On Friday, 26 November 2021, the EU Commission granted the extension of the marketing authorisation for BioNTech/Pfizer's COVID-19 vaccine Comirnaty. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) had previously recommended the indication extension. In future, the COVID-19 vaccine 10 micrograms per dose concentrate for injection dispersion from BioNTech/Pfizer can be used from 5 to 11 years of age.
Based on data from a clinical trial involving more than 1,900 children aged 5 to 11 years, the vaccine administered at a concentration of 10 micrograms per dose was shown to reduce the risk of COVID-19 disease by 90.7% in this study. Of 1,305 children in the study who received the vaccine, three developed COVID-19, while 16 of the 663 children who received the placebo developed COVID-19.
The most common side effects experienced by children aged 5 to 11 years are similar to those experienced by people aged 12 years and older: pain at the injection site, tiredness, headache, redness and swelling at the injection site, muscle pain and chills. These reactions are usually mild or moderate and subside within a few days after vaccination.
For children aged 5 to 11 years, the Comirnaty vaccine is specially provided in a separate dosage form in a multi-dose container with an orange cap. Comirnaty 10 micrograms per dose concentrate for the preparation of a dispersion for injection contains 1.3 ml of concentrate, which must be diluted with 1.3 ml of sterile 0.9% saline before administration. The diluted vaccine in the multi-dose container is equivalent to 10 vaccine doses of 0.2 ml each.
Updated: 29.11.2021
