Moderna Signs 10-Year Deal with Lonza for Manufacturing One Billion COVID-19 Vaccine Doses per Year

Moderna, Inc. (Cambridge, MA, USA) and Lonza (Basel, Switzerland) have entered into a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s messenger RNA vaccine (mRNA-1273) against the novel coronavirus.

mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The company recently submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for Phase 2 and late stage studies of mRNA-1273 if supported by safety data from the Phase 1 study. Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which is expected to begin in the second quarter of 2020. This study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.

Lonza’s manufacturing facilities complement Moderna’s ongoing US manufacturing efforts, which continue to ramp up to prepare for the further clinical development and commercialization of mRNA-1273. A portion of the funding for the establishment of manufacturing operations at Lonza US is covered by Moderna’s contract with Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, which was announced April 16, 2020. BARDA will support late-stage clinical development programs of mRNA-1273. Lonza’s experience in scaling manufacturing of innovative medicines, including support for more than 50 commercial approvals across regulatory jurisdictions, will support Moderna for global supply.

Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the US and Switzerland for the manufacture of mRNA-1273 at both sites. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza US in July 2020. Over time, the parties intend to establish additional production suites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to one billion doses of mRNA-1273 per year for use worldwide assuming the currently expected dose of 50 µg.

“We are very pleased to partner with Lonza, which shares our commitment to rapidly addressing this pandemic which has created a global health crisis,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “This long-term strategic collaboration agreement will enable Moderna to accelerate, by 10-times, our manufacturing capacity for mRNA-1273 and additional products in Moderna’s large clinical portfolio. Lonza’s global presence and expertise are critical as we scale at unprecedented speed. Our common goal is to potentially enable manufacturing of up to 1 billion doses of mRNA-1273.”

“Moderna’s technology represents a significant opportunity to change the way we protect people against disease,” said Albert M. Baehny, Lonza’s Chairman and CEO ad interim. “The current pandemic illustrates the need to combine the best science with resilient supply chains that can scale. We are fully committed to leveraging our global network and experience in manufacturing technologies to support Moderna’s manufacture of mRNA-1273 as well as collaborating on future Moderna products.”

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