BARDA and Moderna will collaborate to accelerate the development of SARS-CoV-2 mRNA-1273 vaccine which includes non-clinical development and advanced clinical studies, regulatory support through licensure and process development for manufacturing.
Vaccination is critical for the reduction of infection rates, severity of disease and mortality due to COVID-19.The Moderna mRNA vaccine platform is rapid and scalable and early clinical trials have already begun with support by NIH.
Moderna will advance the vaccine candidate into expanded clinical studies to extend the size of the safety data base. The cumulative safety dataset generated in early clinical trials is expected to be sufficient to advance the vaccine. A pivotal advanced stage clinical study will be conducted in approximately 10,000 subjects. The feasibility of a clinical efficacy study for licensure is dependent on the incidence of COVID-19 and will require discussion with global health and regulatory authorities. If current rates of transmission are sustained, a clinical study of the proposed size could be sufficient to demonstrate efficacy. Moderna’s manufacturing facility in Norwood, Massachusetts has the capacity to develop mRNA-formulated lipid nanoparticles (fLNPs), the vaccine delivery system, through product launch. Parallel activities will be undertaken to expand vaccine production in the United States in preparation for large scale production as soon as the vaccine has met regulatory requirements.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
Moderna Inc. is a leader in the discovery and development of messenger RNA (mRNA) vaccines and therapeutics. With a breakthrough platform technology, Moderna is creating mRNA medicines for a wide range of diseases and conditions. These innovative mRNA medicines are being developed for infectious diseases, immuno-oncology, rare diseases, and cardiovascular diseases, through its own programs and collaborations with strategic partners. Founded in 2011 and headquartered in Cambridge, Massachusetts, Moderna is a publicly traded company and employs over 800 people to develop the mRNA platform technology.