Application for authorisation of a second bivalent Covid-19 vaccine

22 septembre 2022 – Pfizer AG has applied to Swissmedic for authorisation of a further bivalent Covid-19 vaccine. The ready-to-use dispersion for injection contains both messenger RNA (mRNA) from the original Pfizer/BioNTech Covid-19 vaccine (Comirnaty) and mRNA coding for the spike protein of Omicron variants BA.4 and BA.5. Swissmedic is examining the application for authorisation in a rolling submission procedure. Rolling submission is a special form of authorisation for new active substances that has been adopted in the current pandemic situation. Using the procedure, Swissmedic can review data from ongoing clinical trials as soon as it is available.

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