India tests vaccine delivery system with nationwide trial

Sunday, 03 Jan, 2021

"Not just in Delhi, it will be free across the country", Vardhan said when asked for the government's position on the issue. Now, Drug Controller General of India (DCGI) will take a final call on rolling out the inoculation.

In a big development, Indian Govt has now approved the vaccine being developed by Oxford University and AstraZeneca, for emergency usage in India.

The expert panel of the Central Drugs Standard Control Organisation (CDSCO) will hold its key meeting on Friday and discuss granting emergency use authorisation to Oxford-AztraZeneca coronavirus vaccine "Covishield", which is being jointly developed by Serum Institute of India (SII), in the country. The company has been contracted by AstraZeneca to make 1 billion doses for developing nations, including India.

From installing freezers to setting up cold chain equipment, arrangements are being made at a Delhi government hospital here for storing the vaccine, whenever it arrives. That's a daunting task, given the country's vast territory, limited infrastructure and patchy health networks.

According to sources, Covishield has been recommended based on the human trial results in the the United Kingdom, the United States of America and India.

Uncertainty has swirled over the most effective dosing pattern for the AstraZeneca/Oxford vaccine since it released data last month showing a 90 per cent success rate for a half-dose followed by a full dose, but only 62 per cent - still usually more than enough for regulators - for two full doses.

The CDSCO, whose experts were meeting for the second time this week, could also approve a vaccine locally developed by Bharat Biotech, two of the sources said on condition of anonymity.

The AstraZeneca-Oxford vaccine is now undergoing a "rolling review" which allows the EMA to examine safety and efficacy data as they are released, even before a formal application for authorisation is filed by the manufacturer.

While trial results published in The Lancet found the vaccine to be safe and effective, more analysis will be needed to see how well it works in people over 55, who are among those at higher risk from the pandemic. It was expected that India would approve the shot shortly after UK.

Trials for CNBG's candidates have recruited over 60,000 participants aged between 18-60, Yang said. Pune-based Serum has denied the claims and said the volunteer's illness had nothing to do with the shot.

The vaccine, dubbed Covishield in India, will cost somewhere between Rs. 700 and Rs. 800 for the private market, SII's CEO Adar Poonawalla had said earlier.

We will keep you updated, as more details come in.