Moderna to expand operations outside North America into Switzerland
Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the US government under its Operation Warp Speed program.
By ZACHARY KEYSERA handout photo shows an employee demonstrating a vial with "Gam-COVID-Vac" vaccine against the coronavirus disease (COVID-19), developed by the Gamaleya National Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF), during its production at Binnopharm ph(photo credit: REUTERS)
One of the leading COVID-19 vaccine developers Moderna Inc. announced on Wednesday that they would be expanding operations outside of North America, and begin building a presence in Switzerland after the country secured 4.5 million doses of its investigational mRNA-1273 vaccine.Switzerland will now host a Moderna regional hub as well as a commercial branch within the country, and as created a team to cover divisions such as medical, pricing, regulatory and commercial operations, among others.Along with the international move, Moderna announced that Dan Staner would become the Vice President and General Manager over Swiss operations."I am first and foremost honored to have joined Moderna. I am very excited to have the responsibility for building Moderna’s first commercial organization outside of North America," said Staner. "I look forward to working with Switzerland’s healthcare stakeholders as we face the immediate challenge of COVID-19. This is a wonderful opportunity for Switzerland to continue its leading role in innovation and biopharmaceuticals for the benefit of society globally."Earlier this year, Swiss contract drugmaker Lonza Group AG partnered with Moderna to accelerate the manufacturing of the US drug developer’s potential coronavirus vaccine. Moderna, which enlisted Lonza in May in a 10-year manufacturing contract, is racing with 100-plus other vaccine projects to produce an effective COVID-19 vaccine."Switzerland is a leader in life-sciences, with a dynamic pool of industry talent, scientists, research organizations, investors and global health policymakers," said CEO of Moderna Stéphane Bancel. "Since Moderna’s founding, Switzerland has played an important role in Moderna’s development thanks to the long-term support of our Swiss investors and their business advice. Opening our first subsidiary outside North America in Switzerland is a natural step for Moderna."I am pleased to welcome Dan Staner to the Moderna team," he added. "I had the chance to work with Dan at Lilly and I know that he has a proven track record in building and leading global biopharmaceutical commercial teams in Switzerland and around the world."Moderna’s vaccine candidate - mRNA-1273 - is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who didn’t.If Moderna’s COVID-19 vaccine proves to be at least 70 percent effective, the company plans to seek emergency authorization for its use in high-risk groups, the company’s chief executive told Reuters.Vaccines must demonstrate they are at least 50% more effective than a placebo to be considered for approval. To prove that, government officials have said, at least 150 COVID-19 infections must be recorded among trial participants with at least twice as many occurring among the placebo group.
If a vaccine is especially effective, companies could have their answer sooner.An independent safety board will take a first look at Moderna’s data as soon as a total of 53 people in the trial become infected with COVID-19. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.Moderna released its study protocol on Thursday, making public details on how its vaccine will be evaluated. If the vaccine does not reach the efficacy mark after 53 cases, the data safety and monitoring board will take another interim look at the data after 106 cases, and a final look after 151 people in the trial become infected with the virus.Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the US government under its Operation Warp Speed program. It has also struck a $1.5 billion supply agreement with the United States.Reuters contributed to this report.
