- Moderna struck a 10-year collaboration with Swiss drug manufacturer Lonza in a bid to help meet what could be — should clinical tests prove positive — intense demand for its experimental coronavirus vaccine, mRNA-1273.
- The deal will enable Moderna to make up to 1 billion doses of mRNA-1273 per year at the dose it hopes to bring to market. Moderna will set up manufacturing suites at Lonza facilities in the U.S. and Switzerland, and make the first batches of mRNA-1273 at the U.S. site starting in July.
- Moderna's vaccine is at the forefront of a race to develop treatments that prevent infection with SARS-CoV-2. The competition includes massive drugmakers like Johnson & Johnson, Sanofi, GlaxoSmithKline and Pfizer — which is partnered with Moderna rival BioNTech — that are experienced in making vaccines on a global scale.
The global race to develop a coronavirus vaccine has gotten considerably more hurried over the past month. Multiple vaccine candidates developed in China, Europe, and the U.S. began human tests, kicking off a slate of clinical trials that could decide, ultimately, how long the pandemic will broadly impact day-to-day life. Dozens of additional programs could soon follow.
Moderna was one of the first to get there with its experimental vaccine, called mRNA-1273. A Phase 1 trial began in March, just two months after the company began working on the program — a testament to the potential of mRNA vaccine technology, which, while unproven, can be designed and produced faster than their protein-based counterparts.
Since that time, the path forward has come into focus for Moderna. Assuming positive results in the early study, which is meant to show if mRNA-1273 is safe, Moderna aims to start a more rigorous trial in the second quarter to test whether the vaccine can trigger immune responses against the virus. It disclosed the design of that trial this week: two shots of mRNA-1273, 28 days apart, for 600 healthy volunteers who get either a placebo or a low (50 micrograms) or high (250 micrograms) dose of the vaccine. Half of those patients will be 18 to 55 years old, the other half older than 55.
Positive results could lead to pivotal studies that begin in the fall, which would give Moderna a chance to meet the ambitious 12- to 18-month timeline often cited by National Institute of Allergy and Infectious Diseases director Anthony Fauci for when a vaccine might be available to the general public.
A lot has to go right for Moderna to get there, however. There has never been a vaccine for any coronavirus. And many vaccine developers have based their designs on previous research into other coronaviruses, like SARS or MERS, which share genetic similarities with SARS-CoV-2, but differences as well. Much still remains unknown about the novel coronavirus, and how our bodies respond to infection.
Nonetheless, given the urgency of the coronavirus outbreak, companies are operating at breakneck speed to both run trials and prepare for potential drug launches. That's easier for pharma giants like Johnson & Johnson, Sanofi, GlaxoSmithKline, AstraZeneca and Pfizer. Each are either helping others develop vaccines or advancing their own, and each have experience making and distributing medicines globally. But it's a tougher task for Moderna, which, while much larger than the typical clinical-stage biotech, hasn't yet launched a product — let alone a vaccine during a global pandemic.
The Lonza deal should help solve that problem. Using a portion of the $483 million contract the U.S. government awarded Moderna in April, the Swiss drug manufacturing giant will set up suites at its U.S. and Switzerland facilities to make batches of mRNA-1273, starting in July. More sites will be added afterwards, and the deal includes manufacturing assistance for future Moderna products as well.
The help will "accelerate, by 10 times," Moderna's manufacturing capacity for mRNA-1273, meaning it could make potentially up to 1 billion doses per year, CEO Stéphane Bancel said in a statement. But that figure assumes Moderna's 50-microgram dose of mRNA-1273 is successful, making its performance in human tests critical to watch.