Another COVID-19 vaccine has been approved for children! Human medicines committee (CHMP) at European Medicines Agency (EMA) has recommended granting an extension of indication for Spikevax (previously COVID-19 Vaccine Moderna) to include use in children aged 12 to 17 years.
The effects of Spikevax have been investigated in a study (NCT04649151) involving 3732 children aged 12 to 17 years. This study is being carried out in accordance with the paediatric investigation plan (EMEA-002893- PIP01-20), agreed by the Paediatric Committee of EMA.
The study results showed that Spikevax produced an antibody response in 12- to 17-year-olds comparable to that seen in young adults aged 18 to 25 years. In addition, none of 2163 children receiving the vaccine developed COVID-19 compared with 4 of 1073 children given placebo.
The most common side effects in children aged 12 to 17 are similar to those in adults. Moreover, the CHMP claimed that due to the limited number of children and adolescents included in the study, the trial could not have detected new uncommon side effects or estimated the risk of known side effects such as myocarditis and pericarditis.
However, the overall safety profile of Spikevax was confirmed in the adolescent study; the CHMP therefore considered that the benefits of Spikevax in children aged 12 to 17 outweigh the risks, especially in those with conditions that increase the risk of severe COVID-19.
The safety and efficacy of the vaccine in both children and adults will continue to be monitored through the EU pharmacovigilance system and ongoing and additional studies performed by the company and the European authorities.
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