If the clinical trials of Covaxin go well and meet the highest safety and efficacy standards, and if the regulators approve of them, it can be available for mass use by early 2021, Dr Krishna Ella, Chairman and Managing director, Bharat Biotech, told Sumi Sukanya Dutta in an interview.
This development of Covaxin entering human trials has raised hopes of the countrymen in the middle of a massive pandemic. Please share details on the origin of the vaccine.
The vaccine candidate was developed by Bharat Biotech India Ltd in collaboration with the National Institute of Virology. NIV isolated a strain of the novel coronavirus from an asymptomatic patient and transferred it to BBIL early in May. We then used it to work on developing an ‘inactivated’ vaccine — a vaccine that uses the dead virus — at our high-containment facility in Hyderabad.
Can you share some details related to safety and immune response seen during the pre-clinical phase studies using this vaccine candidate in animals so far?
The trials resulted in a safe and immunogenic response from all the animals that were tested. We are now commencing towards human trials.
Can you please tell us about the timeline of this vaccine? For instance, when do you think phase 1 and 2 trials will get over and when could it enter the next phase, depending on the results?
At the moment, we are not sure how the vaccine is going to perform in humans, as clinical trials are about to start. Based on the successful results of phase 1 and phase 2, we will progress to the larger clinical trials.
How soon do you think the vaccine can be available for mass usage if everything goes well?
As I said earlier, at the moment we are not sure how the vaccine is going to perform in humans, as clinical trials are about to commence. Based on the successful results of phase 1 and phase 2, we will progress to the larger clinical trials. We are hoping all the studies meet the highest safety and efficacy standards, and if the regulators approve of them, we can expect the vaccine to be available early 2021.
It’s too early to ask anything about its costing yet but can you please share a tentative price range that this vaccine, when commercially available, could have?
As a socially inclined organisation and a company that is focused on public health, we endeavour to deliver world-class vaccines at affordable prices. We have done this earlier and we hope to achieve the same even for Covaxin. We must say that it is too early to make any statement.
What are your views about the mass distribution of the vaccine once it’s available for usage?
The demand for Covid-19 vaccine is enormous and we believe one company can’t serve the entire demand. However, we have built capacities to deliver 300 million doses per year. We need more companies to create manufacturing facilities to serve the world.
Corona cure: Vaccine candidates leading the race
There are nearly 140 Covid-19 vaccine candidates globally in different stages of trial with 16 having entered clinical trials in humans, as per the WHO.
Of these, five are being developed in China, three in the US, two in the UK and one each in Germany, Russia and Australia.
India is hoping to join the league as an indigenously developed vaccine candidate got the drug regulator’s approval for phase 1 and 2 trials this week. Here’s a snapshot of the leading vaccine trials that have raised hopes.
BioNTech-Pfizer
Vaccine candidate: BNT162b1
German biotech firm BioNTech and US pharmaceutical giant Pfizer are developing this RNA-based vaccine. Status of progress: First stage showed promising results. Those who received it were reported to have higher levels of Covid-19 antibodies than infected individuals.
Oxford University
Vaccine candidate: AZD1222
Potential vaccine has been prepared using adenovirus, a virus that causes mild upper respiratory tract infections Status of progress: Is the only potential vaccine in the third stage. Its safety and efficacy is being studied on 8,000 volunteers in Brazil, UK and South Africa. On Wednesday, a scientist associated with the project said the vaccine shot has been found to be safe even for people with weak immunity.
CanSino Biologics
Vaccine candidate: Ad5-nCoV
One of the eight vaccine candidates developed by China. In May, CanSino became the world’s first company to publish a full scientific study on the vaccine’s early human trials. Status of progress: China approved its use by the military on June 25 for a period of one year after phase 1 and 2 clinical trials showed it was safe and also effective to some extent. It has also been approved for human testing in Canada.
Bharat Biotech
Vaccine candidate: Covaxin
Hyderabad based company is working on three vaccine candidates, two of which are with the international collaborators. Covaxin, on which it is working with the National Institute of Virology, has received permission for human trials. Status of progress: Pre-clinical studies of the ‘inactivated’ vaccine demonstrated its safety and immune response figures after which approval for human trials was given.
Inovio Pharmaceuticals
Vaccine candidate: INO-4800
It has been designed to match the DNA sequence of the SARS-CoV-2 virus. US biotech firm Inovio Pharmaceutical claims vaccine recipients will have very specific antibodies against Covid-19.
Status of progress: Recently it was announced that preliminary clinical trials showed encouraging results by triggering strong immune response in 94 per cent of the 40 volunteers. The firm plans to have 1 million doses of the vaccine by the end of 2020 and is set to enter phase 2 and 3 trials.
The trials resulted in safe and immunogenic response from animals that were tested. We are now moving towards human trials