Nikolai Petrovsky, professor of medicine at the Flinders University in South Australia, is leading the research for COVAX coronavirus vaccine.
“We have been doing phase-1 clinical trials and have done a lot of animal studies and the plan for next year is to take the vaccine into phase-3 clinical trials," he says.
The COVAX vaccine is based on the synthetic-protein, as opposed to the mRNA technology used in other vaccines.
“The mRNA technology is being used for the first time in humans. Obviously, we know a lot less about them at this stage, than we do about synthetic-protein approaches that we take,” says Prof Petrovsky.
The other vaccines based on mRNA (DNA) are being developed by international pharmaceutical companies, such as Pfizer, and now being used in the United States.
We are definitely making progress but it is not easy and there are lots of challenges along the way.
Pakistani volunteers wait to get trial vaccination for COVID-19, developed by China's CanSino Bilogics and Beijing Institute of Biotechnology, in Islamabad. Source: AAP Image / EPA
Professor Petrovsky says the COVID-19 vaccine they are making is similar to vaccines for Hepatitis B or some influenza vaccines.
The Australian synthetic protein vaccine is based on insect cells, such as caterpillars.
Stages of Clinical Trials
Vaccines go through three stages of clinical trials. Phase 1, the vaccine is trialled on 40 – 100 subjects to find out whether it is safe for humans or not. Phase 2 trials consist of 100 – 400 subjects, in which the size of the dose is evaluated that works best for humans. The third phase of the clinical trial determines how effective the vaccine is.
Professor Petrovsky says the main challenge during the third phase is the number of subjects.
“One of the challenges of phase 3 trials is to have 10,000 to 15,000 subjects typically, and it needs to be done in a country where there is a lot of diseases. In this case, a lot of COVID-19 infections."
“We simply can’t do phase 3 trials in Australia because we simply don’t have any community transmission of the virus that would enable us to do the trial to prove if it is effective," he told SBS Urdu.
He says Vaxine - the Australian biotech company conducting the research - is in "very advanced stages of discussions" to undertake at least part of its phase 3 trial in Pakistan. The company also plans to conduct trials in Nepal and some Eastern European countries next year.
A member of Pakistan’s Scientific Task Force on COVID-19, Dr Javed Akram, has told that the trial of the Australian vaccine will be next year.
Pakistani volunteers wait to get trial vaccination for COVID-19, developed by China's CanSino Bilogics Inc and Beijing Institute of Biotechnology. Source: AAP/EPA/SOHAIL SHAHZAD
“The Australian vaccine will be similar to the Chinese one as it also works on spikes and will be injected. However, it will be prepared in the flies' bodies, which is why it is called an insect-based vaccine.
“It is Australian, insect-based, vaccine and arrangements are being made to get approval from the Drug Regulatory Authority of Pakistan and the National Bioethics Committee,” he said.
The trial of a Chinese vaccine is already underway in Pakistan, and are likely to conclude this month.
Professor Petrovsky says the phase 3 clinical trials will take at least the first quarter of next year to complete.
“With a positive outcome, we expect the vaccine to become available before the end of next year.”
