On 4 June 2021, Swissmedic, Switzerland’s drug approval authority, announced it was extending authorisation of the Pfizer/BioNTech vaccine to 12-15 year olds.
The vaccine, also known under the brand name Comirnaty®, has had temporary ordinary authorisation for use in Switzerland on people aged 16 or over since 19 December 2020.
Swissmedic started looking at approving the vaccine for use on younger people on 7 May 2021 and reviewed the application for extension in an accelerated rolling procedure. The vaccine showed close to 100% efficacy in the clinical trial for the investigated age group.
The same vaccine was approved for use on 12-15 year olds in the US on 12 May 2021 and in the UK on 4 June 2021.
The side effects in 12-15 year olds corresponded to the adverse reactions reported in clinical trials with 16-25 year-olds and adults. The most frequent ones were pain at the injection site, fatigue, headache, shivering, muscle pain, fever and joint pain. The side effects usually lasted between one and three days, and may be more pronounced after the second dose.
By 6 June 2021, 64 doses of Covid-19 vaccine per 100 had been administered in Switzerland and 40% of the population had received at least 1 dose.
Swissmedic press release (in French) – Take a 5 minute French test now
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