Logo newsbot.ch


Pfizer AG applies to Swissmedic for authorisation of a second bivalent COVID-19 vaccine

2022-09-22 15:45:14
newsbot by content-proivder.ch GmbH
Quelle: Swiss Federal Council

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..

Suche nach Stichworten:

Pfizer applies Swissmedic authorisation second bivalent COVID-19 vaccine


Swiss Federal Council

Switzerland and the World Bank step up their support for developing countries to cope with the impact of the pandemic

Swiss Federal Council

Federal Council commissions revision of Financial Market Infrastructure Act

Swiss Federal Council

Swiss retail trade turnover rose in August 2022 by 5.4%

Swiss Federal Council

Kurzarbeitsentschädigung: Gesuche für Nachzahlung neu bis 31. Dezember 2022 möglich

Swiss Federal Council

Switzerland streamlines its engagement with the international commodity organisations