conditions that increase the risk of developing a severe form of CVIV-19,” added the regulator. Side effects are usually “light or moderate” and improve a few days after vaccination.
The European regulator stated in a separate statement:
“The Human Drug Committee (CHMP) of the AEM recommended that a recall dose of the Vovid-19 Comirnaty vaccine can be administered, as appropriate, to adolescents from 12 years. “
However, the AEM stressed that the decision to offer or not a recall dose of the serum at the age 12 and over will have to take into account factors such as the “propagation and probable severity of the disease (in particular. Omicron Variant) in younger people “.
The known risk of side effects, “in particular the very rare, but serious complication of myocarditis”, and the existence of other measures of protection and restrictions must also be taken into account, noted the AEM.
“The Committee considered that the evidence available were sufficient to conclude that the immune response to a recall dose in adolescents would be at least equal to that of adults,” she added.
No new security issues has been identified from the available data, highlighted the agency, headquartered in Amsterdam. EMA’s opinions will now be forwarded to the European Commission, which will soon make a final decision.