Mumbai: Serum Institute of India on Tuesday said it will be starting trials of the COVID-19 vaccine candidate developed by Oxford University and AstraZeneca by the end of August on up to 5,000 Indian volunteers after getting the necessary nods, and launch the vaccine by June next year if all goes well.
The vaccine will ultimately cost Rs 1,000, said the Indian firm partnering the UK researchers.
The Pune-based company's chief executive Adar Poonawalla said the company, which is the largest vaccine maker in the world, is putting $200 million at risk by manufacturing nearly 300 million doses before the final nod to launch the vaccine in market, which is expected at best by the end of the year.
Oxford University on Monday announced satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world.
The varsity has tied up with Serum Institute of India (SII) to manufacture and supply the vaccine to India and over 60 other countries having a combined population of 3 billion, Poonawalla said.
"We are making this application within the next 48 hours to the Drug Controller General of India's office. They will probably take about 1-2 weeks on what kind of study and trial we will have to do," Poonawalla said, speaking to CNBC-TV-18 news channel.
It will take another three weeks to inject patients in hospitals, he said, adding, "We are talking about a month or month and half maximum from today...may be even sooner."
The vaccine under development will be injected into 4-5,000 volunteers in Pune and Mumbai - which have high rates of coronavirus infections - as part of the crucial phase three of the trial which will determine if the antidote can be introduced in the market or not.
Poonawalla said there is no dearth of volunteers and added that unlike the exclusion of older people in the initial phase of trials at Oxford, the Indian trials will include elderly people and health workers as well because the initial phase has conclusively proven the safety of the vaccine.
Parallel to the process of applying for trials and having actual trials on humans in India, the company will be applying for a special permission to start manufacturing the vaccine in the country, which exposes it to a commercial risk if the vaccine fails at the last stage, he said.
As part of the special permission, the company will manufacture up to 70 million doses of the vaccine per month up to October, and plans to take it up to 100 million per month by December, so that it is ready to hit the market once the final approvals are in place.
If this goes to plan, the phase three trials will take two months after the patients get injected and the vaccine gets a final nod by November, he said, adding that in such a scenario, it can get introduced either in "quarter one or two" of next year.
The company has already manufactured around 2-3 million doses of the vaccine for getting the process correct and also stabilising its machinery, Ponnawalla said, clarifying that these will never be used on humans.
"If you look at the process right now, the risk of the opex (operating expenditure) which we are putting in is more than $200 million. If this vaccine fails, we will be down (by) $200 million," he said, adding the expenses exclude the opportunity cost of using the same facility for some other purpose.
Poonawalla also said SII is looking at external investors for the vaccine-related endeavour and added that it has tie-ups with five other vaccine candidates which will be housed into a separate step-down subsidiary, where the family will dilute its stake by 15-20 per cent.
Apart from the five tie-ups already forged, SII is in talks with two other candidates, he said, adding that a manufacturing plant with capacity to produce 1 billion units of the vaccine per year will also get housed in the subsidiary.
He further said it is extremely likely that the COVID-19 vaccine would require two or more doses, like in the case of antidotes for measles and other diseases.
"We have got a lot on the line and bet big on this (Oxford-AstraZeneca) candidate. And we really hope it works," he added.
Meanwhile, Poonawalla Group Chairman Cyrus Poonawalla said SII is committed to producing 1 billion doses of the COVID-19 vaccine after it gets the necessary approvals.
He was speaking at an online discussion organised by FICCI Ladies Organisation (FLO), Pune Chapter.
The company wants to make the vaccine available at the lowest price possible so that even the poor can afford it, a statement quoted Cyrus Poonawalla as saying.
Asked if there could be any setback in terms of productivity and output of the vaccine, he said chances of failure look remote.
If the approvals are in place and trials are completed successfully, then lot of companies will manufacture the vaccine and India will be the largest producer of the COVID-19 vaccine in the world, he added.
Govt will ensure regulatory facilitation for SII's phase 3 trial
India will ensure regulatory facilitation and actively consider supplementing resources for expediting the Serum Institute of India's phase 3 trial of a vaccine for COVID-19 developed by Oxford University.
Asked if the Centre would be providing the same expedited process to SII as it provided to Bharat Biotech along with any funding support, NITI Aayog member V K Paul said, "Regulatory facilitation will be ensured. It is already being undertaken. If resources need to be supplemented, that will also be actively considered."
"The government of India will leave no stone unturned to ensure that people of India and the international community have access to an Indian vaccine as early as possible," he said.
Over multiple vaccines being developed across the world, Paul said two vaccines have showed immunogenecity and reactogenecity - the Wuhan and the Oxford vaccine - and the initial results showed they are safe which is encouraging. He also said that two indigenous vaccines are in phase 1 and 2 of human trials.
The Drugs Controller General of India (DCGI) has permitted two vaccines - one developed by the Bharat Biotech International Limited in collaboration with the ICMR and another one by Zydas Cadila Healthcare Ltd - to go in for phase 1 and 2 human clinical trials.
"It looks promising, not just for India, but for the entire humanity. As we are moving towards the availability of a vaccine and the manufacturing will start, talks on how the government will procure and distribute them so that the needy gets it, have already been initiated," he said.
A coronavirus vaccine developed by the University of Oxford appears safe and induces a strong immune response within the body, scientists announced on Monday after the first phase of "promising" human trials against the deadly disease that has infected over 1.45 crore people and claimed more than six lakh lives across the world.
Doses of the vaccine were given to 1,077 healthy adults, aged between 18 and 55, in five UK hospitals in April and May as part of the phase one clinical trial, and results were published in the 'Lancet' medical journal.
The results showed they induced strong antibody and T-cell immune responses for up to 56 days after they were given. T-cells are crucial for maintaining protection against the virus for years.
(With PTI inputs)
