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
March 28,2020

Amaravati, Mar 28: The state governments of Andhra Pradesh and Karnataka carried out a joint quarantine operation to help over a thousand migrant labourers from various districts of Andhra Pradesh.
The Andhra Pradesh administration received the information that 1,334 migrant labourers were trying to return to the state after obtaining passes from the Deputy Director of Fisheries in Mangalore, Karnataka.
The labourers, according to a press release by the Andhra Pradesh government, were headed towards the Nangili Toll Plaza in Kolar district, from where they would enter the state to return to their native places.
"The Chittoor Collector, Superintendent of Police and Sub-Collector rushed to the spot to coordinate with their counterparts from Kolar, Karnataka. The migrant workers were not permitted to enter AP due to the lockdown and the guidelines of the Union as well as state government," according to the release.
Instead, both the governments decided to initiate a joint quarantine operation in Kolar while taking precautionary measures to ensure that none of the labourers are carriers of the COVID-19 infection.
The Andhra government also reassured the Kolar administration that it will provide doctors, healthcare and all other facilities. It has also issued directions for logistical support, food, water, transport to take the labourers to quarantine facility, and medical team, consisting of 12 doctors, 22 supervisors and other staff, to be provided.
While the Prime Minister had imposed a nationwide lockdown, including the suspension of inter-state travel to prevent the spread of coronavirus, migrant workers and labourers around the country have started returning back to their native places fearing joblessness and cash crunch.
Andhra Pradesh as of Saturday 9:30 am, had 14 confirmed cases of coronavirus while Karnataka's count stood at 55, according to the Ministry of Health and Family Welfare.

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Agencies
June 28,2020

New Delhi, Jun 28: Home Minister Amit Shah on Sunday targeted former Congress President Rahul Gandhi, saying he was indulging in "shallow-minded" politics and making statements that make Pakistan and China happy when soldiers are fighting a spirited battle.

Shah said the government is ready for a discussion in Parliament about the situation from 1962 (when India-China war took place) and it is sad that a former president of a party making statements, which are being celebrated in Pakistan and China.

The Home Minister's comments came during an interview with ANI when he was asked about Rahul's "Surrender (Prime Minister Narendra) Modi" remarks while criticising the BJP-led government on India-China border row.

Rahul has been consistent in his criticism of the government on the handling of both Covid-19 situation and India-China border row, which escalated into a "violent face-off" earlier this month in which 20 Indian soldiers were killed.

"Let there be a robust debate in Parliament. Let us have one. Let us discuss from 1962. Nobody is scared of debate. But one should not make a statement that makes Pakistan and China happy when the soldiers are fighting a spirited battle and the government is taking strong steps," he said.

Asked whether India can handle the anti-India propaganda unleashed by Rahul's 'Surrender Modi' hashtag, he said the government is capable of handling it but it is a matter of introspection for the former Congress president and his party that their remarks are being used against the country.

Modi's remarks at an all-party meeting that no one has intruded into Indian territory triggered a controversy with a section arguing that it went against the previous statement of External Affairs Minister S Jaishankar.

Claiming that he could not advise Rahul as it is Congress' job to do so, he said the government has fought Covid-19 well but some people have a twisted way of seeing things. He said India fought well against Covid-19 and the statistics will speak for itself as it is much better compared to the world.

Shah said under Modi's leadership, India is going to win both the battles -- Covid-19 and India-China border row.

The Home Minister also refused to be drawn into a question on whether Chinese soldiers are holding on to Indian territory on the border at present, saying the government is doing enough to address border row with China.

"I don't want to do anything that goes against my primary aim of this interview (to highlight the steps taken to fight Covid-19 pandemic in Delhi) and create headlines that keep citizens further in fear," Shah said.

When pointed out that people are also in panic due to the border situation, he said the government has taken steps to address the situation and at an appropriate time he would make comments, if needed.

Asked about his tweets on Emergency, which was targeted by Congress asking whether there is democracy in the BJP, he countered it saying that BJP has presidents L K Advani followed by Rajnath Singh, Nitin Gadkari, Rajnath again, himself and now J P Nadda.

"After Indira-ji, was there any Congress President from outside Gandhi family? What democracy do they talk about? I did not do any politics during Covid-19. You look at my tweets of the past 10 years. Every June 25, I give a statement," he said.

"Emergency should be remembered by people as it attacked the roots of our democracy. No one should ever forget it. There should be awareness about it. It is not about a party but about the attack on the country's democracy," he said.

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Agencies
May 27,2020

Global health experts on Wednesday said novel coronavirus is here to stay for more than a year and called for aggressive testing to prevent its spread.

In an interaction with Congress leader Rahul Gandhi, health experts Professor Ashish Jha and Professor Johan Giesecke talked about the COVID-19 pandemic as part of the series being aired on Congress social media channels.

While Jha exuded confidence that a vaccine will be available in a year's time, Prof Giesecke said India should practice a lockdown that is as 'soft' as possible, as a severe lockdown will ruin its economy very quickly.

"When the economy is opened up after lockdown, you have to create confidence among people," Harvard health expert Ashish Jha told Gandhi.

Jha is a professor of Global Health at TH Chan School of Public Health and Director, Harvard Global Health institute.

He said coronavirus is a '12-18 months' problem and the world is not going to be free of this till 2021.

The expert also called for the need for aggressive testing strategy for high-risk areas.

Gandhi, while interacting with the experts, said life is going to change post COVID-19.

"If 9/11 was a new chapter, this will be a new book," he remarked.

Professor Johan Giesecke, former chief scientist, European Centre for Disease Prevention and Control said India should have a 'soft lockdown'.

"The situation that India is in, I think, you should have a soft lockdown, as soft as possible," he said.

"I think for India, you will ruin your economy very quickly if you have a severe lockdown. It is better, skip the lockdown, take care of the old and the frail...," he noted.

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