COVID-19 | Venkaiah Naidu updated on status of Covaxin

Vice President lauds ICMR and Bharat Biotech collaboration for COVID vaccine

December 26, 2020 12:07 am | Updated 09:17 am IST - HYDERABAD

Vice President M. Venkaiah Naidu with Bharat Biotech CMD Krishna Ella and Joint MD Suchitra Ella at his residence in Hyderabad.

Vice President M. Venkaiah Naidu with Bharat Biotech CMD Krishna Ella and Joint MD Suchitra Ella at his residence in Hyderabad.

Bharat Biotech’s senior leadership on Friday called on Vice President M. Venkaiah Naidu and updated him on the status of COVID-19 vaccine candidate Covaxin being developed in collaboration with the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV).

The discussion revolved around the status of the indigenous vaccine and plans to make it available in the country and rest of the world, said an official release on the interaction Mr. Naidu had with Bharat Biotech CMD Krishna Ella and Joint MD Suchitra Ella at his residence in the city.

The Vice President stressed the importance of public private partnership in coming with indigenous world class products. He lauded the collaboration between the ICMR and Bharat Biotech, the release said.

An inactivated vaccine, Covaxin, is being developed and manufactured at Bharat Biotech’s Bio-Safety Level 3 (BSL-3) bio-containment facility in Hyderabad.

Last month, Prime Minister Narendra Modi had visited the company’s facility in Genome Valley here and reviewed the status of Covaxin. Following this, earlier this month, 70 Ambassadors and High Commissioners from several countries visited the facility as part of an initiative of the Ministry of External Affairs (MEA).

Phase III clinical trials

Phase III clinical trials for the vaccine are underway since last month and set to involve about 26,000 volunteers. The company had a few days ago announced the recruitment of 13,000 of the volunteers for the Phase III trials that are being conducted at multiple sites across the country. It is India’s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in the country, the company had said.

Phase I and Phase II clinical trials of Covaxin involved around 1,000 subjects. A pre-print paper on the interim findings of the Phase II trials said the vaccine candidate showed tolerable safety outcomes and enhanced humoral and cell-mediated immune responses.

In Phase I, it produced high levels of neutralising antibodies that remained elevated in all participants three months after the second vaccination.

Though a timeframe pertaining to Phase III trials, receipt of approvals and launch is not clear as yet, the company had recently applied for an emergency use authorisation (EUA). Its application, however, was kept on hold, citing the need for more evidence, by an expert committee of the Drugs Controller General of India (DCGI).

ICMR on Thursday had tweeted, “Data generated from within India underlines impressive safety and immunogenicity profile of Covaxin and sparks Lancet’s interest in publishing them.”

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