Nod for Covid vaccine in the next few days: Serum Institute's Poonawalla

The world’s largest vaccine maker by volume, Serum Institute of India, is expecting emergency-use authorisation for its covid antidote in the next few days, Adar Poonawalla, chief executive officer, SII, told reporters on Monday.

Poonawalla said Oxford-Astra Zeneca’s coronavirus vaccine Covishield is likely to get emergency-use approval in the UK in the next few days and could simultaneously get the regulator’s nod in India. “We will get some good news this new year...All the data has been submitted and we must respect the process as regulators are evaluating data.”

Pune-based SII has stockpiled 40-50 million doses of the vaccine and is adding more every week. Most of these volumes will come to India, Poonawalla said, since exporting to other countries would require fulfilling pre-qualification procedures of the World Health Organisation which will take time.

The company will be able to produce 100 million doses when its third facility becomes operational by March 2021.

“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,” Poonwalla said.

COVAX also known as the Covid-19 Vaccines Global Access Facility, of which India is a part, has an agreement with the Serum Institute of India for 200 million doses of the Oxford- AstraZeneca vaccine. “There will be plenty of vaccine 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 that the initial uptake of the vaccine will be slow in the first couple of months. The vaccine maker will enhance its capacity 300 million doses by July 2021. “Once the logistics have been worked out, we can expect a roll-out in January,” Poonawalla said, adding that with other vaccine manufacturers ramping up production, the supply side issues will ease by August-September 2021.

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 little over $10 per dose for the private market. The vaccine provides protection against 10 variants of pneumococcus bacteria that causes pneumonia, meningitis, ear, and blood infections in children.

The subject expert committee currently reviewing SII’s emergency use authorisation (EUA) 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 UK and India and the outcome assessment of the UK-MHRA for grant of EUA.

“The regulator has to be given enough time to ...Global multicenter trials data from the UK, South Africa and not just India is being evaluated,” Poonawalla said.

AstraZeneca CEO Pascal Soriot has said that the Covishield vaccine will protect 95 per cent of patients and that it is as effective as the Pfizer and Moderna alternatives. In an interview to the Sunday Times Soriot had said that the scientists had figured out a “winning formula to get efficacy up there with everybody else.”