Price, trial timeline of Serum Institute’s Covid-19 vaccine
Serum Institute of India (SII), the world’s largest maker of vaccines by volume, has partnered with biopharmaceutical company AstraZeneca to manufacture the experimental Covid-19 vaccine candidate developed by University of Oxford.
Adar Poonawalla, SII’s chief executive officer, said they will launch the vaccine under the brand name of Covishield if the trials are successful both in the United Kingdom and in India.
The potential coronavirus vaccine developed by 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 more than 14 million people and claimed over 600,000 lives across the world.
Doses of the vaccine were given to more than 1,000 healthy adults, aged between 18 and 55, in five UK hospitals in April and May as part of the phase one clinical trial, according to trial results published in The Lancet medical journal on Monday.
The vaccine prompted no serious side effects and elicited antibody and T-cell immune responses with the strongest response seen in people who received two doses.
AstraZeneca has tied up with Pune-based Serum Institute to manufacture and supply the vaccine to India and more than 60 other countries having a combined population of 3 billion.
Serum Institute is going to produce 3 to 4 million doses of the experimental Covid-19 vaccine candidate developed by Oxford University and AstraZeneca by December this year, Poonawalla has said.
“We will be going for large scale manufacturing in mid-August-early-August… By the end of this year, we should be able to produce 3 to 4 million doses come end of December. That’s the target and I hope we can do that,” Poonawalla said in an interview to a news channel.
The company will manufacture up to 70 million doses of the vaccine per month up to October as part of the special permission 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 the “first quarter of 2021”.
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.
He added 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.
Price of Covishield
Poonawala said they expect the vaccine to reach the people of India in large numbers by the first quarter of 2021.
“We are going to give it at a very affordable price… We are planning to put it at about Rs 1000 or less than that… I don’t think any citizen of India or of any other country is going to have to pay for it because it is going to be bought by the government and distributed free,” he said.
“It is going to be very affordable… in line with our general philosophy of giving everything at a very affordable price. We generally don’t want to make a profit at all, in fact, in the Covid crisis and after the pandemic is over, we may look at a more commercial price that could be available in the market,” he said.
The trials of the Covid-19 vaccine candidate will start by the end of August on up to 5,000 Indian volunteers after getting the necessary nods and the company will launch Covishiled by June next year if all goes well.
“The vaccine under development will be injected into 4,000-5,000 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,” he said.
Poonawalla said 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.
SII, Poonawalla said, is putting $200 million at risk by manufacturing nearly 300 million doses before the final nod to launch the vaccine in market.
“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 the 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 a half maximum from today...maybe even sooner.”
Other than the process of applying for trials and having actual trials on humans in India, the company will also be applying for 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.
“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%.
Apart from the five tie-ups already forged, SII is in talks with two other candidates, he said, adding that a manufacturing plant with a capacity to produce 1 billion units of the vaccine per year will also get housed in the subsidiary.
(With agency inputs)