COVID-19 vaccine development landscape

COVID-19

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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. 

Global snapshot - 02 March 2023. 199 vaccines in pre-clinical development 180 vaccine candidates in human clinical trials 50 vaccine candidates in phase III clinical trials 11 vaccine candidates in phase IV post-licensure surveillance

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
    BBV152/Covaxin Bharat Biotech International Inactivated 2 doses, 28 days apart   TGA recognised vaccine
    Gam-COVID-Vac Gamaleya Research Institute Viral vector 1 dose of Ad26 prime-boost and at day 21 Ad5 COVAX facility TGA recognised vaccine
    COVAX-19 (with Advax-SM adjuvant) Vaxine Pty Ltd/Cinnagen Protein 2 doses, 21 days apart   TGA provisional determination 
    Unnamed Wuhan Institute of Biological Products Inactivated 2 doses, 21 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

    (Vidprevtyn) 

    		 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

    (Turkovac) 

    		 Erciyes University Turkey Inactivated  2 doses, 21 days apart    
    SCB-2019  Clover Biopharmaceuticals and CEPI Protein 2 doses, 21 days apart COVAX once approved by WHO  
    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    
    COVI-VAC Codagenix / Serum Institute of India Live attenuated virus 1 or 2 doses, 28 days apart    
    INO-4800 [with electroporation] Inovio Pharmaceuticals / Advaccine Biopharmaceuticals DNA 2 doses, 28 days apart COVAX facility  
    DelNS1-2019-nCoV-RBD-OPT [intranasal spray] Wantai Biological Pharmacy / University of Hong Kong / Xiamen University Viral vector (replicating) 2 doses, 28 days apart    
    V-01 Livzon Pharmaceutical Group Protein 2 doses, 21 days apart    
    RBD protein recombinant SARS-CoV-2 (Noora vaccine) Bagheiat-allah University of Medical Sciences Protein 3 doses, 21 then 14 days apart    
    S-268019 Shinogi Protein 2 doses, 21 days apart    
    BBV154 (intranasal) Bharat Biotech Viral vector (non-replicating) 1 dose    
    PHH-1V Laboratorios Hipra Scientific Protein 2 doses, 21 days apart    
    SCTV01E Sinocelltech Ltd. Protein 3 doses on D0, D28, D180
    Or
    2 doses, 180 days apart    		    
    S-268019-b Shionogi Inc. Protein 2 doses, 21 days apart    
    ABNCoV2 Radboud University Virus-like particle 2 doses, 28 days apart    
    Recombinant two-component COVID-19 vaccine (CHO cell) [NTD-RBD-foldon protein] Jiangsu Rec-Biotechnology Co Protein subunit 3 doses, 21 days apart    
    Omicron-BBIBP-CorV China National Biotec Group Company Limited & Beijing Institute of Biological Products Co Ltd Inactivated 1 or 2 booster doses; either 3-6, 6-12 or >12 months after primary course    
    CoviVac Chumakov Federal Scientific Center for Research and Development of Immune and Biological Products Inactivated 2 doses, 21 days apart    
    KD-414 KM Biologics Co Ltd Inactivated 2 doses, 28 days apart    
    Unnamed (adjuvanted with Alum + CpG 1018 PT Bio Farma Protein subunit 2 doses, 28 days apart    
    LVRNA009 AIM Vaccine Co., Ltd. & Liverna Therapeutics mRNA 2 doses, 28 days apart    
    Ad5-nCoV/O & Ad5-nCoV/O-IH (Bivalent ancestral/ Omciron) CanSino Biologics Viral vector (bivalent) 1 dose (booster)    
    mRNA-1273.214 (Bivalent ancestral/ Omciron) Moderna mRNA (bivalent) 2 doses, 28 days apart 
    OR
    1 dose (booster)
         		   TGA provisional approval (booster dose in ≥18 years) 
    UNAIR inactivated COVID-19 vaccine
       
         		 Airlangga University Indonesia  Inactivated    2 doses, 28 days apart    
    PTX-COVID19-B
            
         		 Everest Medicines & Providence Therapeutics mRNA 2 doses, 28 days apart    
    UB-612 Vaxxinity, Inc. Protein subunit    2 doses, 28 days apart   TGA provisional determination 
     
    EuCorVac-19
        
         		 EuBiologics Co Ltd   Protein subunit  2 doses, 21 days apart    
    SW-BIC-213
        
         		 Stemirna Therapeutics  mRNA   Booster dose    
    Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) National Vaccine and Serum Institute, China Protein subunit 1 dose booster, ≥6 months after primary course    

    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)

    TGA provisional approval (5 to 11 years) 

    TGA provisional approval (6 months to 4 years) 

    TGA provisional approval booster dose (≥5 years) 

    TGA provisional determination for Omicron-targeted vaccines

    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)

    TGA provisional approval booster dose (≥18 years) 
    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)

    TGA provisional approval (6 to 11 years) 

    TGA provisional approval booster dose (≥12 years) 

    TGA provisional approval for SPIKEVAX Bivalent Original/Omicron (booster dose in ≥18 years)

    TGA provisional approval (6 months to 5 years)

    TGA provisional determination for SPIKEVAX Bivalent Original/Omicron BA.4/BA.5 (booster dose in ≥18 years)

    NVX-CoV2373

    (Nuvaxovid, Covovax) 

    		 Novavax Protein 2 doses, 21 days apart

    Australia during 2021: 51 million doses available

    COVAX facility

    TGA provisional approval (≥18 years) and TGA provisional approval (12 to 17 years) 

    TGA provisional approval booster dose (≥18 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  TGA recognised vaccine
    BBIBP-CorV/Covilo Sinopharm / Beijing Institute of Biological Products Inactivated 2 doses,
    21 days apart    		 COVAX facility

    TGA recognised vaccine

    TGA removes age limit for vaccine recognition 
    MVC-COV190 Medigen Vaccine Biologics Protein subunit   2 doses, 28 days apart   TGA provisional determination 

    Ad5-nCoV

    (Convidecia or PakVac)

    		 CanSino Biologics Viral vector 1 dose    
    Ad5-nCoV-IH
    (Convidecia aerosolised and inhaled through mouth)    		 CanSino Biologics Viral vector 1 dose    
    WIBP-CorV (COVAX Produced in Wuhan) Sinopharm / Wuhan Institute of Biological Products Inactivated virus 2 doses, 21 days apart    

    Notes:

    * The following COVID-19 vaccines have been granted an Emergency Use Listing (EUL) by the World Health Organization (WHO): BNT162b2 (COMIRNATY), ChAdOx1 (VAXZEVRIA and COVISHIELD), Ad26.COV2.S (JANSSEN COVID-19 VACCINE), mRNA-1273 (SPIKEVAX), BBIBP-CorV (COVILO SINOPHARM), CoronaVac, BBV152 (COVAXIN), NVX-CoV2373 (NUVAXOVID and COVOVAX), Ad5-nCOV (CONVIDECIA)

    † COVID-19 vaccines undergo a prequalification (PQ) evaluation process before they are granted EUL by WHO. The status of COVID-19 vaccines within the WHO EUL/PQ evaluation process can be found here.
     

  • COVID-19 vaccine development in Australia

    There are currently 17 COVID-19 vaccines in human clinical trials in Australia. Four vaccines are being developed and trialled in Australia. The other 13 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)
    II-III
    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 / ChulaCov19 BNA159 BioNet-Asia (Thailand) and Technovalia (Australia) DNA (needle-free) I Sydney, Perth and Adelaide NCT04742842  
    II Canberra, Sydney and Brisbane NCT05605470  
    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  
    DoCo-Pro-RBD-1 + MF59 University of Melbourne (Australia) / 
    Southern Star Research (Australia)
         		 Adjuvanted beta variant RBD recombinant protein I Melbourne     NCT05272605  
    MIPSCo-mRNA-RBD-1 University of Melbourne (Australia) / 
    Southern Star Research (Australia)
     

    mRNA (beta variant)

    		 I Melbourne     NCT05272605  
    BNT162b2 & mRNA-1273 (fractional doses)             NCT05228730 Murdoch Children's Research Institute & CEPI   mRNA  III    Victoria NCT05228730  
    ‘PICOBOO’: BNT162b2 or mRNA-1273 booster following 2 doses of BNT162b2 or ChAdOx primary                
         		 Telethon Kids Institute  mRNA III Perth, Adelaide & Launceston ACTRN12622000238774  
    EG-COVID-003 or 
    EG-COVID-001                
         		 EyeGene Inc. (South Korea) / 
    Novotech (Australia) Pty Ltd    		 mRNA I/II  Sydney  NCT05188469  
    IN002.5.1 (in comparison with approved mRNA) Shenzhen Shenxin Biotechnology Co., Ltd. (China) mRNA I New Zealand and Australia ACTRN12622001415796p  

    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
    University of Queensland Viral vector (1 x replication), intranasal administration (nasal spray) Nucleus Network
    Sydney Institute for Infectious Diseases, The University of Sydney, New South Wales Protein subunit Coalition for Epidemic Preparedness Innovations (CEPI),
    Bharat Biotech International,
    ExcellGene SA,
    Centenary Institute (Australia)
  • COVID-19 vaccine introduction and program planning in Australia
    Therapeutic Goods Administration

    The Therapeutic Goods Administration (TGA) is responsible for assessing all COVID-19 vaccines before they can be used in Australia. The granting of a provisional determination means that the TGA has made a decision that relevant sponsors are now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). Once approved by the TGA, the vaccine is included in the ARTG as a provisionally registered medicine and is able to be lawfully supplied in Australia by the sponsor. Further information on the TGA’s COVID-19 vaccine approval process can be found here. 

    The following COVID-19 vaccines have received provisional approval from the TGA and are included in the ARTG as a provisionally registered medicine:

    • VAXZEVRIA (previously COVID-19 Vaccine AstraZeneca) developed by AstraZeneca and the University of Oxford
    • COMIRNATY (tozinameran) developed by Pfizer-BioNTech
    • SPIKEVAX (elasomeran) developed by Moderna
    • NUVAXOVID (NVX-CoV2373) developed by Novavax
    • COVID-19 Vaccine Janssen developed by Janssen/Johnson and Johnson (approved but not in use in Australia)
    • SPIKEVAX Bivalent Original/Omicron developed by Moderna
    • COMIRNATY Original/Omicron BA.1 (tozinameran and riltozinameran) developed by Pfizer-BioNTech
    • COMIRNATY Original/Omicron BA.4-5 (tozinameran & famtozinameran) developed by Pfizer-BioNTech
    • SPIKEVAX Bivalent Original/Omicron BA.4-5 (elasomeran and davesomeran) developed by Moderna

     

    The following COVID-19 vaccines have received provisional determination from the TGA, and are currently under review:

    • Riltozinameran (COMIRNATY OMICRON)
    • Elasomeran and Davesomeran (SPIKEVAX BIVALENT ORIGINAL-OMICRON BA.4-BA.5)
    • MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine)
    • Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2 (known as COVAX-19 and SpikoGen overseas)
    • UB-612 COVID-19 Vaccine

     

    Bivalent COVID-19 vaccines in Australia

    The TGA has granted provisional approval, or is currently evaluating, the following bivalent vaccines for use in Australia:


    The TGA recognises some COVID-19 vaccines that are used in other countries, but not approved for use in Australia. Please find further information on COVID-19 vaccines recognised in Australia for incoming travellers here. 

    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.

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