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. For the most up to date information on COVAX, click here. We update this page fortnightly. 

Global snapshot 13 Oct

Figures are based on the WHO document Draft landscape of COVID-19 candidate vaccines and monitoring of clinical trials registries.

  • COVID-19 vaccines in phase III 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 phase III clinical trials only. For a full list of COVID-19 candidates in clinical trials, check out the WHO Draft landscape of COVID-19 candidate vaccines and the London School of Hygiene and Tropical Medicine COVID-19 vaccine tracker.

    Click here to find out which vaccines are already in use in other countries.

    Vaccine Developer/Manufacturer Vaccine platform Number of doses, schedule Agreement (Australia/COVAX) Regulatory approval status in Australia
    NVX-CoV2373 Novavax Protein 2 doses, 21 days apart

    Australia during 2021: 51 million doses available

    COVAX facility

    TGA provisional determination*
    Unnamed Wuhan Institute of Biological Products Inactivated 2 doses, 21 days apart    
    Gam-COVID-Vac Gamaleya Research Institute  Viral vector 1 dose of Ad26 prime-boost and at day 21 Ad5 COVAX facility  
    BBV152/Covaxin Bharat Biotech International Inactivated         2 doses, 28 days apart    
    ZF2001 Anhui Zhifei Longcom Protein 3 doses, 0, 1 and 2 months    
    CoVLP Medicago Virus like particle 2 doses, 21 days apart    
    CVnCoV CureVac mRNA 2 doses, 28 days apart        
    QazCovid-in-vaccine Research Institute for Biological Safety Problems Inactivated 2 doses, 21 days apart    
    ZyCoV-D Zydus Cadila Health Care DNA 3 doses, 28 days apart    
    Unnamed Chinese Academy of Medical Sciences / Institute of Medical Biology Inactivated 2 doses,
    14 days apart    
       
    VAT00002 Sanofi Pasteur/GSK     Protein 2 doses, 21 days apart COVAX facility  
    FINLAY-FR-2 Instituto Finlay de Vacunas Protein
    2 doses,
    28 days apart    
       
    EpiVacCorona Federal Budgetary Research Institution State Research Centre of Virology and Biotechnology ‘Vector’ Protein 2 doses,
    21 days apart
       
    CIGB-66 / Abdala Center for Genetic Engineering and Biotechnology Protein 3 doses,
    14 days apart or 28 days apart
       
    Unnamed Beijing Minhai Biotechnology / Shenzhen Kangtai Biological Products Inactivated 2 doses,
    28 days apart
       
    ARCoV Walvax Biotechnology / Academy of Military Science (AMS) / Suzhou Abogen Biosciences mRNA 2 doses,
    14 days apart or 28 days apart
       
    VLA2001 Valneva/National Institute for Health Research United Kingdom Inactivated  2 doses, 21 days apart    
    RBD recombinant (Sf9 cell) West China Hospital / Sichuan University Protein
    2 doses, 28 days apart
       
    Nanocovax Nanogen Pharmaceutical Biotechnology Protein 2 doses, 21 days apart    
    ERUCOV-VAC Erciyes University Turkey Inactivated  2 doses, 21 days apart    
    COVAX-19 (with Advax-SM adjuvant) Vaxine Pty Ltd/Cinnagen Protein 2 doses, 21 days apart    
    SCB-2019  Clover Biopharmaceuticals and CEPI Protein 2 doses, 21 days apart COVAX once approved by WHO  
    MVC-COV1901 Medigen Vaccine Biologics  Protein 2 doses, 28 days apart    
    GBP510 SK Bioscience Co. and CEPI Protein 2 doses, 28 days apart COVAX once approved by WHO  
    Fakhravac / Razi Cov Pars Razi Vaccine and Serum Research Institute Protein 2 doses, 21 days apart    
    BECOV2 Biological E. Limited and CEPI Protein 2 doses, 28 days apart COVAX once approved by WHO  
    ARCT-154 Arcturus Therapies Inc saRNA 2 doses, 28 days apart    

    Notes:

    When the Therapeutic Goods Administration (TGA) grants provisional determination, candidates are eligible to apply for provisional registration of their vaccine in the Australian Register of Therapeutic Goods (ARTG).

  • COVID-19 vaccines in phase IV post-licensure surveillance globally

    Phase IV studies and surveillance are conducted after a vaccine is licensed and available to the public. During this time, information on vaccine effectiveness in the general population and safety monitoring of any adverse events are collected and analysed. 

    Below are candidate vaccines that are currently in phase IV post-licensure surveillance globally.
     

    Vaccine Developer/Manufacturer Vaccine platform Number of doses, schedule Agreement (Australia/COVAX) Regulatory approval status in Australia
    BNT162b2/Tozinameran
    (Comirnaty)
    BioNTech/Pfizer mRNA 2 doses,
    21 days apart

    Australia: 20 million doses secured for 2021

    COVAX facility: 40 million doses

    TGA provisional approval (16 years and older)

    TGA provisional approval (12 to 15 years)

    ChAdOx1 nCoV-19/AZD1222 (Vaxzevria)

    *also known as Covishield when manufactured by Serum Institute of India

    University of Oxford Viral vector 2 doses,
    12 weeks apart

    Australia: secured 53.8 million doses 
    From early 2021: 3.8 million doses delivered to Australia

    COVAX facility

    TGA provisional approval (18 years and older)
    mRNA-1273/Elasomeran
    (Spikevax)
     
    Moderna mRNA 2 doses, 28 days apart

    Supply agreement for 25 million doses
    Australia during 2021:
    10 million doses mRNA-1273
    Australia during 2022:
    15 million doses mRNA-1273.351 or mRNA-1273.211

    COVAX facility

    TGA provisional approval (18 years and older)

    TGA provisional approval (12 to 17 years)

    Ad26.COV2.S Janssen (Johnson & Johnson) Viral vector  1 dose COVAX facility TGA provisional approval
    CoronaVac Sinovac Biotech Inactivated 2 doses, 14 days apart COVAX facility   
    BBIBP-CorV/Covilo Sinopharm / Beijing Institute of Biological Products Inactivated 2 doses,
    21 days apart
    COVAX facility  

    Ad5-nCoV

    (Convidecia or PakVac)

    CanSino Biologics Viral vector 1 dose    

     

  • COVID-19 vaccine development in Australia

    There are currently 12 COVID-19 vaccines in human clinical trials in Australia. Two vaccines, Covax-19 (Vaxine) and EDV-plasmid-spike-GC (EnGeneIC), are being developed and trialled in Australia. The other 10 candidates are being developed in countries outside of Australia.

    Previously, the University of Queensland’s vaccine, v451, was in phase I clinical trials, but it did not progress into further trials because the clamp protein (being derived from the HIV virus) has the potential to interfere with some HIV screening tests and can lead to a false positive test result in vaccine recipients.

     

    Current COVID-19 vaccine trials

    Vaccine Developer Platform Phase Location Clinical trials register Published results
    SCB-2019 Clover Biopharmaceuticals (China) Protein I Perth NCT04405908

    Phase 1

    (The Lancet)

    NVX-CoV2373 Novavax (USA) Protein I Melbourne and Brisbane NCT04368988 Phase 1
    II 10 locations*
    ICC (combination vaccine of NVX-CoV2373 and qNIV Novavax (USA) Adjuvanted combination I/II Queensland NCT04961541  
    Covax-19 Vaxine (Australia) Protein I Adelaide NCT04453852  
    RBD-SARS-CoV-2 HBsAg VLP Spy Biotech (UK) VLP I/II Melbourne ACTRN12620000817943  
    bacTRL-Spike Symvivo (Canada) DNA (oral) I Melbourne NCT04334980  
    COVIGEN BioNet-Asia (Thailand) and Technovalia (Australia) DNA (needle-free) I Sydney, Perth and Adelaide NCT04742842  
    SC-Ad6-1 Tetherex Pharmaceuticals Corporation (USA) Viral vector (non-replicating) I Brisbane NCT04839042  
    VAW00001 Sanofi Pasteur (France) mRNA        I/II     Qld, Vic, WA & International  NCT04798027  
    EDV-plasmid-spike-GC EnGeneIC (Australia) EDVTM nanocells packaged with spike protein I Melbourne     ACTRN12621001159842  
    IN-006 Nucleus Network (USA) Inhaled antibody I Melbourne     ACTRN12621001235897  
    IVX-411 Icosavax and University of Washington (USA) VLP I/II  Queensland    ACTRN12621000882820  

    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

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

    Laboratory and pre-clinical vaccine trials

    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
    Nucleus Network Viral vector (1 x replication), intranasal administration (nasal spray) University of Queensland
  • COVID-19 vaccine introduction and program planning in Australia
    Therapeutic Goods Administration

    The Therapeutic Goods Administration (TGA) has given (as at 9 August 2021) provisional approval to Moderna's COVID-19 vaccine Spikevax (elasomeran). Spikevax has become the fourth COVID-19 vaccine to be given provisional approval by the TGA. 

    BioNTech/Pfizer’s COVID-19 vaccine BNT162b2 (Comirnaty) and University of Oxford/AstraZeneca’s COVID-19 vaccine ChAdOx1 nCoV-19/AZD1222 (ChAdOx1-S) have already been registered  and are in use in Australia. The TGA has also given provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) COVID-19 vaccine Janssen, but this vaccine is not in use in Australia.

    The TGA has given provisional determination to Novavax’s candidate NVX-CoV2373. This means Novavax is eligible to apply for provisional registration of their vaccine in the Australian Register of Therapeutic Goods (ARTG).

    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. 

    Access our COVID-19 vaccination program in Australia page here

    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

    Australia’s epidemiology and COVID-19 vaccine roadmap

    Read the strategy here 

    COVID-19 vaccines: Frequently asked questions

    Visit our COVID-19 vaccines: Frequently asked questions page to find answers to some commonly asked questions about COVID-19 vaccines.

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.