The Drugs Controller General of India (DCGI) on January 3 granted restricted emergency use authorisation (EUA) for two COVID-19 vaccines – Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield.
Developed by Bharat Biotech, Covaxin – is India’s first indigenous vaccine against COVID-19, the disease caused by the novel coronavirus.
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The approval came a day after the COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) reportedly recommended grating emergency use authorisation for the vaccine developed by Bharat Biotech. The SEC had also recommended speeding up the process of considering indigenous COVID-19 vaccine candidates being developed by SII, Bharat Biotech and Cadila Healthcare.
Here is a timeline of Bharat Biotech’s Covaxin vaccine developement:
> June 30, 2020 – DCGI approves COVAXIN for human trials, making it the country's first domestic vaccine candidate.
> July 3 – A leaked letter by an official at the Indian Council of Medical Research (ICMR) said the agency aims to launch a COVID-19 vaccine by India’s Independence Day on August 15. This, however, led to questions from some health experts about the short timeline.
> July 3 – Bharat Biotech shares its target of producing up to 300 million doses of the vaccine if its trials succeed.
> July 4 - ICMR says its decision to fast-track development of the potential coronavirus vaccine is in line with international standards.
> October 23 – Bharat Biotech says it is in discussions with more than 10 countries that have shown an interest in its vaccine candidate. It says phase-1 and 2 trials have found the vaccine to be safe.
> November 01 – Bharat Biotech says it is planning to launch the vaccine in the second quarter of 2021.
> November 16 – The company says it is starting phase-3 trials.
> November 20 – Bharat Biotech offers Brazil the vaccine and a possible technology-transfer partnership.
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> December 07 – Bharat Biotech seeks emergency use approval for Covaxin.
> December 22 – United States-based drug developer Ocugen Inc. says it has partnered with Bharat Biotech to co-develop the vaccine candidate for the US market.
> January 2 – Experts at India’s drug regulator approve the vaccine “for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains”.
> January 3 - Covaxin and Covishield granted restricted EUA by DCGI.
This restricted use approval paves the way for Indian authorities to start vaccinating the masses. The government has planned vaccination of 25-30 crore people by July, 2021.
As of January 3, India had reported more than 1.03 crore confirmed COVID-19 cases. The death toll from the outbreak in the country stood at 1.49 lakh. While more than 99.27 lakh patients had recovered, 2.49 lakh cases remained ‘active’. Globally, more than 8.4 crore individuals have been infected by the virus and over 18.3 lakh people have died so far.Follow our full COVID-19 coverage here