Serum Institute of India (SII) will likely apply to India’s top drug regulator next month for emergency approval for limited use of ‘Covishield’ on frontline workers and the elderly, the CEO of the Pune-headquartered vaccine manufacturer said at a media summit on Thursday.
Covishield is the name in India of the Covid-19 vaccine candidate developed by the University of Oxford and AstraZeneca. Promising results about the effectiveness of the candidate in vulnerable age groups were published in The Lancet on Thursday.
The candidate, which is being manufactured by SII under an agreement with Oxford-AstraZeneca, is the frontrunner in India’s own race to find a vaccine to defeat the novel coronavirus.
Covishield is likely to be available for the rest of the public by March-April 2021, SII CEO Adar Poonawalla said at the HT Leadership Summit.
The vaccine, which can be stored at temperatures between 2°C and 8°C, could cost between Rs 500 and Rs 600 in the private market for the general public, Poonawalla said.
The government, he said, will get the vaccine at “a much lower price” of around $3-$4 (approximately Rs 225-300), “because they will be buying large volumes” of “hundreds of millions” of doses.
But “the general public, as I mentioned, will probably have to pay around Rs 500-600,” Poonawalla said, adding that this would be “far cheaper and more affordable” than some of the other vaccines in the market today.
“As soon as the UK authorities – the MHRA (Medicines and Healthcare products Regulatory Agency) – and the European EMEA (European Medicines Agency) approves it for emergency use, we will apply to the Drug Controller (DCGI) in India and, hopefully, very soon, we can also get an emergency use authorisation,” Poonawalla said.
“Again, that will be – just to clarify – a limited use for frontline workers, the elderly…it’s going to take another three to four months before it’s available to the general public, because that’s the way the emergency use licensure will probably work,” he said.
“We are basing the assumption of an emergency licensure based on positive UK results…if we have a good UK result coming in end of November-early December, we apply for an emergency licensure use. So, you have the vaccine for – again – the vulnerable populations by Jan-Feb and then…March-April for the general public,” Poonawalla said.
“If all that goes according to plan, these are the timelines we are looking at.”
With India seeking around 300-400 million doses of a Covid-19 vaccine by July 2021, SII is “gearing up” to increase its output, and to still have “a few hundred million” doses left to offer to the COVAX mechanism led by Gavi, The Vaccine Alliance, Poonawalla said.
“At the moment, we’re at a 50-60 million dose capacity on a monthly basis as an output. By February, we will have gone to 100 million doses per month,” he said.
The firm has already dedicated two facilities towards manufacturing this vaccine and will dedicate two more by February to double its monthly output for both India and COVAX. These additional facilities are currently getting validated.