Research programme: Zika virus vaccine - Emergent BioSolutions
Latest Information Update: 28 Sep 2020
At a glance
- Originator Unknown
- Developer Emergent BioSolutions
- Class Synthetic vaccines; Zika virus vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- No development reported Zika virus infection
Most Recent Events
- 28 Sep 2020 No recent reports of development identified for preclinical development in Zika-virus-infection in USA
- 04 Aug 2016 Preclinical trials in Zika virus infection in USA (unspecified route)
- 27 Jun 2016 Emergent BioSolutions receives a task order from the Biomedical Advanced Research and Development Authority for the development of a Zika virus vaccine
Development Overview
Introduction
Emergent BioSolutions is developing a vaccine for the prevention of Zika virus infection. Preclinical development is underway in the US.
The vaccine is being developed using a base created by an undisclosed organisation.
VLA 1601, a highly purified inactivated vaccine for the prevention of Zika virus infections, has entered clinical development [see AdisInsight drug profile 800051396].
As at September 2020, no recent reports of development had been identified for preclinical development in Zika-virus-infection in USA.
Company Agreements
In June 2016, Emergent BioSolutions received a task order worth up to $US21.9 million, including a 30-month base value of $US17.9 million, from the Biomedical Advanced Research and Development Authority (BARDA), for the development and manufacture of a Zika vaccine. The Center for Innovation in Advanced Development and Manufacturing (CIADM) led by the company will be responsible for development of three cGMP lots of the vaccine for use in phase I trials, as well as submission of an IND application with the US FDA. BARDA will provide the company with a base vaccine, and will fund the vaccine programme [1] .
Manufacturing agreement
Emergent BioSolutions, in August 2016, awarded a sub-contract to ABL for the GMP production, assay development, as well as release and stability testing services, for production of an inactivated Zika virus vaccine for use in phase I studies [2] .
Drug Properties & Chemical Synopsis
- Formulation unspecified
- Class Synthetic vaccines, Zika virus vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E9 (All other viral vaccines)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Zika virus infection | - | - | No development reported (Preclinical) | USA | unspecified / unspecified | Emergent BioSolutions | 28 Sep 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Unknown | Originator | USA |
| Unknown | Owner | USA |
| Biomedical Advanced Research and Development Authority | Funder | USA |
| Emergent BioSolutions | Collaborator | USA |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Sep 2020 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Zika-virus-infection in USA Updated 28 Sep 2020 |
| 04 Aug 2016 | Phase Change - Preclinical | Preclinical trials in Zika virus infection in USA (unspecified route) Updated 15 Sep 2016 |
| 27 Jun 2016 | Company Involvement | Emergent BioSolutions receives a task order from the Biomedical Advanced Research and Development Authority for the development of a Zika virus vaccine [1] Updated 15 Sep 2016 |
References
-
Emergent BioSolutions Receives BARDA Task Order Valued at Up to $21.9 Million to Develop and Manufacture a Zika Vaccine.
Media Release -
ABL Awarded Subcontract for the Production of an Inactivated Zika Virus Vaccine.
Media Release
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