Updated 20th November 2020 | 09:06 IST
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 therefore the elderly, the CEO of the Pune-headquartered vaccine manufacturer said at a media summit on Thursday.
Covishield is that 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 within the Lancet on Thursday.
The candidate, which is being manufactured by SII under an agreement with Oxford-AstraZeneca, is that the frontrunner in India’s own race to seek out a vaccine to defeat the novel coronavirus.
Covishield is probably going to be available for the remainder of the general public by March-April 2021, SII CEO Adar Poonawalla said at the HT Leadership Summit.
The vaccine, which may be stored at temperatures between 2°C and 8°C, could cost between Rs 500 and Rs 600 within the private marketplace for the overall 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’re going to be buying large volumes” of “hundreds of millions” of doses.
But “the general public, as I discussed, will probably need to pay around Rs 500-600,” Poonawalla said, adding that this is able to be “far cheaper and more affordable” than a number of the opposite vaccines within the market today.
“As soon because the UK authorities – the MHRA (Medicines and Healthcare products Regulatory Agency) – and therefore the European EMEA (European Medicines Agency) approves it for emergency use, we’ll apply to the Drug Controller (DCGI) in India and, hopefully, very soon, we will also get an emergency use authorisation,” Poonawalla said.
“Again, which will be – just to clarify – a limited use for frontline workers, the elderly…it’s getting to take another three to four months before it’s available to the overall public because that’s the way the emergency use licensure will probably work,” he said.
“We are basing the idea of emergency licensure supported positive UK results…if we have an honest UK result coming at the end of November-early December, we apply for an emergency licensure use. So, you’ve got the vaccine for – again – the vulnerable populations by Jan-Feb and then…March-April for the overall public,” Poonawalla said.
“If all that goes consistent with the plan, these are the timelines we are watching .”
With India seeking around 300-400 million doses of a Covid-19 vaccine by July 2021, SII is “gearing up” to extend its output, and to still have “a few hundred million” doses left to supply to the COVAX mechanism led by Gavi, The Vaccine Alliance, Poonawalla said.
“At the instant, we’re at a 50-60 million dose capacity on a monthly basis as an output. By February, we’ll have gone to 100 million doses per month,” he said.
The firm has already dedicated two facilities towards manufacturing this vaccine and can dedicate two more by February to double its monthly output for both India and COVAX. These additional facilities are currently getting validated.