Bharat Biotech announces India's first COVID-19 vaccine candidate 'COVAXIN' with DCGI approval for human clinical trials

News Network
June 30, 2020

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.

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News Network
January 21,2020

Amaravati, Jan 21: Telugu Desam Party president N Chandrababu Naidu and at least 17 MLAs of his party were taken in police custody late on Monday as they tried to conduct a foot march from the state assembly to nearby Mandadam village in violation of prohibitory orders.

TDP leaders started off on the march after staging a sit-in near the assembly main entrance following the suspension of 17 MLAs from the House for the day.

They were protesting the AP Decentralisation and Inclusive Development of All Regions Bill, 2020, that was passed by the assembly, enabling the establishment of three capitals for the state.

The TDP leaders were taken to the Mangalagiri police station.

Meanwhile, tensions prevailed at the Jana Sena Party headquarters at Mangalagiri as police prevented its president Pawan Kalyan from proceeding to the Amaravati region to speak to protesters fighting for the retention of only one capital for the state.

DIG Kanti Rana Tata and other senior police officials reached the Sena office and blocked the exit of Kalyan and political affairs committee chairman Nadendla Manohar, resulting in an argument.

Kalyan asked how could police impose restrictions within his own office.

Scores of Sena workers gathered outside the office even as a large posse of police was posted to thwart Kalyan and other leaders' plans.

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News Network
February 9,2020

Mumbai, Feb 9: Given the slow progress on the ongoing Rs 38,000-crore capacity expansion at the four largest metro airports, and also the surging traffic, the snaky queues will continue at least till 2023, warns a report.

The four largest airports -- New Delhi, Mumbai, Bengaluru and Hyderabad -- handle more than half of the traffic and are operating at 130 per cent of their installed capacity. These airports are under a record Rs 38,000-crore capex but the capacity will not come up before end-2023, says a Crisil report.

“With the dip in traffic growth largely behind, we expect congestion at the top four airports of New Delhi, Mumbai, Bengaluru and Hyderabad, which handle more than half of the load, to continue till about FY23,” says the report.

Already these airports are operating at over 130 percent of installed capacity, and the ongoing healthy traffic growth this operating rate is expected to rise further in the next 12 months.

“Operationalising of capacities in the following two fiscals will bring down utilisation levels albeit still high at over 90 per cent by fiscal 2023 and that is despite an unprecedented Rs 38,000 crore capex being undertaken by the operators of these airports over five fiscals 2020-24,” says the report.

Despite this unprecedented capex that is debt-funded, ratings are likely to be stable given the strong cash flows expected due to healthy traffic growth, low project risks associated with the capex and improving regulatory environment, notes the report.

“Capacity at these four airports will increase a cumulative 65 per cent to 228 million annually (from 138 million now) by fiscal 2023. However, traffic is expected to grow strong at up to 10 per cent per annum over the same period. Since additional capacities will become operational in phases only by fiscal 2023, high passenger growth will add to congestion till then,” warn the report.

High utilisation will ride on pent-up demand (accumulated in 2019 as traffic was impacted with the grounding of Jet Airways) and one-off issues with new aircraft of certain airlines.

Further impetus will also come from improving connectivity to lower-tier cities and reducing fare difference between air and rail. Increasing footfalls at airports provide a leg-up to non-aero streams such as advertising, rentals, food and beverage and parking, which comprise around half of the revenue of airports already.

These are expected to grow strongly at over 10-12 per cent, also supported by higher monetisation avenue coming along with current capex. The other half of revenue (aero revenue) is an entitlement approved by the regulator, providing a pre-determined, fixed return over the asset base and a pass-through of costs.

Aero revenue is also expected to get a bump up during fiscals 2022-24, when a new tariff order for airports is likely. Overall aggregate cash flows are likely to double by fiscal 2024 and provide a healthy cushion against servicing of debt contracted for capex, the report concludes.

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Agencies
January 12,2020

New Delhi, Jan 12: A fact-finding committee of the Congress on the JNU violence on Sunday said the January 5 attack inside the university campus was "state-sponsored" and recommended Vice Chancellor M Jagadesh Kumar be dismissed and criminal investigation initiated against him.

The Congress had appointed a four-member fact-finding committee to carry out a detailed inquiry into the violence at the Jawaharlal Nehru University (JNU).

Sushmita Dev, member of the committee, said the committee recommended that Kumar should be dismissed immediately and all the appointments in faculty should be probed and independent inquiry should take place.

"Criminal investigation must take place against the VC and faculty members and the security company," the Mahila Congress chief said.

"It is clear that the attack on JNU campus was state-sponsored," Dev said.

She also demanded a complete rollback of the JNU fee hike.

The other members of the fact-finding committee are Hibi Eden, MP and former NSUI president, Syed Naseer Hussain, MP and former president of JNU NSUI and Amrita Dhawan, a former NSUI president and ex-DUSU president.

On January 5 night, masked people armed with rods and sticks stormed the JNU campus and assaulted students and faculty members, and vandalised property, leaving several people injured.

Leftist outfits and the RSS-affiliated Akhil Bharatiya Vidyarthi Parishad (ABVP) blamed each other for the violence.

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