COVID-19

• 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.