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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, Apr 15: The Union Health Ministry has identified 170 districts as COVID-19 hotspots and 207 districts as potential hotspots, officials said on Wednesday, reiterating that there has been no community transmission of the disease in the country so far.

Addressing the daily briefing to provide updates on coronavirus situation in the country, Joint Secretary in the Ministry of Health Lav Agarwal said that states have been asked to classify districts which have reported a higher number of cases as hotspots, the districts where cases have been reported as non-hotspots, and green zones where no cases have been reported.

"Hotspots are those districts which are reporting more number of cases or where the rate of growth of COVID-19 cases is high," Agarwal said, adding a detailed direction has been issued to states stating consolidated efforts are required to utilise this period of lockdown to curb the spread of the virus.

"Cabinet secretary held a video conference today with all chief secretaries, DGPs, health secretaries, collectors, SPs, municipal commissioners and CMOs where hotspots were discussed and orientation on field level implementation of containment strategy was given.

"They were told about large outbreak containment strategies, cluster containment strategies. Delineation of buffer and containment zone, parameter mapping, defining of entry and exit points were also discussed in detail," he said.

The joint secretary said movement of people will not be allowed in containment zones except for those related with essential services and special teams will search for new cases and samples will be collected and tested as per sampling criteria.

The officials said that health facilities in buffer zone outside the containment zone will be oriented and people facing SARI and influenza-like symptoms will be tested there.

"Special teams have been formed which will work in containment zone and do contact tracing and house-to-house surveys. Cases of fever, cough and breathlessness will be identified in the survey and requisite action will be taken as per protocol," Agarwal said, adding that there has been no community transmissions so far but some local outbreaks.

The total number of COVID-19 cases in India has risen to 11,439 with 1,076 fresh cases reported in the last 24 hours while the death toll stands at 377, the ministry official said.