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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, Jun 25: The Supreme Court on Thursday asked the Centre and the CBSE to issue fresh notification in connection with Class 12 exams, clarifying the option between internal assessment and exams later.

The observation from the top court after it was informed that the CBSE has decided to cancel the remaining board exams for Class 10 and Class 12.

A bench comprising Justices AM Khanwilkar, Dinesh Maheshwari and Sanjiv Khanna asked the Centre to clarify the issue of taking the option between internal assessment and exams later.

"Clarify the date of results," said the bench, noting that the CBSE will have to submit a fresh draft notification cancelling class 12 Board exams and affidavit on Friday morning, before the top court continues to hear the matter again at 10.30 a.m.

The apex court also sought clarity on the beginning of the new academic year.

It told Solicitor General Tushar Mehta, representing the Centre, that the CBSE is willing to conduct exams when the situation is conducive, but this may vary from state to state. "Will the decision be taken by a central authority or will the state government take the decision? How are you going to deal with that situation?"

Mehta replied that the decision must be taken according to the situation. To this, the bench said should not the solution be pan-India?

"You have not said when you will decide on this issue, and when you will take stock of these things. Some time frame will have to be given," noted the bench.

Continuing its queries, the bench said: "What about state regional board exams... the CBSE does not hold all the exams. The state Board is also there."

Mehta replied that the instructions from the controller of examinations are that exams are controlled centrally. "State boards assist the CBSE," he replied.

The bench observed that the government should modify the draft notification and include the state board issue. "Clear the stand that decision will be taken at the central level and not at the state level... other courses will have to be delayed till CBSE exam results come out," it said.

Mehta replied the assessment results will be published now, and if a student wants to opt to give the exam, then that will be conducted later. The top court asked Mehta to bring this on record and redraft the notification.