Zika vaccine on the horizon
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) plans to help bring a vaccine for the Zika virus to market immediately via Emergent BioSolutions Inc., which also developed the anthrax vaccine.
Emergent BioSolutions said that it obtained a contract with ASPR’s Biomedical Advanced Research and Development Authority (BARDA) to develop and manufacture three cGMP lots of a Zika vaccine for use in a phase 1 clinical trial is valued at up to $21.9 million.
“The threat posed by Zika presents an urgent need for vaccines and diagnostics,” said Richard Hatchett, MD, acting BARDA director. “To meet that need as quickly as possible, we need to leverage the infrastructure, experience and expertise available within BARDA, other federal agencies, industry and academia.”
Plus, the first The first US test for the Zika virus became available in early May after Quest Diagnostics received an Emergency Use Authorization (EUA) for its Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test).
Until then, the only Zika tests authorized by FDA were available from the Centers for Disease Control and Prevention (CDC), and were only used in qualified laboratories designated by the CDC.
Emergent Biosolutions will conduct a variety of studies via BARDA’s Center for Innovation in Advanced Development and Manufacturing (CIADM) in Baltimore, to move quickly through early stages of vaccine development and submit an investigational new drug request to FDA to begin clinical studies. To further speed development time, Emergent will use vaccine technology similar to that used in vaccines being developed to protect against similar viruses, such as Dengue.
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Over the next 30 months, BARDA will provide more than $17.9 million to Emergent with the potential for additional work, totaling approximately $21.9 million.
However, at any stage in development, BARDA could transfer the technology to other vaccine manufacturers to utilize the technology to produce and market the Zika vaccine, HHS said.
In addition to this vaccine development, BARDA is sponsoring development of pathogen reduction technologies to reduce the risk from Zika in the blood supply. BARDA also is using its clinical studies network to collect blood samples needed to speed development of diagnostic tests.
BARDA is seeking additional proposals for products that could be used to prevent or detect Zika or other illnesses and injuries associated with public health emergencies. The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) plans to help bring a vaccine for the Zika virus to market immediately via Emergent BioSolutions Inc., which also developed the anthrax vaccine.