The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty® to include use in children aged 12 to 15.
The effects of Comirnaty® in children were investigated in 2260 children aged 12 to 15 years. This study (NCT04368728) was carried out in accordance with the paediatric investigation plan (PIP), agreed by the Paediatric Committee (PDCO) of the EMA.
The trial showed that the immune response to Comirnaty® in this group was comparable to the immune response in the 16 to 25 age group (as measured by the level of antibodies against SARS-CoV-2).
Of the 1005 children receiving the vaccine, none developed COVID-19 compared to 16 children out of the 978 who received the placebo. Therefore, in this study, the vaccine was 100% effective at preventing COVID-19 (although the true rate could be between 75% and 100%).
The most common side effects in children aged 12 to 15 are similar to those in people aged 16 and above. They are usually mild or moderate and improve within a few days from the vaccination.
The CHMP noted that due to the limited number of children included in the study, the trial could not have detected rare side effects. The committee also noted that the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA is currently assessing very rare cases of myocarditis and pericarditis occurred after vaccination with Comirnaty®, mainly in people under 30 years of age. Currently there is no indication that these cases are due to the vaccine and EMA is closely monitoring this issue.
However, the CHMP considered that benefits of Comirnaty® in children aged 12 to 15 outweigh the risks, particularly in children 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 European pharmacovigilance system and ongoing and additional studies by the company and European authorities.
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