EMA Recommends Pfizer Vaccine for Children Aged 5-11

Dawn O'Shea

November 26, 2021

The European Medicines Agency (EMA)'s human medicine committee (CHMP) has recommended giving the COVID-19 vaccine Comirnaty to children aged 5 to 11 years. Comirnaty, developed by BioNTech and Pfizer, is already approved for use in adults and children aged 12 and older.

In children 5-11 years of age, the dose will be 10 µg, compared to the 30 µg which is given to those aged 12 years and older. As in the older age group, the vaccine will be administered in two injections, three weeks apart.

The decision was based on a study, which has shown that the immune response to 10 µg of the vaccine in this age group was similar to the immune response with the higher dose in people aged 16-25 years. The study looked at almost 2000 5-11-years-olds who had no sign of previous infection. Of the 1305 children receiving the vaccine, three developed COVID-19 compared with 16 out of the 663 children who received placebo, showing an efficacy of 90.7% at preventing symptomatic COVID-19.

The most common side effects in this age group, as in those aged 12 and above, included pain at the injection site, tiredness, headache, injection site reactions, muscle pain, and chills. These effects were usually mild or moderate and improved within a few days.

The CHMP decided that the benefits of using Comirnaty in children aged 5-11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19. The CHMP will now send its recommendation to the European Commission, which will issue a final decision.

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.

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