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September 9, 2016
On Sept. 7, 2016, the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced an $8.2-million contract award to Moderna Therapeutics of Cambridge, Massachusetts, to help speed the development of a novel vaccine to prevent the spread of the Zika virus. ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide technical assistance, oversight, and funding to advance the Zika vaccine’s clinical development.
Under the initial four-year agreement, BARDA will support a Phase I clinical trial, toxicology studies, vaccine formulation, and manufacturing. If additional funding is identified, the agreement could be extended up to a total of five years and a total of $125.5 million to support Phase II and III clinical trials, as well as large-scale manufacturing.
Moderna’s vaccine uses messenger RNA (mRNA) vaccine technology. mRNA is a molecule that carries specific genetic codes to parts of the cell. This type of vaccine uses mRNA containing the genetic sequence of the Zika virus to generate an immune response in people. Producing vaccine from this type of technology is rapid compared to other vaccine technologies that require the growth and purification of an attenuated or inactivated virus.
This new mRNA Zika vaccine development project is part of ASPR/BARDA’s comprehensive integrated portfolio approach for advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to emerging infectious diseases, these threats include pandemic influenza, chemical, biological, radiological, and nuclear agents, and antimicrobial resistant pathogens.