EU regulator approves Moderna's Covid-19 vaccine for children aged 12 to 17
- The European Medicines Agency said Moderna's Covid vaccine was found safe for children aged 12 to 17 years and produced a comparable antibody response as seen in young adults aged 18 to 25 years.
The European Medicines Agency (EMA) on Friday approved Moderna’s Covid-19 vaccine for children aged 12 to 17 years. The EU drug regulator said that the effects of the Spikevax vaccine were investigated in a study involving 3,732 children aged 12 to 17 years, which produced a comparable antibody response as seen in young adults aged 18 to 25 years.
None of 2,163 children administered with the Spikevax vaccine got infected with Covid-19 compared with four of 1,073 children administered placebo. The EMA said that the results allowed the Committee for Medicinal Products for Human Use (CHMP) to conclude that the efficacy of Moderna’s Covid-19 vaccine in 12- to 17-year-olds is similar to that in adults.
The most common side effects of the Spikevax vaccine in children were similar to those in adults, including pain and swelling at the injection site, headache, nausea, vomiting and fever. The EMA said in a statement that these side effects were usually mild to moderate and improved within a few days from the vaccination.
Due to the limited number of participants, the trial could not have detected rare side effects or estimated the risk of known side effects such as inflammation of the heart muscle, the EMA added. The agency stressed that the overall safety profile determined in adults, however, was confirmed in the adolescent study, suggesting that the benefits of Spikevax in adolescents outweigh the risks.
The vaccine will be administered as two injections in the muscles of the upper arm, four weeks apart.
The approval for vaccine use in children comes at a time when low- and lower-middle-income countries are struggling to vaccinate even their frontline workers and high-risk groups. The World Health Organization (WHO) has repeatedly urged the world to donate Covid-19 vaccines to poorer nations instead of vaccinating their children.