BARDA engages Moderna to expand domestic manufacturing of the Moderna SARS-CoV-2 vaccine (mRNA-1273) to protect against COVID-19
BARDA is expanding an existing partnership with MODERNATX, Inc to increase the domestic manufacturing capacity of Moderna’s mRNA-1273 vaccine being developed for the prevention of COVID-19. Expansion activities are expected to begin mid-year to deliver material and could be available as soon as the end of 2020. Moderna has previously announced its new collaboration with Lonza in the United States and this funding supports that manufacturing capacity expansion.
BARDA awarded a contract to ModernaTX on April 16 to accelerate vaccine development through licensure and manufacturing scale-up of mRNA-1273 development initiated with support from support from the National Institutes of Health and CEPI. This vaccine is the first COVID-19 product to transition from NIH to BARDA for advanced development.
The process used to manufacture mRNA-1273 is rapid and scalable. By expanding to additional domestic manufacturing suites (scale-out), the U.S. government can make available more COVID-19 vaccines earlier and faster.
A safe, effective, and deployable vaccine is critical to ending the COVID-19 pandemic, mitigating future waves, and saving lives. The urgency to develop and deploy at least one safe and effective vaccine is critical to saving lives, protecting Americans and reducing the economic impact from this pandemic. Time is of the essence. The Congressional Budget Office estimates that COVID-19 is causing the U.S. to lose approximately $4.48 billion per day in Gross Domestic Product until the U.S. economy can return to the same pre-COVID state of health. A successful vaccine can speed this economic rebound.
Aligned with Operation Warp Speed, BARDA continues to take aggressive action and plan ahead for successful vaccines in order to save lives, protect Americans and aid economic recovery. BARDA is investing to accelerate manufacturing scale-up and deployment of vaccines, in parallel with ongoing clinical development. While large investments in manufacturing and vaccine supplies before FDA approval presents a financial risk, continuing to make these investments is critical to shave months to years off the vaccine development timeline and meet the Administration’s directive to make vaccine available more rapidly.
BARDA will continue to make risk-adjusted investments across the COVID-19 medical countermeasures portfolio, in an effort to accelerate medical countermeasures with the goal of saving lives, protecting Americans, and reducing the long term economic impact of this pandemic.
The U.S. National Institute of Health is conducting the Phase 1 study of mRNA-1273 under an NIH-Investigator New Drug Application (IND). Moderna, with support from BARDA, began a Phase 2 study under Moderna’s own IND in June. Concurrently, NIH, BARDA, and Moderna are finalizing the Phase 3 clinical trial plan. The expansion of domestic manufacture will allow significant manufacturing capacity to produce and make mRNA-1273 available to the US sooner.
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 advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators. Headquartered in Cambridge, Massachusetts, Moderna is a publicly traded company and employs more than 900 people.