Scientists and researchers at Vaxine, a South Australia based company, are currently developing a vaccine called Covax-19 and are working with authorities in the Himalayan nation to begin the third phase of its trial.
If approved by authorities, the third phase of the trial could start by the end of 2020.
The Morrison a funding grant of $1 million to the company as 'part of its effort to support 'research and development' of Australian COVID-19 vaccines.
Professor Nikolai Petrovsky, research director at Vaxine, is currently leading the vaccine development team and told SBS Nepali why they want to conduct tests for coronavirus vaccine in Nepal.
The federal government is investing almost $6 million in additional research and development for three Australian COVID-19 vaccines. Source: Moment RF
He says Phase 3 studies need to be undertaken in countries with a high rate of COVID-19 spread and is exploring the involvement of many countries in Asia, the Middle East, and Central and South America.
"Conducting such trials takes a lot of effort and commitment, and our collaborators in Nepal have shown great enthusiasm about our Covax-19 vaccine, providing us with confidence in their ability to make the Nepal arm of our trial a big success," says Professor Petrovsky, who also works at the College of Medicine and Public Health at Flinders University.
Dr Meghnath Dhimal of the National Health Research Center (NHRC) in Nepal confirmed the South Asian nation is in talks with the Australian researcher.
"We have had preliminary conversations with Professor Nikolai Petrovsky, and we are hopeful that things will progress into testing soon," Dr Dhimal said.
As several countries around the globe race to make the first safe and successful vaccine for SARS-COV-2, countries like Nepal are in negotiations with leading developers of a vaccine.
Vaxine research director Nikolai Petrovsky in the Flinders University lab with a vaccine specimen, Thursday, July 2, 2020. Source: AAP
Dr Dhimal says they are in talks with several countries for phase 3 clinical trials of the coronavirus vaccine and Australia is one of them.
China, Russia and the Oxford University in Britain are some of the other developers of a possible vaccine that Nepali authorities are currently dealing with.
However, so far, Nepal has not confirmed it is going ahead with any yet.
"We are awaiting detailed proposals from them," says Meghnath Dhimal.
COVAX-19 Source: COVAX
Ethical and Safe?
Professor Petrovsky says the research and development carried out by his team for the vaccine is "ethical" and is "different" from other producers.
He says some of the large multinational companies are mainly concentrated on getting large vaccine orders from wealthy countries. In contrast, he claims that he is keen on making his product available to the most disadvantaged countries in the world.
"Protein-based approaches have been used for many human vaccines in the past and are widely accepted as the safest type of vaccine," he says.
But the variant of vaccine he is producing is a "synthetic spike protein" combined with sugar-based "Advax" adjuvant technology, which the company says, "enhances antibody and T-cell responses against co-administered antigens."
"By contrast, Oxford/Astra Zeneca, Modena and Pfizer/BioNTec and all using highly experimental as yet unproven technologies that have not previously been tested in humans," Nikolai Petrovsky claims.
"This translates to higher risk of failure given their unknown effectiveness, long term safety and durability."
Australia's first locally made COVID-19 mRNA vaccine candidate is set for clinical trials Source: AAP
The NHRC says whilst Nepal welcomes all international researchers, they need to fulfil the technical and ethical requirements and must complete Phase 1 and 2 of the trials.
Professor Petrovsky is optimistic his Phase 3 trials can start before the end of the year.
"Ultimately, the Phase 3 trial is all that stands between us and getting the vaccine approved for use, so this is a critical hurdle we must overcome," he says.
How are trials conducted?
After pre-clinical trials, clinical trials of vaccines are done in several phases.
Phase 1 is conducted on a small number of healthy volunteers in the sponsor's home country.
Phase 2 is conducted on a broader scale, again on volunteers, and maybe international with about 10,000 participants.
The first two phases test the vaccine's safety and efficacy in controlled situations.
Türkiye'deki aşı kampanyası Çinli Sinovac Biotech'in geliştirdiği aşıyıkullanıyor. Source: AAP
The third phase of testing must be carried out with large groups of trial participants before the vaccine can be approved for use.
After safety is proven through the first two phases, Phase 3 trials look for its effectiveness in real-world scenarios.
Only Phase 3 testing allowed in Nepal
"Nepal's standards for such trials are quite strict, and at par with international standards," says Dr Prakash Ghimire, who leads the independent Ethical Review Committee at NHRC.
International researchers who want to conduct trials in Nepal must submit their proposals to this committee, which checks their proposals according to their guidelines before approving them.
"The proposal should fulfil all technical and ethical requirements, list adverse impacts, provide complete information about insurance and medical care in case of adverse effects, and a principal investigator in Nepal to take the primary legal responsibility for everything, says Dr Ghimire.
"The publications of results of Phase 1 and phase 2 trials should be included, and they should prove that the object being tried is effective, non-maleficent, and independent. The project should also uphold the participants' confidentiality."
Nepal government formally ended the nationwide lockdown enforced from March 24th to stem the spread of coronavirus. Source: AAP
The participants of the trial proposed by Professor Petrovsky are not known yet, and according to Nepali law, the participants will be voluntary, they will not be compensated.
Apart from a nominal transport fee, Nepal's laws prohibit compensation for such trials, and voluntary participation is based on written informed consent.
Professor Petrovsky says it is the local authorities who set the required criteria for the participants when they review the clinical trial application.
"However, we want to make the trial as broadly inclusive as possible, as the great strength of Covax-19 vaccine is that we designed it to be effective and safe in essentially all populations," he says.
NHRC will monitor whether the researchers are providing complete information on the side effects to the participants.
NHRC says testing for coronavirus vaccine can begin when the formalities are completed.
Dr Nikolai Petrovsky Source: Vaxine
But it's not just the bureaucratic hurdles that Prof Petrovsky and his team at Vaxine need to cross.
He says the most significant encumbrance is securing funds for vaccine development.
"The biggest hurdle is finding the funding as a Phase 3 trial can cost hundreds of millions of dollars to undertake," Petrovsky said.
But he is hopeful of beating this challenge.
"All the immunizations have been completed for the Phase 1 trial, and a safety analysis shows that the vaccine has been well-tolerated, and there were no serious adverse events," he says.
"The next step is to enter into the critical Phase 3 trial."
Australia joins global COVAX pool
Australia is now to buy COVID-19 vaccine doses, when they become available, through the global COVAX facility.
The COVID-19 facility known as COVAX gives Australia access to a broad portfolio of vaccine candidates and manufacturers across the world.
Australia has committed an initial $123.2 million to be part of the facility's purchasing mechanism, making it eligible to receive offers to buy vaccines when they become available.
People in Australia must stay at least 1.5 metres away from others. Check your state’s restrictions on gathering limits.
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