Serum Institute of India’s Chief Executive Officer Adar Poonawalla on Wednesday said the Oxford vaccine, which his company is producing, may be ready by December and the first batch of 100 million doses should be available by the second or third quarter of 2021. He told NDTV that the company may also apply for emergency use licence.
Serum’s Covishield, which is being developed at the Oxford University in the United Kingdom and licensed by international biopharma company AstraZeneca, is currently undergoing the final phase of clinical trials in India. The Serum institute has already produced over 20 lakh doses of the vaccine candidate for use in testing.
Poonawalla said he was hopeful about launching Covishield by January. “If we don’t go for an emergency license, our trials should be over by December and then we can maybe we can launch in India in January,” he said. But Poonawalla added that Serum’s plans are subject to the United Kingdom clinical trials that are “on the verge of being completed”.
“If the UK in the next two weeks were to unblind their study and share the data and be confident that it’s safe, then we can – after two-three weeks – apply to the Indian regulator to look at a possible emergency licence if that’s what the government of India wants,” he said. An Emergency Use Listing is meant to make a vaccine available globally faster.
However, Poonawalla said a lot of this would depend on the approvals coming through from the Drugs Controller General Of India. “That review could take about two-three weeks I imagine and then you can have a vaccine by December, but all these would have to happen and I don’t want to venture a guess... because it’s not my place to do so – that’s for the health ministry officials to decide.”
India has not yet signed a deal for a coronavirus vaccine so it is unclear when it will be available for use in the country, despite some leaders promising it will be available from as early as January. So far, many other nations including the US, UK, the European Union, Australia and Israel have made deals to buy millions of doses of the vaccines. Availability of the vaccine in India will be subject to approval by domestic regulators, and the Indian government agreeing to purchase them.
The Serum Institute of India is the world’s largest manufacturer of vaccines by volume, producing 1.5 billion vaccine doses annually mostly for countries for the developing world.
The third and final phase of clinical trials of Covishield continued last month in India after they were paused briefly following an “unexplained illness” in a test subject during trials in the UK. American study sites, however, have yet to restart the trials.
Poonawalla told NDTV that there are no immediate concerns about the Oxford vaccine. “The vaccine is very safe,” he said. “Thousands of people have had it in India and abroad so we’re cracking on. On track with no safety concerns.”
But the executive said that although the early indicators were positive, it would still take “a year or two” to be certain that the vaccine candidate will have a long-term effect”. “The vaccine, when we have one, will be a two-dose vaccine,” he added. “The gap between the two doses will be 28 days.”
Elaborating on the general availability of the vaccine, he said: “We are aiming for 100 million available doses at first. This should be available by Q2-Q3 of 2021.”
“It’s going to be very affordable,” he added. “It’ll be a few hundred rupees and it’s going to be way cheaper than even a test – a RT-PCR test today or a rapid antigen test. The government will take most of that load on, financially, and that conversation is going on very well as well.”
India’s coronavirus tally rose to 80,40,203 on Thursday as it recorded 49,881 new cases in 24 hours. The country’s toll went up by 517 to 1,20,527.