COVAX-19 FAQ

Who is Vaxine?

Vaxine was incorporated in 2002 as an Australian biotechnology company focusing on development of innovative vaccine technologies, with its lead product being its Advax delta inulin adjuvant.

Supported by funding contracts from the National Institutes of Health, Vaxine has developed a broad range of vaccines, all utilizing its Advax adjuvant technology for enhanced immunogenicity and protection. Vaxine’s human candidates include vaccines against seasonal and pandemic influenza, COVID-19, hepatitis B, Japanese encephalitis, West Nile Virus, malaria, rabies, and allergy. Vaxine also has a veterinary division that is commercialising vaccine adjuvants tailored to specific animal health problems.

Vaxine has developed a recombinant protein-based vaccine against COVID-19 which is currently in advanced clinical development and it is hoped this vaccine will achieve emergency use approval in 2022.

You can read more about Vaxine’s projects here.

About the Covax-19 vaccine

How does the Covax-19 vaccine work?

COVAX-19 vaccine is designed to protect against SARS-CoV-2 infection by generation of neutralising antibodies and cellular responses against the virus.

Most recently, a pivotal Phase 3 trial in Iran involving 16,876 participants demonstrated robust protection against the notorious Delta variant.

With these results, in early October 2021 it received market authorisation for emergency use from the Iranian FDA. Already over 2 million doses have been safely distributed by Iranian immunisation centres.

Notably, the Phase 2 trial showed induction of neutralising antibodies against all the major variants of concern indicating very broad cross-protection. In support of this, it provided strong protection against a range of virus variants (Wuhan, Beta, Delta) in animal challenge models, with studies in hamsters, ferrets and monkeys. Notably, it was shown to block SARS-CoV-2 virus shedding from the nose and thereby prevented transmission from challenged to naive animals, a unique finding.

On the safety side, it has been extremely well tolerated with no vaccine-associated serious adverse reactions seen in the clinical trials or in post-market pharmaco-vigilance. Notably, there have been no cases reported of myocarditis/pericarditis, arrythmias or sudden death, or central venous thrombosis.

Are Covax-19 and Novavax the same?

COVAX-19 differs from its USA competitor NOVAVAX in a number of ways.  COVAX-19 is an Australian developed vaccine by an Australian physician and scientist, Prof. Nikolai Petrovsky and his Team at Vaxine Pty Ltd.  Novavax is a US based company who use the full length protein spike whereas COVAX-19 uses a trimmed down protein.  We also use an adjuvant which is like a “turbo-charger” for vaccines which is made from Inulin, a plant fructose.

What is the difference between COVAX-19 and the mRNA vaccines that are currently available in Australia? 

Covax-19 is a protein based vaccine.  Protein based vaccines have been around for over 50 years and have had extensive longitudinal studies conducted on them over that period of time.   We know that a protein based vaccine is well tolerated with few side effects.

mRNA vaccines are gene therapies that have only recently been administered to humans, the mRNA.  In this video Rob Malone, the inventor of mRNA explains the mRNA vaccine.

https://vimeo.com/648749188/5333c4b078

COVAX-19 Australian Clinical Trial

Status & Timeline 

Current Status

Vaxine Pty Ltd has completed Phase 1 in Australia and Phases 2 and 3 in the Middle East.  The vaccine now has approval by the FDA in Iran.   We will now be conducting a community based Phase 3b study to assess the effect of varying the time interval between doses on the immunogenicity of recombinant spike protein Covid-19 vaccine (COVAX-19/Spikogen)  (COVAX19-P3b).  We have submitted the Ethics Application to the Ethics Committee and we are awaiting approval.

Timeline

Participants registering interest in trial – ongoing.

Ethics approval –expected late January-early February.

Invitation to participate in trial – within 4-8 weeks of approval from Ethics Committee (please see below for limitations on selection for the trial).

TGA Approval

On 20 December 2021, the TGA granted provisional determination to Vaxine Pty Ltd in relation to its COVID-19 vaccine: Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2 (active ingredient name and tradename to be confirmed).

This recombinant protein vaccine will be considered for active immunisation to prevent COVID-19 caused by SARS-CoV-2. If approved, a complete course of the Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2 vaccine is potentially two doses given as an intramuscular injection 3 weeks apart.

The granting of a provisional determination means that the TGA has made a decision that Vaxine Pty Ltd is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the provisional registration process.

It may take up to six months to receive a final decision.  See further explanation as to the TGA process further below. 

Registration

How do I register for this trial?

To register for this trial, please visit the Vaxine website or click here.

Is there a closing date for registration?

Not at this stage. Once registrations close, it will be stated on the Vaxine website.

Registration Submission and subsequent acknowledgment letters

Once you have registered, you will receive an acknowledgment of registration letter.

What will the primary goal of the clinical trial be?

This community-based trial will be looking at the effect of varying the time interval between doses on the immunogenicity of the Covid-19 vaccine.

Which states can participate in this trial?  

Our plan is to set up clinical trial sites in each State depending on resources and identification of trial sites in each State. 

Will every person registered for the clinical trial be accepted to participate?  

We will endeavour to accommodate as many people as possible – but not everyone will be able to be in the trial both because of the limited resources and eligibility status.

Inclusion/Exclusion Criteria

  • Pregnant women and anyone under the age of 18 are currently excluded. Breastfeeding women may be included.
  • There is no upper age limit.
  • Previous COVID-19 infection is not an exclusion.
  • Participants must be vaccine naïve for this trial. This means that you must not have had another TGA approved vaccine. We are planning a booster trial in the future and this will not exclude participants who have had current TGA approved vaccines.
  • Previous infection does not exclude you from the trial.
  • Other criteria may apply. Initial participants will be on a first come, first serve basis of application.

COVAX-19 Australian Clinical Trial specifics

What will be the primary goal of this clinical trial?  

We are going to be looking at different intervals between the first and second dose.

Every approved participant will receive the COVAX-19 vaccine on day 1 of trial. Depending on the group you are randomised to, the 2nd dose will be given at either Week 3, 4,5 and 6. This cannot be chosen by participant as it is a blind randomised process.  You will be followed up for a period of 6 months post the 2nd dose of your vaccine.

Can I transfer my offer to participate in the trial?

If accepted into the trial, this position cannot be transferred to other members of family or friends. You can pull out of this trial at any time. Whilst this trial is considered a full course of COVID-19 vaccine, booster shots may be required in the future. 

Will there be a placebo?

No, every participant will get an active vaccine.

When will this trial commence?  

The trial will commence within 4 weeks of receiving approval.

How many people will be included in the trial?

At this stage it will depend on resources as to how many people we can enrol in the trial. We currently have over 29,000 Registrations Australia wide.

Will we be considered ‘vaccinated’ by the Australian Government whilst on this trial?

You will need to speak with the Health Department in your State and ask if as a trial participant receiving a COVID-19 vaccine you will be considered vaccinated.

Is this clinical trial considered a full course of Covid-19 vaccine?

Yes, but like other vaccines, boosters may be required in the future.

Medical Exemptions 

Health departments in every state do not acknowledge registration in this trial as being medically exempt from COVID-19 vaccination. You should check with your Health Department as to the status of a trial participant who is vaccinated with COVAX-19.  Just to be clear, the team at Vaxine have no influence over the Health Departments’ decisions and we do recommend that you contact them directly, as we cannot help you navigate this.  We will be in contact with you with regards approval to participate in the trial once we have received Ethics Approval.

GoFundMe Fundraiser 

What are the GoFundMe Page funds being used for?

Initially we were raising money to pay for the TGA fees, which are up to $300,000.  The additional funds will be used to fund the trial.

How can you help?

Please share our GoFundMe https://www.gofundme.com/f/bringing-covax19-back-to-australia with your network so we can raise additional much needed funds for the clinical trial.  You can write to your local members of parliament and encourage them to support Vaxine Pty Ltd and COVAX-19 and ask them to indemnify the Clinical Trial in their State.

 GoFundMe fundraiser:https://www.gofundme.com/f/bringing-covax19-back-to-australia 

What are the GoFundMe Page funds being used for?

  • Ethics application for the Clinical Trial – $6025.00.
  • Running of trial. Approximate costs normally a clinical trial will cost between $5000-$10,000 per subject.
  • TGA approval process – $300,000 for fees and we still have to engage a regulatory consultant (additional cost). 

TGA Approval process and Australian regulatory approval

Is approval of the COVAX-19 for use in Australia dependent on the clinical Trial?  

No. 

What is the TGA approval process and timeline for regulatory approval in Australia?

Stage 1

In order to submit an application under the provisional pathway, a Vaxine must first submit a provisional determination application.

The TGA will assess the application against specific eligibility criteria, such as the nature of preliminary clinical data, evidence of a plan to submit comprehensive clinical data, and the clinical need.

If the TGA grants provisional determination, the sponsor is then eligible to apply for provisional registration of the vaccine in the Australian Register of Therapeutic Goods (ARTG).

Importantly, granting provisional determination does not mean that the sponsor will submit an application, or that the TGA will approve the subsequent application.

Stage 2

Once provisional determination has been granted, the sponsor then needs to submit an application for provisional registration.

To register a COVID-19 vaccine in Australia, Vaxine is required to submit a comprehensive dossier that includes specific information on clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management and other information.

The TGA may agree upfront to accept a limited number of rolling submissions of data during the evaluation phases, as well as reports from comparable overseas regulators.

The TGA will make a preliminary assessment whether to accept the submission for evaluation and will notify the sponsor.

Stage 3

Once an application is accepted, the TGA will commence a formal evaluation process that is carried out in multiple phases by technical experts.

This process involves obtaining further information and clarification from Vaxine, as well as being informed by the advice of the Advisory Committee on Vaccines, an independent committee of external experts.

Stage 4

Once the evaluation is complete, the TGA delegate will make a decision whether to provisionally register the vaccine in the ARTG. The decision to approve a new vaccine is always made by the TGA on the basis that the benefits outweigh the risks.

The TGA delegate’s decision to grant provisional registration is based on a number of factors including:

  • the safety, quality and effectiveness of the vaccine has been satisfactorily established for its intended use
  • the sponsor’s plan to submit comprehensive clinical data, stability data and other information before the provisional registration ends

Stage 5

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 Vaxine.

Approved vaccines will appear in the searchable ARTG on the TGA website. Product Information and Consumer Medicines Information will also be available in the MedSearch App in the same way as for any other registered medicine.

The provisional registration is for an initial period of two years, with the option to apply for up to two extensions, up to a maximum of six years.

Stage 6

The TGA will continue to play an active role in the ongoing monitoring of any vaccines available in Australia, and has robust procedures in place to investigate any potential new safety issues.

The TGA’s vaccine safety monitoring system can rapidly detect, investigate and respond to any emerging safety issues identified for COVID-19 vaccines.

The post-market monitoring relies on reviewing and analysing adverse events reports, working with international regulators and reviewing medical literature, media and other potential sources of new safety information.

Weekly safety reports can be accessed through the Communicating COVID-19 Safety information.

Contact us for further information

If you require additional information, please email us at queries@vaxine.net

For media enquiries, please email media@vaxine.net

For volunteer enquiries, please email volunteer@vaxine.net