Pfizer applies for indication extension of COVID-19 vaccine to include children aged 6 months to less than 5 years

Swissmedic reviews Pfizer Schweiz AG application for Comirnaty®

02.09.2022

This week, Pfizer Schweiz AG submitted an application to Swissmedic to authorise the COVID-19 vaccine Comirnaty® for children aged 6 months to less than 5 years.

Pfizer/BioNTech’s COVID-19 vaccine Comirnaty has been authorised in Switzerland for prevention of COVID-19 disease for children aged 5 years and older since 10 December 2021. Based on the trial data submitted, the indication is to be extended to include children aged between 6 months and under 5 years.

The COVID-19 vaccine for children is given in two doses three weeks apart for basic immunisation. The dosage is lower than for children aged 5 years and over: instead of 10 micrograms, one dose contains 3 micrograms of mRNA following appropriate dilution.

So that the vaccine for children aged 6 months to less than 5 years can be distinguished from the other formulations, the vials will have a maroon cap and the packaging of the proposed formulation will also have maroon markings.

 

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