Pfizer AG applies to Swissmedic for authorisation of a second bivalent COVID-19 vaccine
Bern, 22.09.2022 - Pfizer AG has submitted an application 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.
The updated Comirnaty® vaccine for which the application has been submitted contains half mRNA coding for the spike protein of the original SARS-CoV-2 virus variants (Wuhan) and half mRNA intended to stimulate production of specific neutralising antibodies against Omicron subvariants BA.4 and BA.5. Swissmedic is evaluating the data being submitted on an ongoing basis 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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