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Moderna requests EU approval of its vaccine for adolescents

A clinical trial found the vaccine was safe and effective in teenagers.
Jun 7th 2021, 2:31 PM 12,704 3

MODERNA HAS APPLIED to the EU for approval for the use of its Covid-19 vaccine in teenagers.

The company filed for conditional marketing approval of its vaccine in adolescents in the European Union, it confirmed today.

It has made a similar request to the health regulator in Canada and intends to also apply in the US and other countries.

If the European Medicines Agency (EMA) approves the request, the vaccine – which is currently approved for people over the age of 18 – could be authorised for use in teenagers.

In a statement, Moderna confirmed that it submitted the request for approval to the EMA.

Moderna CEO Stéphane Bancel said the company is “committed to doing our part to help end the Covid-19 pandemic”.

A clinical trial of the vaccine in teenagers found no cases of Covid-19 in 2,500 participants who received two doses.

Moderna said the vaccine was “generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults”.

“No significant safety concerns have been identified to date. The majority of adverse events were mild or moderate in severity,” it said.

The most common adverse effects after the second dose were headache, fatigue, muscle pain or weakness and chills.

Participants are being monitored for 12 months after their second dose to assess its long-term protection and safety.

“We are encouraged that the Moderna Covid-19 vaccine was highly effective at preventing Covid-19 and SARS-CoV-2 infection in adolescents,” Bancel said.

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Conditional marketing authorisation of Moderna’s vaccine was recommended by the EMA for people aged 18 and over in January, which was granted by the European Commission.

Last month, the EMA approved the use of the Pfizer/BioNTech Covid-19 vaccine for children aged 12-15.

No Covid-19 vaccines are currently being administered to children in Ireland.

As of 11 May – the last update on the Covid-19 hub prior to the ransomware attack on the HSE – 90,956 doses of the Moderna vaccine had been administered in Ireland.

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Lauren Boland

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