By Raju Vernekar
Pune, Dec 29:
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 media.
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 adding that”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. Once the logistics have been worked out, we can expect a roll-out in January”, “ 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. 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. Poonawalla said with other vaccine manufacturers ramping up production, supply-side issues would ease by August-September.
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.
In the meanwhile, some Indian states began a trial run of COVID-19 vaccine delivery systems, with health authorities checking everything from their technology platforms to the storage infrastructure that will be required to inoculate millions, on Monday.
India wants to deliver 600 million coronavirus shots in the next six to eight months starting in January, with emergency use approval for the Oxford/AstraZeneca vaccine expected within days.
The country’s drug regulator-the Central Drugs Standard Control Organisation (CDSCO), is also considering similar approvals for the Pfizer/BioNTech vaccine and another developed by India’s Bharat Biotech.
In the eastern state of Assam, mock drills and training were carried out in two districts, where vaccinators were given instructions on storing and administering the shots. In the first phase, we shall be administering the vaccine only to healthcare workers. India has the second-highest number of confirmed coronavirus cases in the world after the United States, and it has recorded 147,901 deaths so far.
