Pfizer applies for an authorisation extension for a coronavirus vaccine against Omicron

Comirnaty: Swissmedic starts rolling review of a bivalent COVID-19 vaccine


Pfizer AG has submitted an application to Swissmedic to extend the authorisation for its COVID-19 vaccine Comirnaty, which was originally authorised in December 2020. The bivalent vaccine contains messenger ribonucleic acid (mRNA) both for the spike protein of the Wuhan strain and for that of the Omicron variant. The modified composition promises to be more effective against the Omicron variant of the SARS-CoV-2 coronavirus.

Swissmedic is examining the extension application on a rolling basis. Applicants are not required to include a complete dossier with their initial submission. Instead, they submit the first available data packages along with a schedule for submitting subsequent data packages. Data submitted to date, which are now being reviewed, include the clinical data.

The question of when a benefit-risk decision can be made for the modified vaccine depends on the results of the clinical study data submitted as well as the data relating to quality, which have not yet been submitted. Swissmedic prioritises all applications connected with the COVID-19 pandemic without compromising on the content reviews.

The composition of modified vaccines for combating current and new SARS-CoV-2 variants is being successively evaluated by the World Health Organization (WHO) and the members of the International Coalition of Medicines Regulatory Authorities (ICMRA). The determination of suitable strains for bivalent vaccines contributes to the development of COVID-19 vaccines that are adapted to new virus variants, and hence to making these vaccines available in time and in line with current requirements.

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