Bern, 22.09.2022 - Pfizer AG has submitted an application to Swissmedic for authorisation of a further bivalent COVID-19 vaccine, writes the Swiss Federal Council.
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. Any change to a medicinal product can affect its safety, efficacy or quality.
Swissmedic is carefully examining the scientific data submitted. Specifically, the documentation must demonstrate that bivalent COVID-19 vaccines are just as effective against original virus strains as the previous vaccines and that safety has been established.
Furthermore, an additional benefit in respect of the new virus variants – in the case of SARS-CoV-2, Omicron BA.4 and BA.5 – must be demonstrated..
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