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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 9: Kerala opposition coalition United Democratic Front on Thursday submitted a roadmap to Prime Minister Narendra Modi for staggered lifting of ongoing lockdown due to COVID-19 pandemic.

The coalition led by leader of opposition Ramesh Chennithala has given a set of recommendations to Modi in this regard, which include those made by an expert committee headed by deputy leader of opposition M K Muneer.

The committee was set up to suggest measures to be taken by the government for smooth transition from lockdown to normalcy.

It listed an eight-point exit strategy for removing lockdown in a staggered approach at a district level, with emphasis on hotspots to avoid further spread of virus and ensure smooth restart of economy.

This approach is tuned to the unique needs of each district and all the districts should also be categorised as per their risk levels, the report said.

The report has also been submitted to chief ministers of all states, former prime minister Manmohan Singh, Congress president Sonia Gandhi, senior Congress leader Rahul Gandhi among others.

The committee recommended that COVID-19 rapid testing must be enhanced across the country and the testing target be widened to 500 tests per one lakh population.

"A step-by-step approach is necessary for each sector along with conditions that need to be considered for each sector," the report said.

"There is a need for a comprehensive economic stimulus package in addition to the ones already announced after considering all the industries," it added.

Washington, Jan 12: The US State Department has described the recent visit of envoys of 15 countries to Jammu and Kashmir as an "important step" but expressed concern over the continued detention of political leaders and restrictions on internet in the region.

Alice Wells, the Acting Assistant Secretary of State for South Asia, tweeted on Saturday that she was "closely following" the visit of the envoys to Kashmir, describing it an "important step".

Wells, who will be visiting India this week, added: "We remain concerned by detention of political leaders and residents and Internet restrictions. We look forward to a return to normalcy."

The group of diplomats made a two-day visit to the Union Territory on Thursday and Friday to see the conditions thereafter Jammu and Kashmir's special constitutional status was removed last August.

While some US politicians and media have criticised the action by Prime Minister Narendra Modi's government, the US has officially appeared to support the abrogation of the Constitution's Article 370 on the special status.

Last October, Wells told the House of Representatives Subcommittee on Asia and the Pacific that the State Department supported the objectives behind it, while not directly mentioning the abrogation.

"The Indian government has argued that its decision on Article 370 was driven by a desire to increase economic development, reduce corruption, and uniformly apply all national laws in Jammu and Kashmir, particularly in regard to women and minorities.

"While we support these objectives, the Department remains concerned about the situation in the Kashmir Valley, where daily life for the nearly eight million residents has been severely impacted since August 5," she had said.

Washington has banked on India's democratic institutions - the judiciary and public debates - being able to steer the country.

Bearing this out, the Supreme Court last week ordered the government to review its decision to shut down the internet in Kashmir, which it declared was a fundamental right, thus taking a step to address Wells's concern.