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Hyderabad, Jun 30: Hyderabad-based Bharat Biotech announced that it has successfully developed Covaxin, India's first vaccine candidate for Covid-19, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.

The indigenous, inactivated vaccine developed and manufactured in the company's Bio-Safety Level 3 (BSL-3) High Containment facility located in Genome Valley, Hyderabad.

Announcing the vaccine development milestone, Dr Krishna Ella, Chairman and Managing Director said: "We are proud to announce COVAXIN, India's first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine."

Dr Ella added, "The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform."
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.

Speaking about Bharat Biotech's prowess, Suchitra Ella, Joint Managing Director said, "Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic."
"Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India's strength in handling future pandemics," she added.

Bharat Biotech's track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.

New Delhi, May 30: The Congress on Friday described the first year of the Modi government as a "year of disappointment, disastrous management and diabolical pain".

Congress leader K C Venugopal said the six years of the Modi dispensation have seen fraying of bonds of empathy, fraternity and brotherhood with increase in acts of communal and sectarian violence.

Congress chief spokesperson Randeep Surjewala said that at the end of six years, it appears the Modi government is at war with its people and is inflicting wounds on them, instead of healing them.

"It is inflicting wounds on Mother India," he said.

"This government is trying to fill coffers of the select rich and is inflicting pain on the poor," Surjewala said.

On the BJP's charge of the Congress playing politics over the COVID-19 crisis, Venugopal said the opposition party did not indulge in any politics and gave suggestions instead.

"Being a responsible opposition, it is our duty to raise the problems faced by the common people. As opposition, we highlighted the failures of the government," he said.

Venugopal said the government "is totally insensitive" to the plight of migrant labourers and farmers.

Surjewala also demanded that a virtual session of Parliament be convened immediately to discuss pressing issues and the due process be set in motion for holding of meetings of various parliamentary committees.

Modi and his cabinet had taken oath on this day last year for a second term in office.