An anxiously awaited vaccine for the fight against Zika may be available sooner rather than later—if its developers and federal health officials get their way.
On September 7, the US Department of Health and Human Services’ (DHHS) Office of the Assistant Secretary for Preparedness and Response announced
that it has awarded an $8.2 million contract to Moderna Therapeutics to “help speed the development of a novel vaccine to prevent the spread of the Zika virus.” Moderna is in the process of developing a vaccine using messenger RNA (mRNA). It is one of a number of vaccines for the mosquito-borne virus currently in development.
“[We are] taking a three-pronged approach to combat Zika, developing vaccines, diagnostics, and technologies that will protect the blood supply,” Richard Hatchett, MD, acting director of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) said in a statement. “[This] 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.”
As part of the 4-year agreement between the government agency and the biotech firm, BARDA will provide Moderna with technical assistance, oversight, and funding to advance the Zika vaccine’s clinical development. This will include support for a Phase I clinical trial as well as toxicology studies, vaccine formulation, and manufacturing. The initial agreement could be extended for up to a total of 5 years (and up to $125 million in additional funding), as needed, to finance Phase II and III clinical trials, as well as large-scale manufacturing, in compliance with US Food and Drug Administration requirements.
Moderna’s vaccine uses mRNA containing the genetic sequence of Zika to generate an immune response. The company hopes to produce a vaccine that is easy to administer without the need for any specialized delivery devices.
With this most recent funding initiative
, BARDA officials say they have obligated all of the $85 million in funds reprogrammed for Zika work that the agency received earlier this year. In all, $49 million has been allocated toward vaccine development and an additional $20.7 million has been spent on efforts to develop diagnostics with private manufacturers such as ChemBio and InBios. The rest of the funds have been earmarked for “pathogen reduction” and blood sample collection and screening.
The Moderna vaccine is slightly further along in the development process than other ongoing efforts. Researchers from the Walter Reed Army Institute for Research have been working with Harvard University scientists, with support from the National Institute for Allergy and Infectious Diseases (NIAID) on the development of a more traditional vaccine against Zika. The group released its preliminary findings
in August. Phase I trials are expected to start before the end of the year. NIAID has also partnered with the non-profit, Sao Paulo, Brazil-based Butantan Institute on the development
of a live attenuated Zika vaccine based on chimeric vaccine technology.
Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous healthcare-related publications. He is the former editor of Infectious Disease Special Edition.
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