Scientists at Oxford University say their experimental coronavirus vaccine has been shown in an early trial to prompt a protective immune response in hundreds of people who got the shot.
Oxford coronavirus vaccine, whose results of Phase I, II trials have appeared safe, will be called 'Covishield' in India, says Adar Poonawalla, CEO, Serum Institute of India, a Pune based manufacturing partner of AstraZeneca that will be producing 1 billion doses of the Oxford's corona vaccine.
When will Covishield available in India?
Speaking to NDTV, Adar Poonawalla, said that they have written to the Drug Controller General of India (DCGI) seeking approval for conducting Phase 3 trials of the Oxford coronavirus vaccine in India. If results turned positive, Poonawalla said, "By November, we hope to launch the vaccine if the trials are positive and if the DCGI blesses it and says it is safe..."
When will Covishield Phase 3 trials begin in India?
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.
"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."
Serum Institute of India (SII), the largest vaccine manufacturer in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it gets ready.
What will be the cost of Covishield, vaccine for coronavirus?
Serum Institute of India CEO Adar Poonawalla said that they want to keep its price below Rs 1000.
How many volunteers will be injected with Covishield as part of Phase 3 trials?
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.
Indian trials of Covishield will include elderly people
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.
Oxford coronavirus vaccine Covishield would require two or more doses
Poonawalla 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.
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.
Serum Institute taking a commercial risk?
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 you look at the process right now, the risk of the opex (operating expenditure) which we are putting in is more than USD 200 million.
If this vaccine fails, we will be down (by) USD 200 million," Poonawalla said, adding the expenses exclude the opportunity cost of using the same facility for some other purpose.
What Oxford's coronavirus vaccine Phase I, II trials say
The interim results from the ongoing Phase I/II COV001 trial, led by Oxford University, showed that the vaccine was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants, AstraZeneca said in a statement.
A coronavirus vaccine developed by the Oxford University 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.
The results show 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. The findings are seen as promising, but experts feel it is too soon to know if this is enough to offer protection as larger trials get underway.
Scientists behind the trials found the response could be even greater after a second dose.
"The Phase I/II data for our coronavirus vaccine shows that the vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type."
(With inputs from PTI)
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