European drug regulator approves Moderna COVID-19 vaccine, Spikevax, for 12-17-year-olds
The European drug regulator on Friday recommended approving Moderna's coronavirus vaccine, called Spikevax, for use in children aged 12-17 years, making it the second vaccine to be authorized for this age group in the region. The European Medicines Agency (EMA) said a study involving over 3,700 children aged 12-17 years showed Spikevax triggered immune responses similar to those in young adults. Here's more.
Talking about the study, the Amsterdam-based European drug regulator stated, "The use of the Spikevax vaccine in children from 12 to 17 years of age will be the same as in people aged 18 and above." Notably, the decision to recommend authorization of the Moderna vaccine comes nearly two months after the Pfizer-BioNTech vaccine was approved for adolescents by the EMA in May.
The EMA said Spikevax's effects were studied among a total of 3,732 children aged 12-17 years. It said the Moderna vaccine produced an antibody response similar to what was seen in young adults aged 18-25 years. "The study showed that Spikevax produced a comparable antibody response in 12- to 17-year-olds to that seen in young adults aged 18 to 25 years," the EMA said.
The study also showed none of the participants who were administered Spikevax was infected with COVID-19; four cases were seen in the group that received dummy shots. The most common side effects observed—including pain/swelling at the injection site, fatigue, headache, nausea, vomiting, and fever—were similar to those seen in adults. The Moderna vaccine is required to be given in two doses, four weeks apart.
As the EMA recommended authorizing Spikevax for those aged 12-17 years, it now needs to receive formal approval by the European Commission to be administered to this age group in the European Union (EU) region. The EU Thursday said 200 million Europeans have so far been fully vaccinated—more than half the population, which is still short of its 70% target set for the summer.
Notably, this is the first time that the Moderna vaccine has been approved by any drug regulator for use in those aged 12-17 years. Even the US Food and Drug Administration (FDA) is still studying whether its use can be extended to this age group.
However, the American and European regulators have earlier warned the Moderna and Pfizer vaccines appear linked to extremely rare reactions, such as chest pain and heart inflammation, in teens and young adults. Meanwhile, both Moderna and Pfizer have already started testing their vaccines in even younger children—from those aged 11 years to six-month-old infants as well.