Australia’s trusted independent immunisation experts

 

In response to the COVID-19 pandemic, our policy support team has been closely monitoring publicly available information on COVID-19 vaccine candidates. We have used information from international platforms, including the World Health Organization (WHO) and the Coalition of Epidemic Preparedness and Innovations (CEPI), national regulatory institutes, clinical trial registries, vaccine developers and manufacturers, and scientific literature to develop the content on this page. Our focus is to understand the current state of development of COVID-19 vaccines and clinical trials. We update this page weekly.

2 Dec

 

Figures are based on the WHO document Draft landscape of COVID-19 candidate vaccines and monitoring of clinical trials registries. Only those vaccine candidates that have commenced recruiting participants for human clinical trials are counted in our global snapshot.

The Milken Institute COVID-19 Vaccine Tracker and others identify more vaccines (including therapeutic and prophylactic vaccines).

  • COVID-19 vaccines in clinical trials globally

    Candidate vaccines must be tested in preclinical, phase I, phase II, phase III clinical trials before they are licensed and available to the public. For further explanation, refer to Phases of clinical trials page. Traditionally it takes at least 10 years from development to licensure of a vaccine. The pandemic has pushed for an accelerated approach to vaccine development. Several candidate vaccines have moved into the next stage of clinical trials before completion of earlier stage trials.  

    There are several vaccine platforms that are being used for the development of COVID-19 vaccines. These include long-established technologies such as live attenuated virus/ inactivated virus and protein vaccines. More modern methods such as viral vector vaccines and nucleic acid vaccines are also being used to develop COVID-19 vaccines. Refer to Vaccine platforms page for an explanation of different vaccine platforms. 

    Below are candidate vaccines that are currently in clinical trials. Some candidates are undergoing multiple trials in different phases. 

    Phase 3
    Vaccine Developer Clinical trial in Vaccine platform Number of participants Age range
    ChAdOx1 nCoV-19 University of Oxford Brazil Viral vector  5,000 ≥18 years
    CoronaVac Sinovac Biotech Brazil Inactivated 8,870 ≥18 years
    CoronaVac Sinovac Biotech Turkey Inactivated 13,000 18-59 years
    Unnamed Wuhan Institute of Biological Products United Arab Emirates, Bahrain, Egypt and Jordan Inactivated 45,000 ≥18 years
    Unnamed Beijing Institute of Biological Products United Arab Emirates, Bahrain, Egypt and Jordan Inactivated 45,000 ≥18 years
    Unnamed Beijing Institute of Biological Products Argentina Inactivated 3,000 ≥18-85 years
    mRNA-1273           Moderna USA RNA 30,000 ≥18 years

    BNT162b2

    BioNTech/Pfizer USA RNA 43,998 ≥18 years
    CoronaVac Sinovac Biotech Indonesia Inactivated 1,620 18-59 years
    AZD1222/ChAdOx1 nCoV-19  AstraZeneca/University of Oxford                 USA Viral vector 40,051 18-130 years 
    Gam-COVID-Vac Gamaleya Research Institute  Russia Viral vector 40,000 18-111 years
    Ad5-nCoV CanSino Biologics Russia Viral vector 500 18-85 years
    Ad5-nCoV CanSino Biologics Multiple countries Viral vector 40,000 ≥18 years 
    Ad26.CoV2.S Janssen Three continents Viral vector 60,000 ≥18 years
    NVX-CoV2373 Novavax UK Protein 10,000 18-84 years
    Gam-COVID-Vac

    Gamaleya Research Institute

    Belarus Viral vector 100 18-60 years
    Unnamed Beijing and Wuhan Institute of Biological Products Peru Inactivated 6,000 18-60 years
    CoronaVac Sinovac Biotech China Inactivated 1,040 ≥18 years
    BBV152/Covaxin Bharat Biotech International India Inactivated         25,800 18–99 years
    Ad26.COV2.S Janssen Multiple countries Viral vector 30,000 ≥18 years
    Phase 2 &3
    Vaccine Developer Clinical trial in Vaccine platform Number of participants Age range
    ChAdOx1 nCoV-19 University of Oxford UK Viral vector 10,560 5–12 years and ≥18 years
    ChAdOx1 nCoV-19 University of Oxford India Viral vector 1,600 18–99 years
    CoVLP Medicago     Canada     Virus-like particle 30,612 ≥18 years
    Phase 2
    Vaccine Developer Clinical trial in Vaccine platform Number of participants Age range
    Ad5-nCoV CanSino Biologics China Viral vector 500 ≥18 years
    mRNA-1273 Moderna/NIAID       USA   RNA       600  ≥18 years
    Unnamed Anhui Zhifei Longcom Biopharmaceuticals China Protein         900 18–59 years
    NVX-CoV2373 Novavax (USA) South Africa Protein         2,904 18–64 years
    CVnCoV CureVac Peru and Panama RNA 690 18–60 years
    Gam-COVID-Vac  Gamaleya Research Institute Russia Viral vector 110 60–111 years
    Phase 1&2
    Vaccine Developer Clinical trial in Vaccine platform Number of participants Age range
    ChAdOx1 nCoV-19             University of Oxford UK Viral vector 1,090  18–55 years
    ChAdOx1 nCoV-19                  University of Oxford (UK) South Africa Viral vector 2,000  18–65 years
    Ad5-nCoV               CanSino Biologics (China)  Canada     Viral vector 696  18–85 years
    CoronaVac                Sinovac Biotech   China Inactivated   Phase I: 144 phase II: 600 18–59 years

    CoronaVac

    Sinovac Biotech China  Inactivated     Phase I: 72
    Phase II: 350
    ≥60 years
    BNT162                BioNTech  Germany    RNA 196   18–55 years

    Unnamed

    Beijing Institute of Biological Products  China   Inactivated     Phase I: 480
    Phase II: 1,168
    ≥3 years

    Unnamed

    Wuhan Institute of Biological Products China   Inactivated     Phase I: 288
    Phase II: 1,168
    ≥6 years
    NVX-CoV2373                   Novavax (US)  Australia Protein 125 18–89 years
    Unnamed Chinese Academy of Medical Sciences  China Inactivated 942  18–59 years
    Unnamed Chinese Academy of Medical Sciences China Inactivated 471 ≥60 years
    INO-4800                 Inovio (USA)  South Korea DNA  160   19–64 years

    GX-19

    Genexine Consortium South Korea DNA Phase I: 40
    Phase II: 150
    18–50 years
    Unnamed             Cadila Healthcare Limited  India   DNA   1,048   ≥12 years
    AG0301-COVID19                    AnGes Inc Japan DNA 30  20–65 years
    AG0302-COVID19 AnGes Inc Japan DNA 30  20–65 years

    BBV152                   

     

    Bharat Biotech International India Inactivated  Phase I: 375
    Phase II: 750
    Phase I: 18–55 years
    Phase II: 12–65 years
    ARCT-021 Arcturus Therapeutics Singapore RNA 85 21–80 years
    AD26.COV2.S Janssen Pharmaceuticals USA and Belgium Viral vector 1,045 ≥18 years

     FINLAY-FR-1

    Finlay Vaccine Institute Cuba Protein 676 19–80 years
    QAZCOVID-IN Research Institute for Biological Safety Problems Kazakhstan Inactivated Phase I: 44
    Phase II: 200
    Phase I: 18–50 years
    Phase II: ≥18 years
    EpiVacCorona Federal Budgetary Research Institution State Research Centre of Virology and Biotechnology Russia     Protein     100 18–60 years
    AdimrSC-2f Adimmune Corporation Taiwan Protein     70 20–60 years
    Unnamed Sanofi Pasteur/GSK USA Protein     440 ≥18 years
    RBD-SARS-CoV-2 HBsAg VLP SpyBiotech/Serum Institute of India Australia Virus-like particle 280 18–79 years
    V591 Merck Belgium Viral vector 260 ≥18 years
    ChAdOx1 nCoV-19/AZD 1222   University of Oxford/AstraZeneca Japan Viral vector 256 18–55, 56–69, ≥70 years
    IIBR-100 Israel Institute of Biological Research Israel Viral vector 1,040 18-85 years
    CoronaVac Sinovac Biotech China Inactivated 552 3–17 years
    ChAdOx1 nCoV-19 University of Oxford Kenya Viral vector 200 18-55 years
    BNT162b2 BioNTech/Pfizer Japan RNA 160 20–85 years
    BECOV Biological E India Protein 360 18–65 years
    Phase 1
    Vaccine Developer Clinical trial in Vaccine platform Number of participants Age range
    Ad5-nCoV               CanSino Biologics  China      Viral vector 108 18–60 years
    mRNA-1273            Moderna      USA   RNA 105  18–99 years
    INO-4800      Inovio USA     DNA     40 18–50 years
    LNP-nCoVsaRNA                Imperial College London UK   RNA  320   18–75 years
    Gam-COVID-Vac                  Gamaleya Research Institute  Russia Viral vector   38 18–60 years
    Gam-COVID-Vac-Lyo Gamaleya Research Institute Russia Viral vector 38 18–60 years
    SCB-2019                   Clover Biopharmaceuticals (China) Australia Protein  150  18–75 years
    Unnamed                 Anhui Zhifei Longcom Biopharmaceuticals China  Protein 50   18–59 years
    CVnCoV                  CureVac   Germany and Belgium RNA 168   18–60 years
    Covax-19                Vaxine Australia      Protein 40 18–65 years
    Unnamed                   People’s Liberation Army, Academy of Military Sciences China  RNA 168 18–80 years
    SARS-CoV-2 S clamp                 University of Queensland   Australia  Protein  216 ≥18 years
    CoVLP                Medicago  Canada Virus like particle  180  18–55 years
    BNT162 BioNTech China RNA platform 144 ≥18 years
    V591 Institute Pasteur France and Belgium Viral vector 90 18–55 years
    GRAd-COV2 ReiThera Italy Viral vector 90 18–55 years and 65-85 years
    UB-612 United Biomedical Taiwan Protein 60 20–55 years
    VXA-CoV2-1 Vaxart USA Viral vector 48 18–54 years
    Ad5-nCoV Institute of Biotechnology, Academy of Military Medical Sciences China  Viral vector 144 ≥18 years
    Unnamed West China Hospital China Protein   168 ≥18 years
    MVC-COV1901 Medigen Vaccine Biologics Taiwan Protein    45 20–50 years
    hAD5-S-Fusion+N-ETSD ImmunityBio USA Viral vector 35 18–55 years
    bacTRL-Spike Symvivo     Australia DNA 12 ≥18 years
    COH04S1 City of Hope Medical Center USA Viral vector 129 18–55 years 
    Unnamed Jiangsu Province Centres for Disease Control and Prevention China Protein 216 ≥18 years
    FINLAY-FR-2 Finlay Vaccine Institute Cuba Protein    40 19–59 years
  • COVID-19 vaccines in clinical trials in Australia

    There are currently six COVID-19 vaccines in human clinical trials in Australia. Two candidates, Covax-2019 (Vaxine) and SARS-CoV-2 S clamp (University of Queensland), are being developed and trialled in Australia. 

    The other four candidates are being developed in countries outside of Australia: the SCB-2019 candidate by Clover Biopharmaceuticals is developed in China, the NVX-CoV2373 candidate by Novavax is developed in the United States, the RBD-SARS-CoV-2 HBsAg VLP vaccine by SpyBiotech is developed in the United Kingdom (and has a partnership with the Serum institute of India) and the bacTRL-Spike vaccine by Symvivo is developed in Canada.

    Novavax published phase 1 results in the New England Journal of Medicine on 2 September 2020. 

    At the end of September, the Australian Government pledged almost $6 million in additional funding from the Medical Research Future Fund’s (MRFF) Coronavirus Research Response to support research and development of three Australian COVID-19 vaccines. For further information on COVID-19 vaccine development in Australia, click here and for further information on the phase I/Ib human trial, click here.
     

    map

     

    * To see the 10 locations in Australia for Novavax's phase II trial, see the trial register. 

    • COVID-19 vaccine development in Australia

      Several COVID-19 candidate vaccines are being developed in Australia. Two candidates have entered into phase I clinical trials and others are currently in laboratory and pre-clinical stages. The following information is from publicly available data and may not include all candidates in development in Australia. 

      Phase 1 trial
      Vaccine Developer Platform Collaborators Manufacturing capacity Trial
      Covax-19 Vaxine Recombinant spike protein with Advax® adjuvant Medytox, South Korea (biopharmaceutical) and Oracle Cloud technology (technical collaboration) Not yet published Commenced phase I trial on 30 June 2020 in Adelaide
      SARS-CoV-2 S clamp The University of Queensland Protein subunit with the MF59 adjuvant CSIRO (pre-clinical testing) and Coalition of Epidemic Preparedness and Innovations, CEPI (funding) CSL (100 million doses) Commenced phase I trial on 14 July 2020 in Brisbane
       
       
       
       
       
      Lab and preclinical
      Organisation Platform Collaborator
      Griffith Institute for Drug Discovery GRIDD, Queensland Virus-like particle Lunia Bio (biomanufacturing)
      Griffith University, Queensland Live attenuated Indian Immunologicals Limited (manufacturing)
      Doherty Institute, Victoria           Virus like particle Not yet published 
      Monash University, Melbourne mRNA (3 candidates) Not yet published 
      University of South Australia, South Australia Non replicating viral vector using Sementis-Copenhagen vector (SCV) platform technology Sementis Ltd
    • COVID-19 vaccine introduction and program planning in Australia
      Therapeutic Goods Administration

      The Therapeutic Goods Administration (TGA) has given provisional determination to three vaccine candidates: 

       

      This means that these companies are now eligible to apply for provisional registration of their vaccine in the Australian Register of Therapeutic Goods (ARTG). However, these companies have not yet made any application to be registered for use in the ARTG. 

      Provisional determination is the first step, before provisional registration.

      Commonwealth Government COVID-19 Vaccine Taskforce

      The COVID-19 Vaccine Taskforce is working with the Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 Working Group, the TGA as well as local and international vaccine manufacturers for access to and delivery of safe and effective COVID-19 vaccines for all Australians. 

      COVID-19 vaccines will and must be evaluated for safety and effectiveness before they are registered for use in Australia. Strategic planning on the COVID-19 vaccine program implementation, safety monitoring and communication is underway. 

      COVID-19 vaccines and treatments

      There is currently no specific treatment or approved vaccine that cures or prevents COVID-19. Researchers and companies across the world are developing potential vaccines and treatments, and the Australian Government has a strategy to deliver them to Australians.

      Read about vaccines and treatments here

      Read about the strategy here

      Australia’s vaccine agreements

      Australia has entered into five separate agreements for the supply of COVID-19 vaccines, if they are proved to be safe and effective.

      Read about these agreements here

      Find out more about each of these vaccines for COVID-19 and the COVAX Facility by clicking on the links below:

      The University of Oxford vaccine 

      The University of Queensland vaccine 

      The Novavax vaccine 

      The Pfizer/BioNTech vaccine 

      The COVAX Facility

    Vaccines must go through several phases of clinical trials before they can enter the market. Not all vaccines that enter the initial phases of clinical trials make it to the market. Visit our Phases of clinical trials page to learn more.

    Different platforms are used to develop viral vaccines. Each of these platforms has its own advantages and disadvantages. Visit our Vaccine platforms page to learn more.

    Note: NCIRS checks clinical trial registries, particularly the U.S. National Institutes of Health, National Library of Medicine: Clinical Trials Gov, EU Clinical Trials Register, ISRCTN, Cochrane COVID-19 Study Register, Clinical Trials Registry – India,  Australian New Zealand Clinical Trials Registry, Chinese Clinical Trial Registry on a regular basis to monitor the commencement of clinical trials.