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 will be updating this page fortnightly. 

14 Apr

 

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
    Ad26.CoV2.S Janssen Viral vector 1 dose or 2 doses, 56 days apart   TGA provisional determination*
    NVX-CoV2373 Novavax Protein 2 doses, 21 days apart

    Australia during 2021: 51 million doses available

    COVAX facility

    TGA provisional determination
    BBIBP-CorV Sinopharm / Beijing Institute of Biological Products Inactivated 2 doses, 21 days apart    
    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  
    Ad5-nCoV CanSino Biologics Viral vector 1 dose    
    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
       

    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 (Comirnaty) BioNTech/Pfizer     mRNA 2 doses,
    21 days apart

    Australia: 20 million doses secured for 2021

    COVAX facility: 40 million doses

    TGA provisional approval
    ChAdOx1 nCoV-19/AZD1222 (COVID-19 Vaccine AstraZeneca) 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
    CoronaVac Sinovac Biotech     Inactivated 2 doses, 14 days apart    
    mRNA-1273
     
    Moderna mRNA 2 doses, 28 days apart COVAX facility  

     

  • COVID-19 vaccine development in Australia

    There are currently six COVID-19 vaccines in human clinical trials in Australia. Only one vaccine, Covax-19 (Vaxine), is being developed and trialled in 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.

    The other five candidates are being developed in countries outside of Australia.

    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*
    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  

    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
    • COVID-19 vaccine introduction and program planning in Australia
      Therapeutic Goods Administration

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

      Now these companies are eligible to apply for provisional registration of their vaccine in the Australian Register of Therapeutic Goods (ARTG).

      On 25 January 2021, the TGA granted provisional approval of BioNTech/Pfizer’s COVID-19 vaccine BNT162b2 (Comirnaty).

      On 16 February 2021, the TGA granted provisional approval of University of Oxford/AstraZeneca’s COVID-19 vaccine ChAdOx1 nCoV-19/AZD1222 (ChAdOx1-S).

      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.