Coronavirus vaccine stock images of Pharmaceutical Moderna.
After delaying the submission of similar applications to US regulators for several weeks, Moderna applied for European approval of its Covid-19 vaccine for children 6-11 years old on Tuesday.
The European Union authorized the vaccine in July for adolescents between the ages of 12 and 17, but due to rare heart-related side effects, several countries, including Sweden, suspended the vaccine for people aged 30 and under.
Moderna said in late October that the US drug regulator needs more time to complete its review of its use in the 12-17 age group because it is studying the risk of a type of cardiac inflammation called myocarditis after vaccination.
The drugmaker postponed the U.S. application for children aged 6 to 11, and the FDA completed a review of the vaccine’s use in the 12 to 17 age group.
In early October, the company stated that its vaccine had produced a strong immune response to children between the ages of 6 and 11, and plans to submit the data to global regulators soon.
Moderna said on Tuesday that it has applied to the European Medicines Agency for a 50 microgram dose of the vaccine for children, which is half the dose for adults.
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