Moderna’s COVID vaccine approved for children aged 12-17 by EU

The European Union medicine regulator on Friday approved the COVID-19 vaccine developed by American biotech firm Moderna for use in children aged between 12 and 17, making it the second vaccine cleared for use in adolescents in the continent. 

“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,” The European Medicines Agency (EMA) said in a statement. 

The vaccine will be administered in two doses, which will be four weeks apart from each other. The vaccine’s effects were studied in 3,732 children aged between 12 and 17, the EMA said. 

“This ongoing study is being carried out in accordance with Spikevax’s paediatric investigation plan (PIP), which was agreed by EMA’s Paediatric Committee (PDCO),” the medicines watchdog said in its statement. 

“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,” it added. 

The vaccine uses genetic material to deliver instructions to cells and create the spike protein of the coronavirus, thus inducing an immune response without expoing the body to the actual infection. 

“In addition, none of 2,163 children receiving the vaccine developed COVID-19 compared with four of 1,073 children given a dummy injection. These results allowed the CHMP to conclude that the efficacy of Spikevax in 12- to 17-year-olds is similar to that in adults.”

It said that the side effects of the vaccine in youngsters are simiar to that seen in people aged 18 and above. The side effects include pain and swelling at the injection site, tiredness, headache, muscle and joint pain, enlarged lymph nodes, chills, nausea, vomiting and fever. 

It said the side effects are mild and moderate and ease off within a few days of vaccination. 

This comes after the Amsterdam-based agency approved the vaccine developed by Pfizer-BioNTech for use in adolescents. 

The EU had on Thursday confirmed over 200 million adults had been fully vaccinated, over half its adult population, but still short of its 70% target for the summer.