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Coronavirus vaccine - Janssen Pharmaceuticals

Drug Profile

Coronavirus vaccine - Janssen Pharmaceuticals

Alternative Names: 'Wuhan coronavirus vaccine - Janssen Pharmaceuticals; 2019-nCoV vaccine - Janssen Pharmaceuticals; COVID-19 vaccine - Janssen Pharmaceuticals

Latest Information Update: 19 Mar 2020

At a glance

  • Originator Janssen Pharmaceuticals
  • Class Viral 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

  • Preclinical COVID 2019 infections

Most Recent Events

  • 30 Mar 2020 Janssen Pharmaceuticals plans to launch Coronavirus vaccine for emergency use authorisation in early 2021
  • 30 Mar 2020 Janssen Pharmaceuticals plans phase I trials for COVID-2019-infections in USA in September 2020
  • 13 Mar 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral)

Development Overview

Introduction

Coronavirus vaccine is being developed by Janssen Pharmaceutical by using its AdVac® and PER.C6® technologies for the treatment and prevention of COVID-2019 infections. AdVac® and PER.C6® technologies helps to increase the production of optimal vaccine candidate. Preclinical development is underway in the US.

Company Agreements

In April 2020, Catalent entered into a manufacturing agreement with the Janssen Pharmaceutical Companies of Johnson & Johnson, to accelerate availability of manufacturing capacity and prepare for large-scale commercial manufacturing for COVID-19 vaccine. The collaboration commits joint investment to accelerate rapid scale-up of segregated manufacturing capacity to support dedicated production of the vaccine [1]

In April 2020, Janssen Pharmaceutical and Emergent BioSolutions entered into an agreement to support manufacturing of COVID-2019 vaccine. The agreement designed to accelerate manufacturing of the vaccine. Johnson & Johnson will invest to expand drug substance capacity related to the vaccine candidate. Emergent will provide drug substance manufacturing services, valued at approximately $US135 million, beginning in 2020, and will reserve operations capacity to potentially support commercial manufacturing of the vaccine leveraging Janssen's proven AdVac® and PER.C6® technologies beginning in 2021. Financial terms of the agreement were not disclosed. [2] [3]

In February 2020, Janssen Pharmaceutical expanded its existing collaboration with Biomedical Advanced Research and Development Authority (BARDA) to seek treatment solutions for COVID-2019 infections. The collaboration will enhance Janssen's ongoing work with global partners to screen a library of existing antiviral molecules, with the aim of identifying compounds with promising antiviral activity against coronavirus. Earlier, in the same month, Janssen Pharmaceutical entered into a collaboration with the BARDA to expedite its new coronavirus vaccine programme. Under the terms of the agreement, Janssen and BARDA will both contribute to the research and development costs and mobilise resources to rapidly advance the initial stages of Janssen's COVID-19 vaccine development programme. BARDA will provide funding to support accelerated development of a vaccine candidate into phase I studies, with options for additional funding to progress a promising candidate. The company will work with the Rega Institute for Medical Research (KU Leuven), in Belgium. The arrangement couples the Institute's infrastructure, breadth of high throughput screening experience, and capabilities for studying special pathogens with Janssen's drug development resources and antiviral expertise. In parallel, Janssen will work to upscale the production and manufacturing capacities required to meet public health needs.
[4] [5]

Key Development Milestones

In March 2020, Janssen Pharmaceutical announced the selection of a lead COVID-19 vaccine candidate from various constructs. The company also announced its intention to initiate vaccine production at risk imminently to make it available on a not-for-profit basis for emergency pandemic use. Earlier in the same month Janssen reported initiation of preclinical testing of multiple vaccine prospects, to identify a coronavirus vaccine for clinical trials [6] [7] .

In January 2020, Janssen Pharmaceutical initiated research on coronavirus vaccine [8] .

Financing information

In March 2020, Johnson & Johnson and BARDA together committed more than $US1 billion for research and development of the coronavirus vaccine. Both the organisations independently provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against coronavirus [6] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E (Viral Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Preclinical USA Parenteral / unspecified Janssen Pharmaceuticals 13 Mar 2020
COVID 2019 infections - - Preclinical USA Parenteral / unspecified Janssen Pharmaceuticals 13 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Janssen Pharmaceuticals Originator USA
Janssen Pharmaceuticals Owner USA
Rega Institute for Medical Research Collaborator Belgium
Beth Israel Deaconess Medical Center Collaborator USA
Biomedical Advanced Research and Development Authority Collaborator USA

Future Events

Expected Date Event Type Description Updated
31 Jan 2021 Regulatory Status Janssen Pharmaceuticals plans to launch Coronavirus vaccine for emergency use authorisation in early 2021 [6] 31 Mar 2020
30 Sep 2020 Trial Update Janssen Pharmaceuticals plans phase I trials for COVID-2019-infections in USA in September 2020 (700318563) [6] 31 Mar 2020

Development History

Event Date Update Type Comment
30 Mar 2020 Regulatory Status Janssen Pharmaceuticals plans to launch Coronavirus vaccine for emergency use authorisation in early 2021 [6] Updated 31 Mar 2020
30 Mar 2020 Trial Update Janssen Pharmaceuticals plans phase I trials for COVID-2019-infections in USA in September 2020 [6] Updated 31 Mar 2020
13 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) [7] Updated 19 Mar 2020
13 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in USA (Parenteral) [7] Updated 19 Mar 2020
18 Feb 2020 Licensing Status Janssen Pharmaceuticals expands its collaboration with the Biomedical Advanced Research and Development Authority (BARDA) for the development of Coronavirus vaccine [5] Updated 24 Feb 2020
11 Feb 2020 Company Involvement Janssen Pharmaceuticals collaborates with the Biomedical Advanced Research and Development Authority (BARDA) for the development of Coronavirus vaccine [4] Updated 14 Feb 2020
11 Feb 2020 Trial Update Janssen Pharmaceuticals plans phase I trials for COVID-2019-infections in USA [4] Updated 14 Feb 2020
30 Jan 2020 Phase Change Early research in COVID-2019-infections (Prevention) in USA (Parenteral) [8] Updated 04 Feb 2020
30 Jan 2020 Phase Change Early research in COVID-2019-infections in USA (Parenteral) [8] Updated 04 Feb 2020

References

  1. Catalent Signs Agreement with Johnson & Johnson to be U.S. Manufacturing Partner for Lead COVID-19 Vaccine Candidate.

    Media Release
  2. Johnson & Johnson Announces Collaboration to Expand Manufacturing Capabilities For its COVID-19 Vaccine Candidate in Support of the Company's Goal to Supply More Than One Billion Vaccine Doses Globally.

    Media Release
  3. Emergent BioSolutions Signs Agreement to be U.S. Manufacturing Partner for Johnson & Johnsons Lead Vaccine Candidate for COVID-19.

    Media Release
  4. Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine.

    Media Release
  5. Johnson & Johnson to Expand Partnership with U.S. Department of Health & Human Services to Accelerate the Discovery of Potential COVID-19 Treatments.

    Media Release
  6. Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use.

    Media Release
  7. Johnson & Johnson Announces Collaboration with the Beth Israel Deaconess Medical Center to Accelerate COVID-19 Vaccine Development.

    Media Release
  8. Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat.

    Media Release
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