The European Medicines Agency (EMA) is currently examining the application for authorization of Moderna’s coronavirus vaccine for children aged 6 to 11, the European regulator said on Wednesday, adding that it would return its response to here about two months.
Several countries, including France and Germany, advise against the use of Moderna vaccine in people under 30 years of age because of a low risk of heart inflammation.
Risks of myocarditis
The American biotechnology company filed on Tuesday an authorization request for its vaccine against Covid-19 for children aged 6 to 11 with the European regulator. “The current assessment schedule provides for an opinion in about two months, unless additional information or analysis is needed,” the Amsterdam-based European Medicines Agency (EMA) said in a statement.
“This is an accelerated timeline compared to similar types of reviews outside of a pandemic,” the EMA added. Moderna’s vaccine is currently authorized from the age of 12 by the EMA. But several countries, including France on Monday, advised against using Moderna below a certain age (30 years in France), because of concerns about the risk of myocarditis. This side effect has been detected especially in adolescents and young adults, especially males.
“Robust” antibodies detected
At the end of October, Moderna announced positive results from its clinical trials for children aged 6 to 11, the vaccine having elicited “a strong immune response” with “robust” antibody levels detected. Pfizer’s serum has only recently been authorized for this age group in the United States, where Moderna’s remedy is currently only authorized from the age of 18.
Moderna stressed that its application for authorization for young children in the EU was its “first application for authorization for the use of its vaccine for this age group”. The EMA is also studying data from Pfizer, which has applied for authorization for its own vaccine in 5 to 11 year olds. The review could be concluded in December, she said last week.