Swissmedic approves first bivalent Covid-19 booster

Swiss drugs regulator Swissmedic said on Monday that it has approved the first bivalent Covid-19 booster vaccine in the country.

Moderna’s Spikevax vaccine, which contains mRNA against two coronavirus variants, is authorized for anyone 18 years or older, said Swissmedic.

“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),” says a statement issued by Swissmedic.

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).