The Mission of Medical Countermeasure Systems (MCS) – Joint Vaccine Acquisition Program (JVAP) is to develop, produce and stockpile Food and Drug Administration (FDA)-licensed vaccine systems to protect the warfighter from biological agents. The JVAP portfolio consists of:
Anthrax Vaccine Absorbed is the only Food and Drug Administration (FDA)-licensed anthrax vaccine in the United States that provides protection against cutaneous, gastrointestinal and aerosol infection by battlefield exposure to Bacillus anthracis.
Recombinant Plague Vaccine (PLG VAC) is a highly purified polypeptide produced from bacterial cells transfected with a recombinant vector from the Yersinia pestis bacterium formulated with an aluminum hydroxide adjuvant and delivered intramuscularly to prevent pneumonic plague.
Recombinant Botulinum Toxin Vaccine A/B (BOT VAC A/B) is comprised of nontoxic botulinum toxin heavy chain fragments of serotypes A and B formulated with an aluminum hydroxide adjuvant and delivered intramuscularly prior to potential exposure to botulinum toxin.
Smallpox Vaccine System provides both the ACAM2000™smallpox vaccine and the Vaccinia Immune Globulin, Intravenous (VIGIV) to vaccinate and protect the warfighter from potential exposure to smallpox. Both products are FDA approved.
Filovirus Vaccine (FILO VAC) addresses an essential capability gap for protecting warfighters against aerosolized filovirus for which there is no current therapeutic. Target filovirus strains include Ebola Sudan, Ebola Zaire and Marburg.
Western, Eastern, Venezuelan Equine Encephalitis Vaccine (WEVEE VAC) addresses an essential capability gap for protecting warfighters against aerosolized alphavirus for which there is no current therapeutic. Target alphavirus strains include Venezuelan, Eastern and Western Equine Encephalitis.
BENEFIT TO THE SOLDIER
JVAP provides protection to the warfighter against aerosolized biological warfare agents.
- System attributes established in requirements documentation
- PLG VAC FDA granted Orphan Drug Designation resulting in cost reductions incentives
- FILO VAC Completed Ebola vaccine Phase 1 human clinical trial
- BOT VAC A/B Milestone C
- WEVEE VAC Other Transaction Authority agreement award for VEE development
- FILO VAC Initiation of VEE Phase 1 human clinical trial
- Initiation of Ebola vaccine Phase 2 human clinical trial
- Plague VAC: Consistency lot manufacturing data, End of Phase 2 Clinical Trial data, Pre-Biologics License Application submission data, End of Phase 2 Meeting, Milestone C, FDA Licensure
- Botulinum VAC: Consistency lot manufacturing data, End of Phase 2 Clinical Trial data, Pre-BLA submission data, Milestone C, FDA Licensure
Filovirus VAC: Capability Development Document (CDD) Validation, Phase 1 Clinical Trial safety and immunogenicity data, Proof of concept animal efficacy data, Milestone B
- WEVEE VAC: CDD Validation, Pre-Investigational New Drug submission data, End of Phase 1 Clinical Trial data, Proof of Concept animal efficacy data, Good Manufacturing Practices Drug Product stability test data, Milestone B