The U.S. 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, Mass., 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, according to the news release.
Under the initial 4-year agreement, BARDA will support a Phase 1 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 2 and 3 clinical trials, as well as large scale manufacturing. All of this work is required for the company to apply to the U.S. Food and Drug Administration for vaccine licensure.
“BARDA is taking a three-pronged approach to combat Zika, developing vaccines, diagnostics, and technologies that will protect the blood supply. Today’s agreement with Moderna expands and diversifies our portfolio of candidate vaccines and improves our chances of having a vaccine to provide protection to people and halt the spread of the Zika virus,” said Dr. Richard Hatchett, acting director of BARDA.
Moderna’s vaccine uses messenger RNA, or mRNA, vaccine technology. Messenger RNA is a molecule that carries specific genetic codes to parts of the cell. This type of vaccine uses messenger RNA containing the genetic sequence of the Zika virus to generate an immune response in people.
According to the news release, producing vaccine from this type of technology is rapid compared to other vaccine technologies that require the growth and purification of an attenuated (weakened) or inactivated (killed) virus. Moderna is designing its mRNA vaccine to be easy to administer without any specialized delivery devices.
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.
ASPR partners with other federal agencies, in particular the National Institutes of Health, as well as private industry to develop medical products needed to mitigate the health effects of disasters and other public health emergencies. Potential products may transition from basic research and early clinical trials at NIH to BARDA for support of the advanced development necessary to earn FDA approval or licensure.
With the award, BARDA has obligated all of the $85 million in funds reprogrammed for Zika work that it received in April. These funds are being used to develop Zika vaccine through one of BARDA’s Centers for Innovation in Advanced Development and Manufacturing (CIADM), as well as Moderna’s mRNA vaccine and Takeda’s vaccine, four diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners. In addition, ASPR is providing Zika-positive blood samples to developers to validate the accuracy of new diagnostic tests. These expenditures include:
- $49 million for vaccines
- $20.7 million to develop diagnostics with ChemBio, InBios, OraSure, and DiaSorin
- $10.7 million to develop pathogen reduction technologies with Cerus
- $4.1 million to develop technology to screen donated blood for the Zika virus
- $500,000 for blood sample collection and distribution to developers
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website.