Bharat Biotech's Covaxin has been approved for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode

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Covishield, Covaxin approved in India. (Credit: Pete Linforth from Pixabay)

India’s Central Drugs Standards Control Organisation (CDSCO) approved Covid-19 vaccines Covishield and Covaxin for restricted emergency use in India.

Oxford-AstraZeneca’s Covid-19 vaccine Covishield is manufactured by Serum Institute of India, and Covaxin is developed by the Indian biotechnology firm Bharat Biotech.

The CDSCO approval is based on the recommendation of the Subject Expert Committee (SEC).

Bharat Biotech’s Covaxin has been approved for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specifically in the context of infection by mutant strains.

In early December 2020, AstraZeneca announced positive results from an interim analysis of Phase 3 clinical trials of its Covid-19 vaccine candidate, in the UK and Brazil.

According to the company, vaccine was well tolerated, with no confirmed serious safety events, and showed an average of 70.42% efficacy in preventing symptomatic Covid-19.

DCGI approves clinical study of Zydus Cadila’s DNA-based vaccine

Furthermore, the Drugs Controller General of India (DCGI) has approved ZyCoV-D, a DNA-based Covid-19 vaccine candidate developed by Zydus Cadila, to conduct the Phase 3 clinical trials.

The National Biopharma Mission (NBM), under the aegis of BIRAC and the Government of India’s Department of Biotechnology (DBT) is supporting the development of ZyCoV-D.

Zydus Cadila has completed Phase 1/2 clinical trials of ZyCoV-D, in more than 1,000 participants from India. The interim data showed positive safety and immunogenicity results when three doses of vaccine administered intradermally.

The Phase 3 clinical trial is planned to be conducted in 26,000 Indian participants.

DBT secretary and BIRAC chairperson Renu Swarup said: “The Department of Biotechnology, Government of India has partnered with Zydus Cadila, to address the need for accelerated development of an indigenous vaccine for Covid-19.

“The partnership exemplifies that such research endeavours demonstrate the Government’s focus on creating an ecosystem that nurtures and encourages new product innovation with societal relevance.

“The establishment of the Nation’s first DNA vaccine platform is an important milestone for Atma Nirbhar Bharat and a big leap forward for Indian scientific research.”