Comirnaty® (BNT162b2) is the first vaccine against COVID-19 approved in Europe for adults and adolescents from 16 to 18 years of age.

Data on efficacy and safety of the vaccine in children under 16 years of age is still not available. The company has agreed that paediatric studies will be completed by July 2024, as included in the Paediatric Investigational Plan – PIP (EMEA-002861-PIP02-20) according to the European Paediatric Regulation.

It is common Knowledge that medicines should not be tested only in adults. Children, indeed, have different and specific characteristics that should be considered when a new medicine or vaccine is developed. Therefore, ad hoc clinical studies on children shall be designed.

The PIP for Comirnaty® foresees that 4 clinical studies shall be conducted to gather needed evidence on the dosage, safety, tolerability and immunogenicity of the vaccine including children from birth to less than 18 years of age.

The company completed enrolling children aged 12 to 15 in the first study (NCT04368728) that aims to evaluate the safety, tolerability, immunogenicity, and efficacy of BNT162b2 vaccine. Over 2200 participants aged 12-15, as agreed in the PIP, were enrolled until January 2021.

Visit our COVID-19 page to keep you updated on the next steps.