Swissmedic has temporarily authorised “Spikevax Bivalent Original/Omicron (mRNA-1273.214)”, the first COVID-19 vaccine containing messenger ribonucleic acid (mRNA) against two coronavirus variants. In trials, a booster dose with this bivalent vaccine demonstrated higher antibody concentrations against the Omicron variants than a booster with Spikevax®, the original COVID-19 vaccine from Moderna, with comparable side effects. The booster vaccine will be used in accordance with the official vaccination recommendations being drawn up by the Federal Commission for Vaccination (FCV) and the Federal Office of Public Health (FOPH).
Moderna's Spikevax Bivalent Original/Omicron (mRNA-1273.214) authorised from age 18
A careful review of the application documents submitted on an ongoing basis showed that the vaccine meets the safety, efficacy and quality requirements. The external Human Medicines Expert Committee (HMEC) agrees with this assessment by the Swissmedic experts.
The newly authorised vaccine is administered as a single dose of 0.5 ml (50 micrograms). It contains 25 micrograms of mRNA-1273 (original Spikevax) and 25 micrograms of mRNA that targets the Omicron variant (BA.1). Compared to the original vaccine, trials have shown that this produces a stronger immune response against the Omicron variants BA.1 and BA.4/5. The protective effect of the bivalent vaccine against the original SARS-CoV-2 virus (Wuhan type) measured in the antibody concentration is equivalent to the effect of the original vaccine (Spikevax®).
The side effects profile of Spikevax Bivalent Original/Omicron was similar to that seen following administration of the second dose (100 micrograms) or the booster (50 micrograms) of the original vaccine. No new safety signals were found.
As for all new medicinal products that come on to the market, the authorisation holders must continue to provide Swissmedic with ongoing information regarding the safety, efficacy and quality of their authorised COVID-19 vaccines. Swissmedic is continuing to very closely monitor the benefits and risks of all vaccines for preventing COVID-19 disease both in Switzerland and internationally.