Collaboration Agreement Made to Manufacture COVID-19 Vaccine on a Larger Scale

A new collaboration agreement was made between Moderna, Inc, and Lonza Ltd, to manufacture Moderna’s mRNA vaccine (mRNA-1273) against the coronavirus disease 2019 (COVID-19) on a larger scale, as well as additional Moderna products in the future.¹

The agreement establishes the manufacturing suites for mRNA-1273, which will be located in the United States and Switzerland. The technology transfer between the companies is scheduled to begin in June 2020, and the companies plan to manufacture the first batches of mRNA-1273 in the United States in July 2020.

Over time, the companies plan to maintain additional production sites at Lonza’s facilities internationally, which should allow for the companies to develop to up to 1 billion doses of mRNA-1273 per year, assuming the currently expected dose of 50 µg.¹

Some funding for the manufacturing operations in the United States 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 US Department of Health and Human Services. BARDA will support the late-stage clinical development of mRNA-1273 in the United States.¹

“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, in a press release. “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.”¹

The mRNA-1273 vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health (NIH). The first clinical batch was finished on February 7, 2020, and underwent analytical testing at that time. That first batch was then shipped to NIH on February 24, which was 42 days following the sequence selection.¹

Moderna submitted an Investigational New Drug (IND) application to the FDA for phase 2 and late stage studies of mRNA-1273 on April 27, 2020. The phase 2 study is expected to commence in the second quarter of 2020 and will assess the safety, reactogenicity, and immunogenicity of the 2 vaccinations of mRNA-1273 delivered 28 days apart from each other.

For this phase 2 study, the researchers plan to enroll 600 healthy participants across 2 cohorts of adults aged 18 to 55 years and aged 55 years and older. The researchers will then follow up with the participants in the study 12 months after the second vaccination.¹

REFERENCE

• Moderna and Lonza Announce Worldwide Strategic Collaboration to Manufacture Moderna’s Vaccine (mRNA-1273) Against Novel Coronavirus [news release]. Cambridge, MA: Moderna, Inc. May 1, 2020. businesswire.com/news/home/20200430006085/en. Accessed on May 1, 2020.