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Moderna seeks EU, Canada approval for COVID-19 vaccine’s use in teens

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Cambridge, MASSACHUSETTS: Drugmaker Moderna said on Monday (Jun 7) it has submitted applications to the European and Canadian health regulators seeking authorisation for the expanded use of its COVID-19 vaccine in adolescents.

The company said it plans to file for an emergency use authorisation with the US Food and Drug Administration and other regulatory agencies around the world for the vaccine’s use in adolescents aged 12 to 17.

Moderna’s vaccine is already being used in the United States, the European Union and Canada for people over 18 years of age and vaccinating children has been considered important for reaching herd immunity against the coronavirus.

READ: ‘Prudent’ to extend COVID-19 protection to children now, experts say

Children with COVID-19 mostly develop only mild symptoms or no symptoms, but remain at risk of becoming seriously ill, and can spread the virus.

Vaccinating children has been thought to be crucial to help countries fully reopen schools and return to some semblance of normalcy.

The EU last month cleared Pfizer and German partner BioNTech’s COVID-19 vaccine for use in children as young as 12.

Moderna’s two-shot vaccine last month was shown to be effective in adolescents aged 12 to 17 and showed no new or major safety problems in a clinical trial that evaluated the vaccine in 3,732 teenagers.

The company also said on Monday it has partnered with Israeli company Medison Pharma to commercialise Moderna’s COVID-19 vaccine in 20 markets across Central Eastern Europe and Israel.

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