The European Medicines Agency has approved the Moderna vaccine for children ages 12 and over, making it the second vaccine green-lit for teens in the EU after BioNTech/Pfizer’s jab in May, the regulator announced Friday.
Previously, Moderna was authorized for use in people aged 18 and above. The recommendation Friday came from the EMA’s human medicines committee, which found that the vaccine could be used in the same way as it was in adults. The recommendation will still need to be formally accepted by the European Commission.
The ongoing study that informed the recommendation found that the Moderna jab produced a comparable antibody response in 12- to 17-year-olds as it did in young adults. None of the 2,163 children receiving the vaccine developed COVID-19, whereas four children in the control group contracted the virus. The committee concluded that the efficacy of the vaccine was similar to that seen in adults.
Children experienced similar side effects to adults, such as pain in the site of the injection, tiredness and headache.
The committee found that the benefits of Moderna in children outweighed the risk, “in particular in those with conditions that increase the risk of severe COVID-19.”
The authorization means that countries will need to decide whether to offer Moderna to their teens. While many European countries are offering BioNTech/Pfizer to children who meet the age requirement, experts advising the governments in Germany and the U.K. have recommended the jab only for those with comorbidities.
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