EU regulator endorses use of Moderna Covid-19 vaccine in teens
THE HAGUE (REUTERS) – Europe’s medicines regulator on Friday (July 23) recommended approving the use of Moderna’s Covid-19 vaccine in 12 to 17 year olds, paving the way for it to become the second shot okayed for adolescent use in the European Union.
The use of the vaccine, branded Spikevax, will be the same in children from 12 to 17 years as in people aged 18 and above, the European Medicines Agency (EMA) said, adding the vaccine produced a comparable antibody response to that seen in 18 to 25 year olds.
Vaccinating children has been considered important for reaching herd immunity against the coronavirus and in the light of the highly contagious Delta variant.
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Moderna in May said its vaccine was found to be safe and effective in teens.
The EMA said the two-dose vaccine is given four weeks apart, and its human medicines committee’s recommendation was based on a study of 3,732 participants.
Most children with Covid-19 develop only mild symptoms or none. Yet children remain at risk of becoming seriously ill and can spread the virus. Pfizer and German partner BioNTech’s vaccine was approved for teen use in May.
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EMA’s safety committee said while common side effects in teenagers after vaccination with Spikevax were similar to those seen in older population, due to a smaller study size, the trial could not detect new uncommon side effects or estimate the risk of known ones such as myocarditis and pericarditis.
“The overall safety profile of Spikevax determined in adults was confirmed in the adolescent study; the CHMP (Committee for Medicinal Products for Human Use) therefore considered that the benefits of Spikevax in children aged 12 to 17 outweigh the risks,” the EMA said.
Heart inflammation such as myocarditis and pericarditis have been listed by the EMA as a possible, but rare side effect from use of mRNA vaccines such as Moderna’s and Pfizer’s in adults.
Spikevax is already being used in the European Union for people over 18, and in the United States and Canada. The company has also sought authorisation in the United States and Canada for use in adolescents.
Moderna said on Friday it had submitted data to authorities around the world and expects authorisations for adolescents in the coming weeks.
Formal approval from the European Commission would be needed to start rolling out the vaccine for teenagers in Europe. The executive body typically follows EMA recommendations.
