The American company Moderna announced on Tuesday that it has submitted to the European Medicines Agency the official application for the authorization of its anti-COVID-19 vaccine for children in the age group 6-11 years.
The EMA approved the Moderna vaccine in July for adolescents between the ages of 12 and 17. In late October, Moderna announced that the US Food and Drug Administration (FDA) needed more time to complete the analysis of medical data associated with the administration of this serum to the 12-17 age group, as it is studying the risk of the appearance of a type of heart inflammation, called myocarditis, after vaccination, reports Reuters, quoted by Agerpres. However, the cases were extremely rare.
As a result, Moderna has postponed its application for vaccination of children aged 6-11 in the United States until the FDA completes its analysis of the use of this vaccine for the 12-17 age group.
In early October, the US company announced that its vaccine was generating a strong immune response in children aged 6-11 and that it intended to transmit medical data to all regulatory agencies around the world soon.
On Tuesday, Moderna representatives said that the application submitted to the EMA aims at administering a dose of 50 micrograms of vaccine to children in the age group 6-11 years, which represents half of the concentration of doses administered in adults.
Editor : M.B.