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Research programme: Zika virus vaccine - Emergent BioSolutions

Drug Profile

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

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • 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.

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

  1. Emergent BioSolutions Receives BARDA Task Order Valued at Up to $21.9 Million to Develop and Manufacture a Zika Vaccine.

    Media Release
  2. ABL Awarded Subcontract for the Production of an Inactivated Zika Virus Vaccine.

    Media Release
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