Coronavirus: Moderna seeks EU approval to use its vaccine in children
Moderna wants to get permission to give the vaccine to children between the ages of 6 and 11 in the European Union.
The American pharmaceutical company Moderna submitted the third application for a license in Europe to administer its vaccine against COVID-19 to children aged 6-11 years, according to the APE-MPE.
The European Union approved the vaccine in July for adolescents aged 12 to 17, but several countries, including Sweden, stopped using it for young people aged 30 and younger due to rare heart side effects.
Moderna announced in late October that the U.S. Drug Enforcement Administration needs more time to complete its evaluation for use in the 12-17 age group as it studies the risk of a type of inflammation in the heart called myocarditis after vaccination.
The pharmaceutical industry has delayed applying to the US for the vaccine to be given to children aged 6 to 11, while the US FDA is completing its assessment of vaccine use in the 12-17 age group.
Earlier in October, the company said the vaccine was causing a strong immune response in children aged six to 11 and that it planned to submit the data to regulators around the world soon.
Moderna said it had applied to the European Medicines Agency (EMA) for a dose of 50 micrograms of the vaccine in children, at half the content used to vaccinate adults.
