Lonza, Moderna in Pact to Manufacture One Bn Doses of COVID-19 VaccineBy
Lonza and Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, have formed a 10-year pact to enable manufacturing of up to one billion doses per year of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional future Moderna products.
Late last month (April 2020), Moderna announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services to accelerate development of the company’s mRNA vaccine candidate, mRNA-1273, against the novel coronavirus. A Phase I study of mRNA-1273, which began on March 16, 2020, is being conducted by the US National Institutes of Health.
Under the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the US and Switzerland for the manufacture of mRNA-1273. 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. The companies intend to establish additional production suites across Lonza’s facilities to allow for the manufacture of material equivalent to up to one billion doses of mRNA-1273 per year assuming the currently expected dose of 50 µg. The companies say the manufacturing facilities at Lonza will assist Moderna’s ongoing US manufacturing efforts in preparation for further clinical development and commercialization of mRNA-1273.
Moderna announced on April 27, 2020 that it submitted an investigational new drug application to the US Food and Drug Administration (FDA) for Phase II and late-stage studies of mRNA-1273 if supported by data from the Phase I study. Moderna says it has received initial feedback from the FDA on the design of the planned Phase II study, which is expected to begin in the second quarter of 2020.
A portion of the funding for the establishment of manufacturing operations at Lonza US is covered by Moderna’s contract with BARDA. BARDA will support late-stage clinical development programs of mRNA-1273.