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Tuesday, December 7, 2021

Moderna requests EU to approve its vaccine for adolescents

Pharmaceutical company Moderna has requested that the EU approves its vaccine for use in adolescents.

Moderna confirmed that it filed for conditional marketing approval of its vaccine for teenagers in the European Union today after submitting a request for approval to the European Medicines Agency (EMA).

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The pharmaceutical company has also applied to the health regulators in Canada and has plans to apply in the US and other countries.

Currently, the vaccine can only be used for people over the age of 18 but this could change if the EMA approves Moderna’s request.

The results of a clinical trial, which had 2,500 teenage participants, found that no Covid-19 cases were reported.

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The teenage participants received both doses of the vaccine during the clinical trial.

Following the trial, Moderna stated that the vaccine was well tolerated and was generally consistent with the Phase 3 COVE study in adults. With no significant safety concerns identified, the majority of the side effects were mild or moderate, which included headaches, fatigue, weakness, muscle pain and chills.

The participants will be monitored over a 12-month basis after their second dose to examine the long-term protection and safety of the vaccine.

Currently, there are no Covid-19 vaccines being administered to children in Ireland, however, the Pfizer/BioNTech vaccine was approved for use in children aged 12-15 last month.

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