Australia’s current COVID-19 vaccine crop consists of a shot from the American biotechnology company Pfizer, which we import, and the vaccine from the British-Swedish multinational AstraZeneca, most of which we manufacture on the ground in Melbourne with license.
We currently do not have a locally manufactured COVID vaccine at our disposal, although this week the Victorian government announced funding for a Pfizer-style mRNA vaccine developed by Monash University. It will move to Phase 1 testing in October or November.
However, the most advanced COVID vaccine in development is the trait called “COVAX-19” by South Australian biotechnology Vaxine.
It’s great to see another Australian group at the forefront of COVID-19 research and in particular vaccine development.
The candidate has a phase 2 clinical trial has just begun in Iran, collaborating with local biotechnology CinnaGen.
We have not yet seen published results from preclinical studies in animals or phase 1 trials in humans, although Vaxine states that it has submitted research work and is pending acceptance.
At this time, unfortunately there is not enough information to comment on the safety and efficacy of this locally developed vaccine, although it is potentially promising.
More information, in particular the results of the clinical trials, is eagerly awaited.
What is Vaxine?
Vaxine was founded in 2002 with the goal of developing new vaccine technologies.
Vaxine researchers have long focused on adjuvants, which are substances added to vaccines to improve the immune system’s response. They have done it they developed their own adjuvant called “Advax” which is based on Inulin, a starch product derived from many plants.
What kind of vaccine is it?
Vaccine scientists began working on a COVID-19 vaccine in January 2020. They describe the development of various types of vaccines, but eventually settled on a “protein-based recombinant vaccine.”
The goal of any vaccine is to train our immune system to recognize something that is on the surface of a pathogen, in this case the SARS-CoV-2 coronavirus. Having a vaccine means that if we come across this virus, we will have antibodies and other immune cells ready to protect us.
In the case of COVID-19, most vaccines in use and in development target the ear protein, as it is the part of the virus that binds to human cells to enter it and cause infection.
Vaxine’s COVAX-19 is no exception and it does so by manufacturing spike protein in the lab using “recombinant technology,” which is where proteins are artificially made.
Other similar vaccines include those made by Novavax and the University of Queensland.
The Novavax candidate uses his own adjuvant and this month has announced impressive results phase 3 studies.
The University of Queensland candidate used a “molecular clamp” that unfortunately caused some participants who received the vaccine in trials to have false positive HIV tests. Therefore, the vaccine will not progress beyond the phase 1 clinical trials.
Is it safe and effective?
The Vaxine website indicates its COVAX-19 vaccine has been shown to produce an immune response in several animals, including mice, macaques, and ferrets. The data is not published, so I cannot confirm it.
For the results to be published, it means that they have been carefully analyzed and presented, as well as undergoing a robust peer review process. Although it results from press releases and prepress articles can tell us that exciting results could have been obtained, we really need to see them published in reputable peer-reviewed journals to make sure they are of sufficient quality to draw reliable conclusions.
However, the company’s founder and research director, Nikolai Petrovsky, said he has submitted a paper on his studies on mice and ferrets and is awaiting acceptance.
Based on this unprecedented preclinical work, this vaccine was evaluated in a phase 1 human trial that began on June 30 last year.
Clinical trials typically go through three phases:
- phase 1 trials are the first trials in humans, usually small and focused primarily on safety
- phase 2 trials are a little bigger, although they focus mostly on safety, but we start to study a little more how well it really works
- phase 3 are broader studies, although they consider safety, but focus mainly on the effectiveness with which the vaccine reduces infection or disease.
In the Phase 1 trial of Vaxine, 40 participants aged 18 to 65 years were included, with 30 people receiving the active vaccine and ten receiving a saline placebo.
The company’s website says Preliminary data from this phase 1 study showed that the COVAX-19 vaccine is safe, well tolerated, and produces an immune response, although data from this trial are not published.
Petrovsky said that this data has also been sent and that it is pending acceptance. He said the company’s main goal is to advance clinical trials and prepare to produce hundreds of millions of doses, if successful.
He added: “We just don’t have the luxury of having too much bandwidth to write and publish articles at the same time.”
He phase 2 clinical trials began on May 30 in Iran, with 400 volunteers injected with a placebo or the first dose of the vaccine candidate.
This is a step in the right direction. But even if the published results of phase 1 confirm safety and efficacy, given that the phase 2 trial has only just begun and phase 3 is great essays they are still needed, unfortunately it will be a while before we know if this is a safe and effective vaccine.
The speed with which the vaccine could be disposed of also largely depends on Vaxine’s ability to increase production, which is a considerable investment and a fairly long period of time.
Citation: What is COVAX-19, the most advanced of the other COVID vaccine candidates in Australia? (2021, June 23), retrieved June 23, 2021 from https://medicalxpress.com/news/2021-06-covax-advanced-australia-local-covid.html
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