Pfizer applies for indication extension of COVID-19 vaccine to children aged 5 to 11

Swissmedic reviews Pfizer Schweiz AG application for Comirnaty®


COVID-19 mRNA vaccines are currently authorised in Switzerland for children and adolescents aged 12 years and over and recommended by the Federal Commission for Vaccination (FCV). Today, Pfizer Schweiz AG submitted an application to Swissmedic to authorise the COVID-19 vaccine Comirnaty® for children aged 5 to 11. This is the second application for an indication extension to children under 12 years.

Pfizer/BioNTech’s COVID-19 vaccine Comirnaty has been authorised in Switzerland for prevention of COVID-19 disease for adolescents aged 12 years and over since 4 June 2021. Based on the application submitted, the indication should be extended to 5 to 11-year-olds. The application is based on an ongoing clinical trial in 4,600 children in this age group, among other information. Subjects who received the active substance were administered a reduced dose compared to the adult dose.

Swissmedic is fast-tracking all applications connected with the COVID-19 pandemic, without compromising on the content reviews. Once the scientific data, which are being received on an ongoing basis, show that the requirements in terms of efficacy, safety and quality are met in this age group, Swissmedic will swiftly decide on the indication extension.

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