Swiss drugs regulator Swissmedic announced it has temporarily authorized the first bivalent Covid-19 booster vaccine in the country. That clears the way for an eagerly anticipated second round of booster vaccinations that should better target Omicron sub-variants.

Moderna’s COVID-19 mRNA-1273.214 vaccine, Spikevax, is the first COVID-19 vaccine that contains messenger ribonucleic acid (mRNA) against two coronavirus variants known as BA.1 and BA.4/5, Swissmedic said Monday.

It is authorized for anyone 18 years or older.

“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 agency said.

Federal vaccination and public health officials will now draw up plans to offer the vaccine to the Swiss public. It is administered as a single dose of 0.5 ml (50 micrograms).

Side effects like fever, headaches and muscle pains are “similar to that seen following administration of the second dose (100 micrograms) or the booster (50 micrograms) of the original vaccine,” according to the Swiss regulator.

Booster Meets Safety Standards

The original Moderna vaccine worked against early COVID-19 strains such as Alpha and Delta, but it provided little immunity against Omicron or its sub-variants, which are now causing all of the coronavirus infections that are being detected in Switzerland.

Swissmedic said its review shows the booster vaccine meets the safety, efficacy and quality requirements.

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,” Swissmedic said.

“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),” it said.

The original vaccines were designed to train the body to fight the virus in the form in which it first emerged from Wuhan, China, at the end of 2019. But the virus continues to mutate.

Swiss Booster Approval Follows U.K.

Moderna and Pfizer and BioNTech have submitted applications to the US Food and Drug Administration for emergency use authorization of their updated Covid-19 vaccine boosters.

Both are bivalent vaccines that combine the original vaccines with ones that target Omicron sub-variants BA.4 and BA.5, which are prevalent in the United States.

BioNTech said earlier this month it expects to begin delivering Omicron-adapted vaccines as early as October, subject to regulatory approval.

Two weeks ago, the UK became the first country to approve a bivalent COVID-19 booster vaccine that works against both the original COVID-19 virus and the newer Omicron variant.

An expert panel of advisers to the World Health Organization (WHO) recommended that countries consider a second COVID-19 booster dose for older, at-risk and immunocompromised people, echoing guidance from European and U.S. regulators.

WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization released its updated recommendations for a second vaccine booster dose for all elderly people using age-specific cutoffs to be defined by each country.

It also recommended a second booster for adults with comorbidities that put them at higher risk of severe disease, including pregnant women and health care workers.

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