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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.

Mumbai, Mar 22: The total number of coronavirus positive patients in Maharashtra has risen to 74 with 10 more positive cases reported in the last 24 hours, officials said.

Of the 10 new cases, 6 are in Mumbai and 4 in Pune, they said on Sunday.

Earlier this week, a Covid-19 patient died in Mumbai.

Mar 4: Twenty-one Italian tourists and three Indian tour operators have been sent to an ITBP quarantine facility in Delhi on Tuesday for suspected coronavirus exposure, official sources said.

Health Ministry sources said these foreigners, 13 women and eight men, were in the same group of which an Italian and his wife have tested positive in Rajasthan capital Jaipur.

“His (Italian in Jaipur) condition is stable,” a source said.

Three Indians, who were accompanying this Italian group as tour operators, have also been sent to the ITBP facility in Chhawla area of south-west Delhi, they said.

All these people, staying at a five-star hotel in south Delhi, have been put in “preventive isolation” at the ITBP camp and their samples will be taken on Wednesday, sources said.

The centre already has 112 people, 76 Indians and 36 foreigners, since February 27 after they were evacuated by an IAF plane from Wuhan in China, the epicentre of the coronavirus.

The first samples of these 112 people had tested negative when reports came in last week.