Moderna Asks For EU Permission So That It Can Immediately Be Injected For Young Children

JAKARTA - Moderna Inc has applied for permission to the European Union (EU) for the use of the COVID-19 vaccine in children aged 6-11 years.

Moderna's submission to the EU was made several weeks after delaying a similar submission with US regulators, Tuesday, November 9 yesterday, as quoted by Antara.

The European Union in July authorized Moderna's COVID vaccine for use in adolescents aged 12 to 17.

However, some countries including Sweden are discontinuing its use for people 30 years of age or younger because of rare heart-related side effects.

In late October, Moderna said that US drug regulators needed more time to complete a review of the use of Moderna's vaccine in the 12-17 age group.

That's because US regulators need to study the risk of a type of heart inflammation called myocarditis following vaccine use.

Moderna is delaying applications for permits to use the vaccine in the US for children aged 6 to 11 years, while the US Food and Drug Administration (FDA) is still finalizing its review of the use of the vaccine in the 12 to 17 year age group.

Earlier in October, Moderna said its vaccine produced a strong immune response in children aged 6 to 11 and planned to submit the data to global regulators soon.

Moderna said Tuesday that it had applied to the European Medicines Agency for a 50-microgram dose of the vaccine in children, which is half the dose of vaccine used in adults.