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Bharat Biotech Covid vaccine candidate’s human trials from July

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Hyderabad, June 29 : Leading vaccine maker Bharat Biotech on Monday 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) and will begin its human trials next month.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech”s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, the company said in a statement.

The Drug Controller General of India – Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase I and 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 next month.

“We are proud to announce Covaxin, India”s first indigenous vaccine against Covid-19. The collaboration with the ICMR and the NIV was instrumental in the development of this vaccine. The proactive support and guidance from the CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.

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.

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Earthquake of magnitude 4.1 strikes Jammu and Kashmir

They said while the tremors caused panic among people, there were no reports of any loss of life or injury or damage to property.

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Srinagar, Jan 16 : An earthquake of magnitude 4.1 hit Jammu and Kashmir on Saturday, but there was no report of any damage, officials said.

At 10:01 pm, the earthquake struck at a latitude of 33.03 degrees north and a longitude of 75.93 degrees east — 93 kms east of Katra, they added.

The depth of the earthquake was 10 kms, the officials said.

They said while the tremors caused panic among people, there were no reports of any loss of life or injury or damage to property.

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Covaxin consent form says vax administered without ph-3 trial

The vaccine is first offered to the healthcare workers, frontline workers and those above 50 years of age, followed by the below-50 population with comorbidities, and finally to the remaining population based on disease epidemiology and vaccine availability.

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New Delhi, Jan 16 : Amid the vaccinaton drive against Covid-19, it has emerged that there is a separate consent form for those who are administered the ‘Covaxin‘ vaccine manufactured by Bharat Biotech.

The form says that “In phase-1 and phase-2 clinical trial ‘Covaxin’ has demonstrated the ability to produce antibodies against Covid-19, however the clinical efficacy of Covaxin is yet to be established and it is still being studied in phase-3 clinical trial, hence it is important to appreciate that receiving the vaccine does not mean that the other precautions related to Covid-19 should not be followed.”

The form says that in case of any adverse and serious condition, the receiver will be provided utmost care at the health centre and in case of casuality the compensation will be provided by Bharat Biotech.

“The compensation for serious adverse event will be paid by sponsor BBIL if the SAE is proven to be casually related to the vaccine,” it said.

Serious concerns were raised in certain quarters including by opposition parties and Congress leader Manish Tewari has questioned the efficacy of ‘Covaxin’ while the Prime Minister has warned people not to believe in “rumours”.

The world’s biggest vaccination drive come almost a year after the first coronavirus case was detected in India, and since then the deadly virus has claimed over 1.5 lakh lives and infected one crore people. The first case came to the fore on January 30, 2020 in Kerala.

Two vaccines — the Oxford vaccine ‘Covishield’ manufactured by the Serum Institute of India, and indigenously developed ‘Covaxin’ by Bharat Biotech — will be administered to priority groups. So far, the central government has procured 1.1 crore Covishield and 55 lakh Covaxin vaccines at a cost of Rs 200 and Rs 206 per dose, respectively.

In Delhi, which has 81 vaccination sites, ‘Covaxin’ has been allotted to six Centre-run hospitals while 75 Delhi government and private hospitals will receive ‘Covishield’.

The vaccine is first offered to the healthcare workers, frontline workers and those above 50 years of age, followed by the below-50 population with comorbidities, and finally to the remaining population based on disease epidemiology and vaccine availability.

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Magnitude 6.7 Earthquake Hits Russia-Mongolia Border Region

The quake was at a depth of 10 kilometers

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AN earthquake of magnitude 6.7 struck the Russia-Mongolia Border Region on Tuesday, the GFZ German Research Center for Geosciences said.

The quake was at a depth of 10 kilometers, it added.

The epicenter of the earthquake was registered 277 kilometers southwest of the city of Angarsk, in the Russian Irkutsk region, and 30 kilometers from the Mongolian city of Turt, Russian state-owned news agency Sputnik reported. https://bit.ly/2XtgrJs

There were no immediate reports of damage or victims, the report said.

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