DCGI approves Covishield, Covaxin for immediate use

The Drug Controller General of India (DCGI), on Sunday, gave its approval to two of India’s vaccine candidates for the soon-to-start mass vaccination programme against COVID-19.

DCGI V.G. Somani gave his approval a day after the Centre’s Subject Expert Committee (SEC), under the Central Drugs Control Organisation (CDCO), gave its nod for the Covaxin produced by Bharat Biotech. On Friday, the committee had approved the Oxford-AstraZeneca Covishield vaccine produced by the Serum Institute of India (SII).

The expert panel has recommended ‘restricted clearance’ for the two vaccines in the wake of the present pandemic situation. Both SII and Bharat biotech will need to send in data and outcome reports to the government every 15 days for the first two months.

The quick approval by the SEC came in the wake of the new and mutant UK strain being reported from across the world.

Soon after, Prime Minister Narendra Modi tweeted: “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.”

It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.

— Narendra Modi (@narendramodi) January 3, 2021

SII chief executive officer Adar Poonawalla said the stockpiling of the vaccine had paid off. He said the vaccine was ‘safe effective and ready to roll out in the coming weeks.’

Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK

— Adar Poonawalla (@adarpoonawalla) January 3, 2021

Meanwhile, the country also completed a vaccination dry run in all states ahead of operationalising the massive drive. The dry run was intended to assess the strength and robustness of the system and to ascertain if the standardised procedures would work as the programme is rolled out.

In the first phase of the vaccination drive, almost one core health workers and two crore frontline workers will be given the drug. The modalities of the second phase, expected to begin in July, were being worked out, Union Health Minister Harsh Vardha had said on Saturday.

Dr. Vardhan said the government would not compromise on any protocols at any stage of approval.