Australian biotechnology company Vaxine Pty Ltd expects to start Phase II trials of its potential COVID-19 vaccine in the next few weeks after "positive" results from the first stage human study, chairman Nikolai Petrovsky said on Wednesday.
Final stage trials could start within the next three months, he told the Reuters Global Markets Forum chat room in an exclusive interview.
"It's extremely safe and well-tolerated. We already have that data from the clinical trial. We've not had any bad reactions to the vaccine. That's very positive," he said.
The company is working with South Korea's MedyTox, according to the World Health Organization's list of candidate vaccines. Human trials on 40 people started this month.
No vaccine has yet been approved for COVID-19, the disease caused by the new coronavirus that has killed more than 659,000 people and unleashed economic havoc worldwide.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Vaxine's shot is one of more than two dozen at the human clinical trial stage as the race to tame the pandemic heats up.
Petrovsky said two years is a realistic but ambitious time frame to get a COVID-19 vaccine to market, underscoring the challenge facing the global drugs industry to help control the virus.
"We may have vaccines that look effective after one year, but to then manufacture billions of doses and get them to people, I think everybody expects two years," he said.
"If you look at measles and polio, where there was a desperate urgency, it still took 4-5 years to develop an effective vaccine."
In terms of pricing, Petrovsky said COVID-19 vaccines could potentially cost between $20 to $200 per dose, depending on the technology's manufacturing cost. He said more effective vaccines, or those with fewer or no side effects may sell at a higher price.
Pfizer's deal with the US government to sell 100 million doses for $2 billion "indicates that the price for a very large volume of vaccine will be around $20, but potentially on the private market, it may be $40-$50 by the time you have mark-ups by chemists and you get to retail," Petrovsky said.
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