Moderna Switzerland GmbH has submitted an application to Swissmedic to extend the authorisation for its COVID-19 vaccine Spikevax®, which was originally authorised in January 2021. 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.
Spikevax®: Swissmedic launches rolling review procedure for a vaccine candidate adapted to SARS-CoV-2 variants (mRNA-1273.214)
Swissmedic is examining the extension application on a rolling basis. Applicants are not required to include a complete dossier with their initial submission to Swissmedic. Instead, they submit the first available data packages along with a schedule for submitting subsequent data packages. Data submitted to date, which are currently being reviewed, include investigations from (preclinical) laboratory studies as well as initial data on manufacturing processes and quality (CMC).
The question of when a benefit-risk decision can be made for the modified vaccine depends on the results of the clinical study data, 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 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.