It is to no longer know what to think.
While the French High Authority of Health has been recommending since Monday to do without the Moderna vaccine in young people, the AEM has started to assess a request for an extension of the use of Spikevax for children aged 6 to 11 years.
The American pharmaceutical group is part of a very well-honed administrative procedure, followed by all the other candidate vaccines: "the EMA's Committee for Medicinal Products for Human Use (CHMP) will examine the data relating to the vaccine, including results of an ongoing clinical study involving children aged 6 to 11 years, in order to decide whether to recommend the extension of its use ”, announces the agency in a press release.
As part of the emergency procedure, the effects of the messenger RNA vaccine and its benefits compared to its risks will be examined within two months, after which the drug agency will issue an opinion, unless details or data additional are requested from Moderna.
Spikevax was first authorized in the European Union in January 2021 for adults.
It was validated in July for adolescents aged 12 to 17.
Pfizer / BioNTech vaccine also under study
Monday, after the Epi-Phare study involving patients from 12 to 50 years old hospitalized in France for myocarditis or pericarditis, which confirmed that Pfizer vaccines and especially Moderna increased the risk of occurrence of these inflammations of the heart in seven days after vaccination, and more often in men under 30, the High Authority for Health has recommended the use of the Pfizer vaccine for those under 30.
Conversely, she recommended that Spikevax "whose vaccine efficacy seems slightly better, can be used as a primary vaccination and for the administration of a booster dose in half-dose in subjects over the age of 30. years ".
Germany made the same decision on Wednesday.
Read also Pfizer and Moderna vaccines: what the French study says that confirms the risk of myocarditis and pericarditis
Since October 18, the European Medicines Agency has been evaluating Pfizer / BioNTech's vaccine in children aged 5 to 11 with a view to possible authorization.
