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
April 23,2020

More and more Indians have become better prepared in the last one month, as far as stocking of their ration, medicine or money is concerned, according to the IANS-CVoter COVID-19 Tracker.

With the second leg of the lockdown half way through and Prime Minister Narendra Modi saying it's a long haul, 57.2% respondents said they have less than three weeks of stock while 43.3% said they have a stock that will last beyond that

However, if one breaks into weeks, most respondents said they are prepared for a week's time. 24.5% respondents said they have ration, medicine or money to last a week. This is closely followed by 21.9 % respondents saying they are ready for a month.

Meanwhile, 20.4 % said they are ready for a couple of weeks. There are 15.8 % who said they are ready for more than a month with food, ration and medicine. A tiny 5.6 % said they are ready with three weeks of stock.

However, there is 12.3% who still seem to live on the edge with less than a week's preparation.

But, the biggest takeaway from the IANS-CVoter COVID-19 Tracker is that in the last one month, a massive segment of society realised that the fight is long and the preparation should also be to last that long.

o put things into context, on March 16 when the tracker started, a whopping 77.1% said they have stock to last for less than a week. More than a month later on April 21, that number jumped to just 12.3%, which essentially means, people have become better prepared for a long-hauled lockdown period.

Similarly, on April 21, a sizable 21.9% respondents claimed they are ready with ration and medicine that will last them a month. On March 16, not even one respondent could claim they have a month's stock. In fact till March 22, just ahead of the announcement of the first lockdown, no respondent the IANS-CVoter tracker said that they have a month's preparation.

Similarly, when the tracker started, 9.9% said they simply ‘don't know'. As on April 21, that number is a big zero.

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News Network
April 23,2020

New Delhi, Apr 23: The entire Muslim community cannot be held responsible for one group's "crime", Minority Affairs Minister Mukhtar Abbas Naqvi said on Thursday while reacting to instances of Muslims being blamed for the spurt in COVID-19 cases after Tablighi Jamaat congregation here, and asserted that most of the minority community members have condemned the group's action.

In an interview to news agency, Naqvi also expressed confidence that Muslims will abide by lockdown guidelines during the holy month of Ramzan.

He said across the India, imams, Ulema and Muslim organizations have unanimously decided that during Ramzan (the Islamic holy month), Muslims will not congregate in mosques, religious places and perform all rituals like 'Iftaar' (breaking of fast) and 'taraweeh' (special prayers) at home keeping in mind social distancing norms.

Naqvi said he has spoken with state waqf board officials, social and religious leaders, imams on adherence to the lockdown and social distancing guidelines during the Ramzan month starting Friday or Saturday evening and they have begun creating awareness among the people.

Asked about some people blaming Muslims for the spread of the pandemic after a large number of cases were found linked to the Tablighi Jamaat event at Nizamudddin here, Naqvi said the whole community cannot be held responsible for the "crime" of one organisation or one person.

"Whatever that organisation did, criminal negligence or crime...most Muslims have strongly reacted to it, condemned it and called for action against it. Entire community cannot be held responsible for one person or one organisation's crime," he asserted, adding that this has always been India's culture.

Last week, the Union Health Ministry had said 29.8 per cent of the total COVID-19 cases — 4,291 out of 14,378 COVID-19 infections — in the country were linked to the Tablighi Jamaat congregation in March at the group's headquarters in Delhi following which some sections of the society severely criticised Muslims, and blamed them for the spread of the pandemic in the country.

Naqvi's comments also assume significance in view of the 57-member prominent international Mulim grouping, Organisation of Islamic Cooperation (OIC), asking India to take "urgent steps" to protect the rights of its minority Muslim community and stop the incidents of "Islamophobia" in the country.

Hitting out at the OIC, the minister had said the country is "heaven for Muslims" and those trying to vitiate the atmosphere of prosperity cannot be friends of Indian Muslims.

Naqvi said those targeting Muslims are few isolated people who are trying to spread "misinformation" and "we should be united and isolate such elements".

On the COVID-19 lockdown restrictions during Ramzan, Naqvi said no Muslim wants to stay away from mosques during the holy month, but everyone has resolved to win this battle against coronavirus.

During this month, everyone should pray to God that not only India but also the entire world is freed from this COVID-19 pandemic, he said.

Asked whether Muslims have followed lockdown and social distancing guidelines till now, Naqvi said, "absolutely, the entire country is standing united in this fight against coronavirus."

"When Prime Minister Narendra Modi had appealed to people with folded hands, he had appealed to 130 crore Indians, it was not based on caste or religion. And everybody responded to his appeal and acted on it," he said.

People have faith that whatever Prime Minister Modi does is for the health and safety of the people, Naqvi said.

Asked about the role of the Opposition in the fight against COVID-19 and Congress chief Sonia Gandhi and Rahul Gandhi's suggestions, Naqvi said,"some people have criticized, but that is their habit, we don't take any offence to it."

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Agencies
May 23,2020

New Delhi, May 23: The nationwide lockdown will no longer help India in its fight against COVID-19, and in its place community-driven containment, isolation and quarantine strategies have to be brought into play, leading virologist Shahid Jameel said.

The recipient of Shanti Swarup Bhatnagar Prize for Science and Technology also stressed that testing should be carried out vigorously to identify coronavirus hotspots and isolate those areas.

"Our current testing rate at 1,744 tests per million population is one of the lowest in the world. We should deploy both antibody tests and confirmatory PCR tests. This will tell us about pockets of ongoing infection and past (recovered) infection. This will provide data to open up gradually and let economic activity resume," Jameel told PTI in an interview.

He stressed that testing has to be dynamic to continuously monitor red, orange and green zones and change these based on that data.

About community transmission of COVID-19 in India, Jameel said the country reached that stage long ago.

"We reached community transmission a long time ago. It's just that the health authorities are not admitting it. Even ICMR's own study of SARI (severe acute respiratory illness) showed that about 40 per cent of those who tested positive for SARS-CoV-2 did not have any history of overseas travel or contact to a known case. If this is not community transmission, then what is?" he posed.

Lockdown bought India time in its fight against coronavirus, but continuing it is unlikely to yield any further dividend, Jameel said.

"Instead, community-driven local lockdowns, isolations and quarantines have to come into play. Building trust is most important so that people follow rules. A public health problem cannot be dealt with as a law-and-order problem."

The nationwide lockdown, initially imposed from March 25 to April 14, has been extended thrice and will continue at least till May 31. The virus has claimed 3,720 lives and infected over 1.25 lakh people in the country so far.

Jameel has expertise in the fields of molecular biology, infectious diseases, and biotechnology. He is the CEO of Wellcome Trust/Department of Biotechnology's India Alliance and is best known for extensive research in Hepatitis E virus and HIV.

He said COVID-19 will eventually be controlled through herd immunity, which is acquired in two ways – when a sufficient fraction of the population gets infected and recovers, and with vaccination.

"It is estimated that for SARS-CoV-2 at least 60 per cent of the population would have to be infected and recovered, or vaccinated. This will happen over the course of the next few years," Jameel said.

Herd immunity is reached when the majority of a population becomes immune to an infectious disease, either because they have become infected and recovered, or through vaccination. When that happens, the disease is less likely to spread to people who aren't immune, because there just aren't enough infectious carriers.

"India has 1.38 billion people, a population density of about 400/sq km and a healthcare system ranked at 143 in the world. If we allow 60 per cent people to get infected quickly in the hopes of herd immunity, that would mean 830 million infections," Jameel said.

"If 15 per cent need hospitalization that means about 125 million isolation beds (we have 0.3 million). If five per cent need oxygen and ventilatory support, this amounts to about 42 million oxygen support and ICU beds; we have 0.1 million oxygen support beds and 34,000 ICU beds. This would overwhelm the healthcare system causing mayhem," he said.

Jameel said if the population level mortality is 0.5 per cent that would mean 40 lakh deaths. "Are we prepared to pay this price for herd immunity in the short term? Clearly not," he said.

He said it is unlikely that a vaccine would be available by the end of the year.

"Even then, we don't know yet how long it would give protection – weeks, months, one year, a few years? I don't think we will return to pre-coronavirus days for at least the next 3-5 years. This is also a chance to evaluate if we want to return to those unsustainable, environment-damaging ways. COVID-19 is a timely warning to reform our way of living," he said.

Jameel said it is hard to predict but plausible that COVID-19 would return in second or third wave.

"Later waves come when we don't understand the disease and become lax. A comparison to Spanish Flu is not entirely valid because in 1918 no one knew what caused it. No one had seen a virus till the mid-1930s as the electron microscope needed to view those was invented in 1931," he said.

"Today we know a lot more about the pathogen, its genetic makeup, how it transmits and how to prevent it. We need to be sensible and follow expert advice," he said.

If there is any scientific evidence linking deforestation, rapid urbanisation, climate change with pandemics like COVID-19, he said zoonotic viruses -- those that jump from animals to humans -- happen so when wild animal–human contacts increase.

"Deforestation destroys animal habitats bringing them closer to humans. When you cut forests, bats come to roost on trees closer to human habitations. Their viruses in secretions/stool get transmitted to domestic animals and on to humans. This happened clearly with Nipah virus outbreak in Malaysia in 1997-98 from fruit bats to pigs to humans," he said.

"COVID-19 possibly arose in wet animal markets due to dietary habits that bring all kinds of live and dead wild animals in close contact with humans," Jameel added.

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