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 4,2020

New Delhi, Aug 4: Over 50 per cent of COVID-19 deaths in India have taken place among people aged 60 years and above and 37 per cent deaths have been reported among patients in the age group of 45 to 60 years, Health Ministry said on Tuesday.

Addressing a press conference, Rajesh Bhushan, Secretary, Health Ministry said that 11 per cent COVID-19 deaths took place in the age group of 26 to 44.

The 18 to 25 age group and those below 18 years reported one per cent deaths each.
"Currently, 5,86,298 active COVID-19 cases are in India and over 12 lakh people have recovered.

50 per cent deaths due to COVID19 have taken place among the age group of 60 years or above and 37 per cent deaths took place in the age group between 45 to 60 years," Bhushan said.

"A total of 11 per cent COVID-19 deaths took place in the age group of 26 to 44. Only 1 per cent in 18 to 25 age group and 1 per cent in below the age of 18 years," he added.

Bhushan said that 68 per cent of COVID-19 deaths have been reported among male patients and 32 per cent among female patients which is broadly in line with the global scenario.

The number of recovered COVID-19 patients in India is increasing daily and is now over double the number of active cases.

Bhushan said that the case fatality rate (CFR) is lowest since the first lockdown.

"More than 2 crore COVID-19 tests have been conducted, including more than 6.6 lakh tests in the last 24 hours. Recovered cases are now double of the active cases. 

The case fatality rate (CFR) is lowest since the first lockdown," he said
"This is the first time after the first lockdown that the fatality rate is at the lowest, at 2.10 per cent. The fatality rate has seen a progressive decline and it is continuing, which is a good sign," he added.

According to the World Health Organisation, CFR is a measure of the severity of a disease and is defined as the proportion of reported cases of a specified disease or condition which are fatal within a specified time.

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News Network
April 15,2020

New Delhi, Apr 15: Tablighi Jamaat leader Maulana Saad Kandhalvi has been booked for culpable homicide after some of the attendees of the religious congregation died due to coronavirus, police said on Wednesday.

Kandhalvi had organised the religious gathering at Nizamuddin Markaz last month against the social distancing protocol imposed by the Centre to curb the spread of the deadly disease.

An FIR was registered against the cleric on March 31 at Crime Branch police station on a complaint of the Station House Officer of Nizamuddin.

He was earlier booked for holding the event, police said.

“After several attendees of the Tablighi Jamaat event succumbed to coronavirus, we added IPC section 304 (culpable homicide not amounting to murder) in the FIR against the leader, a police official said.

Some foreigners who attended the event have also been booked for violation of visa norms.

In an audio message, Kandhalvi had said that he was exercising self-quarantine after several hundreds who visited the Tablighi Jamaat congregation at Nizamudddin Markaz tested positive for coronavirus.

The FIR registered against the Tablighi Jamaat event says that the Delhi Police contacted the authorities of Nizamuddin Markaz on March 21 and reminded them of the government order which prohibited any political or religious gathering of more than 50 people.

It says that despite repeated efforts, the event organisers failed to inform the health department or any other government agency about the huge gathering inside the Markaz and deliberately disobeyed government orders.

“The sub district magistrate of Defence Colony inspected the premises several times and found that around 1,300 people, including foreign nationals, were residing there without maintaining social distance. It was also found that there were no arrangements of hand sanitizers and face masks,” the FIR adds.

The Nizamudddin centre, attended by thousands, turned out to be a hotspot for spread of coronavirus not only in the national capital, but the entire country.

More than 25,500 Tablighi members and their contacts have been quarantined in the country after the Centre and the state governments conducted a "mega operation" to identify them.

At least 9,000 people participated in the religious congregation in Nizamuddin. Later, many of the attendees travelled to various parts of the country.

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Agencies
May 19,2020

Lucknow, May 19: The administration of the Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI) has ordered a probe into the cardiac procedure conducted on a corona positive patient in the hospital.

The patient underwent a cardiac procedure without being tested for corona before the surgery. He later tested positive for COVID-19, leading to panic among the staff and other patients.

The medical staff that came in contact with the patient were quarantined on Monday while the area was sanitized.

As per orders from the State Medical Education Department, even in emergency cases, patients are to be screened for Covid-19 before procedures are done.

According to the SGPGI administration, the incident took place late on Sunday night.

In an official statement, director, Prof R.K. Dhiman said, "The 63-year-old patient was a case of complete cardiac blockage and needed an urgent temporary pacemaker. The patient was admitted to the holding area of the institute and later shifted to the MICU for permanent pace making."

He said that when the patient's corona status was found to be positive on the Hospital Information System, she was shifted to the Rajdhani COVID Hospital.

The Director said, "Though the involved areas have been sanitized and healthcare workers were quarantined as per protocol, a probe has been ordered to investigate the lapses."

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