Updated: November 20, 2020 7:55:20 AM
The Indian Serum Institute (SII) is likely to apply to India’s best drug regulator next month for urgent approval for limited use of Covishield for first-line workers and the elderly, said the CEO of the vaccine-based manufacturer. in Pune at a media summit on Thursday.
Covishield is the name in India of the vaccine candidate Covid-19, developed by the University of Oxford and AstraZeneca. Promising results on the effectiveness of the candidate in vulnerable age groups were published in The Lancet on Thursday.
The candidate, produced by SII under an agreement with Oxford-AstraZeneca, is leading India’s own race to find a vaccine to defeat the new coronavirus.
Covishield is likely to be available to the rest of the public by March-April 2021, SII CEO Adar Poonavala said at the HT summit.
The vaccine, which can be stored at temperatures between 2 ° C and 8 ° C, could cost between 500 and 600 Rs in the private market to the general public, Poonawalla said.
The government, he said, would receive the vaccine at a “much lower price” of about $ 3-4 (approximately Rs. 225-300), “because it will buy large quantities” of “hundreds of millions” of doses.
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But “the general public, as I mentioned, will probably have to pay around 500-600 rupees,” Poonavala said, adding that this would be “far cheaper and more affordable” than some of the other vaccines on the market today.
“As soon as the UK authorities – MHRA (Medicines and Health Products Regulatory Agency) – and the European EMEA (European Medicines Agency) approve it for emergency use, we will apply for the Drug Controller (DCGI) in India and hopefully “Very soon we can get an emergency use permit,” said Poonawalla.
“Again, this will be – just to clarify – limited use for front-line workers, the elderly … it will take another three to four months before it becomes available to the general public, because that’s the way it’s likely to be. “Emergency licensing will work,” he said.
“We base the assumption of emergency licensing based on positive results in the UK … if we have a good result in the UK at the end of November – beginning of December, we are applying for emergency licensing. So, you have a vaccine for – again – vulnerable populations until January-February and then … March-April for the general public, “said Poonawalla.
“If everything goes according to plan, these are the deadlines we are considering.”
As India seeks about 300-400 million doses of Covid-19 vaccine by July 2021, SII is “preparing” to increase production and still have “several hundred million” doses to offer to the Gavi-led COVAX mechanism. “The vaccine alliance,” Poonavala said.
“We currently have a capacity of 50-60 million doses on a monthly basis as a way out. By February, we will reach 100 million doses a month, “he said.
The company has already set aside two facilities for the production of this vaccine and will set aside two more by February to double its monthly production for both India and COVAX. These additional facilities are currently being confirmed.
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