European Medicines Agency Approves Moderna’s COVID Vaccine for Children Ages 12-17
A doctor preparing the Moderna COVID-19 vaccine at the Naval Hospital in Bremerton, Washington, US.

Moderna’s COVID-19 vaccine was approved for use in children 12 to 17 years of age by the European Medicines Agency (EMA), making it the second vaccine recommended for use in children in Europe, following the EMA’s approval of Pfizer’s Comirnaty child vaccine formulation in May.

The effects of Moderna’s vaccine in adolescents was evaluated in a study with 3,732 participants. The study demonstrated that the vaccine produced a similar antibody response in those aged 12-17, as compared to young adults 18-25, for whom the vaccine was already approved.

None of the 2,163 children receiving the vaccine became infected with SARS-CoV2, while four of the 1,073 children that were given a placebo injection developed COVID-19.

The side effects in children were similar to those in people over the age of 18, including pain and swelling at the injection site, fatigue, headache, muscle and joint pain, chills, nausea, and fever.

The safety of the Moderna vaccine, as seen in adults, was confirmed in the adolescent study, the EMA stated. .

Although the EMA’s vaccine advisory committee noted that the study was too small to detect new uncommon side effects, the EMA concluded that the benefits of the vaccine outweigh the risks.

Pfizer’s COVID-19 vaccine was similarly evaluated in a study of 2,260 children aged 12 to 15 years. Of the 1,005 children that received the vaccine, none developed a COVID infection, compared to 16 children out of the 978 who received a placebo jab.

The most common side effects in children were pain at the injection site, tiredness, headache, muscle and joint pain, chills, and fever. The side effects were usually mild or moderate and improved within a few day of the vaccination.

The EMA said that it will continue to monitor the safety and efficacy of both vaccines in children as it is used across the region in vaccination campaigns.

Image Credits: Flickr – Official US Navy.

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