COVID-19 vaccine from Pfizer/BioNTech: Swissmedic approves the extension of the booster dose to everyone aged 16 years and over

Bern, 23.11.2021 - After reviewing the recently submitted data, Swissmedic is adapting the information for healthcare professionals for the COVID-19 mRNA vaccine from Pfizer/BioNTech (Comirnaty®). This clears the way for wider use of the booster vaccination. High-risk individuals can still obtain a booster dose from age 12.

Swissmedic has reviewed the documentation submitted by the marketing authorisation holder last week and is adapting the product information. Individuals aged 16 years and over can now be administered a booster dose. As stipulated in the Swissmedic decision of 26 October 2021, high-risk individuals can still obtain the booster from age 12. In both cases, however, the second dose must have been administered at least six months previously.

Third vaccination with the same dose

Swissmedic reached this decision based, among other factors, on a study with 10,000 participants aged 16–87. The interim results of this study gave no indication of new risk aspects for the vaccine. Basic immunisation with Comirnaty involves two doses of 0.3 ml administered at an interval of three weeks. The booster vaccination at least six months later that has now been approved can maintain protection against COVID-19 disease.   

Use and safety of COVID-19 vaccines

Based on the changes made by Swissmedic to the product information, the Federal Commission for Vaccination (FCV) is now specifying detailed vaccination recommendations. Swissmedic continues to monitor very closely the benefits and risks of the vaccine for preventing COVID in Switzerland and internationally.

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