Serum Institute of India (SII), the world’s largest vaccine maker by volume, is expecting emergency use authorisation for its Covid antidote in a few 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 likely to get emergency use approval in the UK in a few days and could also secure the regulator’s nod simultaneously in India.
“We will get some good news in this new year … All the data has been submitted and we must 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 every week. A majority of these volumes will come to India, Poonawalla said, since exporting to other countries would require meeting pre-qualification procedures of the World Health Organization, which will take time.
The company will be able to produce 100 million doses when its third facility becomes operational by March next year.
“Once we get regulatory approvals in a few days, it will depend upon the government to decide how much they can take and how fast,” Poonawalla said.
COVAX, also known as the COVID-19 Vaccines Global Access Facility, of which India is part, has an agreement with SII for 200 million doses of the Oxford-AstraZeneca vaccine.
“There will be plenty of vaccines to go around COVAX countries … Initially we may give most 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 enhance its capacity to 300 million doses by July.
“Once the logistics have been worked out, we can 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 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 provide updated safety data of the phase two and three trials, immunogenicity data from the clinical trials in the UK 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 protect 95 per cent of patients and it is as effective as the Pfizer and Moderna alternatives.
In an interview to the UK’s Sunday Times, Soriot said the scientists had figured out a “winning formula to get efficacy up there with everybody else”.