Serum Institute of India (SII), the world’s largest vaccine maker by volume, is expecting emergency use authorisation for its Covid antidote in a couple of days, Adar Poonawalla, chief executive officer (CEO), told reporters on Monday.
Poonawalla said Covishield, the vaccine of Oxford-Astra Zeneca, with which SII has an alliance, was once likely to receive emergency use approval in the United Kingdom in a couple of days and could also safe the regulator’s nod concurrently in India.
“We will be able to get some good news in this new year … All of the data has been submitted and we will have to respect the process as regulators are evaluating the data.”
Pune-based SII has stockpiled 40-50 million doses of the vaccine and is adding more each week. These types of volumes will come to India, Poonawalla said, since exporting to other countries would require assembly pre-qualification procedures of the World Health Association, which will take time.
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The company will be capable to produce 100 million doses when its third facility becomes operational by March next year.
“Once we get regulatory approvals in a couple of days, it is going to depend upon the government to make a decision how much they may be able to take and how fast,” Poonawalla said.
COVAX, often referred to as the COVID-19 Vaccines Global Access Facility, of which India is a part, has an agreement with SII for 200 million doses of the Oxford-AstraZeneca vaccine.
“There will be various vaccines to go around COVAX countries … First of all we may give lots of the volumes to India. We would give 50 per cent of everything we make to India and Covax,” Poonawalla said.
SII expects the initial uptake of the vaccine to be slow in the first couple of months. The vaccine maker will make stronger its capacity to 300 million doses by July.
“Once the logistics have been worked out, we will expect a roll-out in January.”
Poonawalla said with other vaccine manufacturers ramping up production, supply-side issues would ease by August-September.
He was once speaking on the sidelines of the launch of its pneumococcal conjugate vaccine, Pneumosil, priced at $3 per dose, for the public market and a little over $10 per dose for the private market. The vaccine provides protection against 10 variants of the pneumococcus bacteria, which causes pneumonia, meningitis, ear, and blood infection in children.
The subject expert committee currently reviewing SII’s emergency use authorisation application for Covishield had earlier asked the company to supply up to date safety data of the phase two and three trials, immunogenicity data from the clinical trials in the United Kingdom and India, and the outcome assessment of the UK-Medicines and Healthcare Products Regulatory Authority, for granting authorisation.
AstraZeneca CEO Pascal Soriot has said the Covishield vaccine will offer protection to 95 per cent of patients and it is as effective as the Pfizer and Moderna alternatives.
In an interview to the United Kingdom’s Sunday Times, Soriot said the scientists had figured out a “winning formula to receive efficacy up there with everybody else”.
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