The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) www.phe.gov, will begin to develop a vaccine at the Center for Innovation in Advanced Development and Manufacturing (CIADM) http://ciadm.tamhsc.edu located in Baltimore.
Emergent BioSolutions Inc. http://emergentbiosolutions.com announced that CIADM has received a task order from ASPR’s Biomedical Advanced Research and Development Authority (BARDA) www.phe.gov/barda for up to $21.9 million to develop and manufacture the Zika vaccine for use in a Phase 1 Clinical trial.
Emergent BioSolutions will take the first step to study the early stages of vaccine development and then submit an investigational new drug request to FDA www.fda.gov to begin clinical studies.
To speed development, the CIADM will use vaccine technology similar to the technology that was used in developing vaccines to protect against similar viruses. At any stage in development, BARDA will be able to call on CIADM for advice on regulatory, non-regulatory, clinical, nonclinical, and manufacturing processes needed to develop the vaccine.
In addition to the development of the Zika vaccine, BARDA is sponsoring the development of pathogen reduction technologies to reduce the risk from Zika in the blood supply. BARDA is also using their 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. To request a meeting, go to www.medicalcountermeasures.gov.