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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Agencies
August 2,2020

New Delhi, Aug 2: The Ministry of Health and Family Welfare on Sunday issued fresh guidelines for international passengers coming to India amid the COVID-19 pandemic. The new guidelines will be implemented from 12:01 am on August 8.

The ministry has also asked all passengers to submit a self-declaration form online at least 72 hours before travel.

"All travellers should submit self-declaration form on the on the online portal (www.newdelhiairport.in) at least 72hours before the scheduled travel," the guidelines said.

It also said that those coming to India must give an undertaking that they would undergo mandatory quarantine for 14 days as prescribed by the government. "They should also give an undertaking on the portal that they would undergo mandatory quarantine for 14 days i.e. 7 days paid institutional quarantine at their own cost, followed by 7 days isolation at home with self-monitoring of health," it added.

Giving exemptions in some cases, the guidelines mentioned, "Only for compelling reasons/cases of human distress such as pregnancy, death in the family. Serious illness and parent (s) with children of 10 years or below, home quarantine may be permitted for 14 days."

"If they wish to seek such exemption, they shall apply to the online portal at least 72 hours before boarding. The decision taken by the government as communicated on the online portal will be final," it said further.

The guidelines further said that travellers could request for exemption from institutional quarantine by submitting a negative RT-PCR test report on arrival.

"This test should have been conducted within 96 hours prior to undertaking the journey. The test report should be uploaded on the portal for consideration," it added.

Passengers have also been asked to download the Aarogya Setu app on their mobile phones.

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News Network
February 29,2020

New Delhi, Feb 29: Amid the raging communal violence in the entire north-east Delhi earlier this week, there were people who were trying to save persons and families from the "other community" from the fury of the mobs of their own community.

Naeem Ali Pradhan, 34, from Shiv Vihar, helped at least 7-8 Hindus on the night of February 24 -- when the violence was at its peak-- escape to safer locations. Shiv Vihar is one of the worst affected areas in the violence.

According to Naeem Ali, that night mobs attacked dozens of shops on the road and later tried to enter inside the residential areas.

Suddenly, he spotted a group of youth who were looking hassled and frantically asking for directions.

"I saw them. Thye were Hindus who were trying to escape a mob looking to target them. They had lost their way inside the streets of our colony. I along with other Muslim men escorted them to the nearby Hindu locality," Naeem, who is also a member of the Aman Committee constituted by the Delhi police, told ANI.

"Several shops which were on the roads including some showrooms were attacked by a group. These Hindus were worried as a mob which was on the main road was attacking people. They asked me the address of a colony as they were unable to find their way," Naeem said.

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Agencies
February 11,2020

New Delhi, Feb 11: Senior Delhi Congress leader and national spokesperson of the party Sharmishtha Mukherjee alleged delay in decision making and lack of strategy and unity at the state level for the party's humiliating performance reflected in the Assembly poll results on Tuesday.

Mukherjee, president of Delhi Mahila Congress, stated that it was high time that the party takes some action. She added that she too was responsible for the Congress' poor show.

The Congress is on the verge of drawing blank again in the Assembly polls as all its candidates were way far behind their AAP and BJP opponents on all the 70 seats. In the 2015 Assembly elections too, Congress failed to win any seat.

"We r again decimated in Delhi. Enuf of introspection, time 4 action now. Inordinate delay in decision making at the top, lack of strategy & unity at state level, demotivated workers, no grassroots connect-all r factors. Being part of d system, I too take my share of responsibility (sic)," Mukherjee tweeted as the results came out.

She also accused the BJP of playing divisive politics while crediting Delhi Chief Minister Arvind Kejriwal for playing "smart politics" as the results showed a clean sweep by the AAP to return to power.

"BJP playing divisive politics, Kejriwal playing ‘smart politics’ & what r we doing? Can we honestly say that we’ve done all 2 put our house in order? We r busy capturing Congress whereas other parties are capturing India. If we r 2 survive, time 2 come out of exalted echo chambers! (sic)," she said in another tweet.

The Congress contested the Delhi polls in alliance with the Rashtriya Janta Dal (RJD), fielding candidates on 66 seats and leaving four to its partner.

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