Switzerland Authorizes Moderna’s mRNA COVID-19 Vaccine

Moderna recently announced that Swissmedic, the Swiss Agency for therapeutic products, has authorized its mRNA-based COVID-19 vaccine for use in Switzerland.

The Swiss authorization comes over a month after the federal government increased its confirmed order commitment of mRNA-1273 from 4.5 million to 7.5 million doses. The first allocations are expected to begin in Switzerland in the next week.

“Having our COVID-19 Vaccine Moderna authorized in Switzerland is an important milestone for us,” Stéphane Bancel, chief executive officer and CEO of Moderna, said in the announcement. 

“Switzerland has played a critical role in Moderna’s history since our early days and it means a lot to us that we can now provide a highly effective vaccine to help protect the citizens of Switzerland,” Bancel continued. 

Moderna has also received authorization for its COVID-19 vaccine from regulatory authorities in the US, Canada, Israel, European Union, and, most recently, the UK. Additional authorizations are currently under review in other countries and by the World Health Organization.

Most recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Moderna’s mRNA vaccine for use under Regulation 174.

Regulation 174 is a temporary authorization that allows the supply of mRNA-1273 in Great Britain. Additionally, the UK government will purchase an additional 10 million doses of the vaccine candidate, bringing the total supply to 17 million doses.

The first deliveries of the vaccine to the UK from Moderna’s non-US supply chain are expected to begin early this year. 

This is the third approval from the UK for a COVID-19 vaccine, following the approval of Pfizer and BioNTech’s vaccine at the beginning of December and the approval of AstraZeneca’s vaccine one month later.

The authorization of mRNA-1273 for both Switzerland and the UK is based on a rolling submission of data and the totality of scientific evidence, including data analysis from the clinical Phase 3 study, which was announced at the end of November. 

A primary analysis of Moderna’s COVID-19 vaccine in mid-November found that it met all statistical criteria pre-specified in the study protocol for efficacy in a majority of US participants in a Phase 3 study.

The COVE study enrolled over 30,000 participants in the US and is based on the analysis of COVID-19 cases confirmed and adjudicated two weeks after the second dose of a vaccine. 

Specifically, vaccine efficiency was observed in a total of 196 cases, of which 185 were in the placebo group and 11 were in the mRNA-1273 group. 

A secondary endpoint analyzed 30 severe COVID-19 cases of COVID-19, all of which occurred in the placebo group and none in the group that received the mRNA-1273 injections. The analysis found that the vaccine elicited a 94.5 percent efficiency across 95 cases. 

Notably, the 11 severe COVID-19 cases that were reported all occurred in the placebo group.

Due to the positive trial results, Moderna has developed manufacturing and distribution plans in order to get an approved vaccine into the hands of providers as soon as possible.

At the beginning of January, Moderna released a COVID-19 vaccine manufacturing update for its COVID-19 vaccine, increasing its base-case global production from 500 to 600 million doses for 2021.

The company stated that it hopes to build that estimate to 1 billion doses by the end of 2021 based on continued investments and the addition of more staff.

Nearly 100 million of those doses to be available in the US by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter. 

In total, HHS and the Department of Defense (DoD) will initiate large-scale production and nationwide delivery of a total 200 million doses of mRNA-1273 in the US.