The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) began evaluating the application for variation of the marketing authorisation of the COVID-19 vaccine Comirnaty (BioNTech/Pfizer) on 8 February 2022. The subject of the variation to be evaluated is the authorisation of a booster dose of the vaccine in children and adolescents aged 12 to 15 years. The evaluation process for booster vaccination in 16 to 17-year-olds is already underway. Booster vaccinations for those aged 18 and up have been authorised and are in use.
The CHMP at EMA will carry out an accelerated assessment of the data submitted. The results also include data on the use of the vaccine in this age group in Israel.
Booster vaccinations are given to fully vaccinated individuals (i.e. individuals who have completed primary vaccination) to maintain immunity or restore it after it has waned.
After reviewing the data, the CHMP will make a recommendation as to whether the variation should be approved by the European Commission and the product information amended accordingly. The result of this assessment is expected soon.
Updated: 10.02.2022
