Saturday, 06 March 2021


India approves SII and Bharat Biotech's Covid-19 vaccines, EUA

04 January 2021 | News

Covishield (developed by Oxford University and AstraZeneca) and Bharat Biotech's Covaxin (developed indigenously in collaboration with ICMR and NIV)

Photo Credit: Freepik

Photo Credit: Freepik

The Drug Controller General of India (DCGI) has approved Serum Institute of India (SII) Covishield (developed by Oxford University and AstraZeneca) and Bharat Biotech's Covaxin (developed indigenously in collaboration with ICMR and NIV) for emergency use against coronavirus on Jan 3, 2021. Both firms submitted data on respective clinical trial runs to avail permission for "restricted use". The clinical trials will continue.

Safety immunogenicity data submitted by SII found efficacy was 70.42 per cent. SII had applied for a two full-dose regime about 28 days apart. The Committee of Central Drugs Standard Control Organisation (CDSCO) is yet to announce the dosage and other details of the jab. The company is making 50-60 million doses of the vaccine every month.

The country is now expected to start a massive immunisation programme within weeks with the aim to immunize 300 million of its 1.35 billion population in the first six to eight months of this year.

SII has secured about 50 million doses of the AstraZeneca/Oxford doses, which will be sold to the government at 250 rupees ($3.42) per dose and 1,000 rupees on the private market. According to Serum Institute of India CEO Adar Poonawalla, Serum's Covishield is cheaper than the vaccine developed by Pfizer-BioNTech and its transportation is also easy as compared to Pfizer's vaccine. 

Serum Institute is yet to receive permission from the government to export the vaccine. "We have bilateral relations with Saudi Arabia and some other countries. We have sought permission from the government in this regard. After getting this approval, we will be able to deliver our medicine to more than 50 countries of the world," said Poonawalla.

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