The European Union’s medicines regulator has recommended authorising Moderna’s COVID-19 vaccine for use in children aged between 12 and 17, marking the first time the shot has been approved for people under 18.
In a decision on Friday, the European Medicines Agency (EMA) said research in more than 3,700 children of 12 to 17 years of age showed that the shot produced a comparable antibody response to that seen in 18- to 25-year-olds.
Keep readinglist of 4 items
Use of the vaccine, Spikevax, will be the same in adolescents as in people over 18, the EMA said.
Formal approval by the European Commission – the EU’s executive arm – is needed to start rolling out the vaccine for teenagers. The body typically follows EMA recommendations.
Until now, the vaccine made by Pfizer and its German partner BioNTech has been the only option for use in children as young as 12 in North America and the EU.
Vaccinating children has been considered important for reaching herd immunity and in light of the rapid spread of the highly contagious Delta variant.
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.
‘Benefits outweigh the risks’
Moderna said in May that its vaccine was found to be safe and effective in teenagers. Hundreds of millions of doses of the shot have already have been administered to adults.
The EMA said common side effects in teenagers after vaccination with Spikevax were similar to those seen in older people.
But 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 has 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 EU for people over 18, and in the United States and Canada.
Moderna has also sought authorisation in the US and Canada for its use in adolescents.
But with global vaccine supplies still tight, much of the world still is struggling to immunise adults, let alone children.
Agencies including the World Health Organization have urged rich countries to donate their doses to the developing world – where fewer than 2 percent of people have been vaccinated – rather than moving on to inoculate their less vulnerable populations.