Reports of formation of bubbles in a batch of the COVID-19 vaccine Comirnaty Bivalent Original/Omicron BA.1 - risks currently being investigated
Bern, 02.11.2022 - Swissmedic has been informed of the appearance of bubbles during preparation of the vaccine Comirnaty Bivalent Original/Omicron BA.1. Swissmedic is examining the potential risks in connection with the changes observed. As a precautionary measure, Swissmedic has informed the cantons and vaccination centres.
Swissmedic has been informed by vaccination centres of the appearance of bubbles during preparation of the vaccine Comirnaty Bivalent Original/Omicron BA.1. Vials of the batch concerned contained bubbles after being removed from the fridge. Swissmedic is evaluating possible causes together with the marketing authorisation holder and also analysing samples in its own laboratory.
According to current knowledge, the phenomenon seems to be accentuated when the syringes are prepared several hours in advance. Some vials already contain bubbles when they are removed from the fridge. As a precautionary measure, Swissmedic has informed the cantons and vaccination centres. Swissmedic will issue updates on the situation and measures to be taken through this communication channel as soon as further findings are available.
Important information for vaccination centres
As a precautionary measure and until the causes have been clarified, all syringes should be visually checked before injection. Any products containing bubbles or particles should not be administered. In addition, it is recommended that syringes for the vaccine are not drawn up more than 15 minutes in advance.
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