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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.

New Delhi, Jun 4: CSIR Director-General Shekhar Mande said on Thursday that the World Health Organisation's (WHO) decision to halt hydroxychloroquine (HCQ) drug trial was taken in haste and the global body should have actually analysed the data before making the decision.

"I firmly believe that WHO decision was taken in haste it was a kind of knee jerk reaction they should have actually analyse the data on their own before temporarily suspend the trials that is my personal opinion," Mande said.

India's nodal government agency ICMR (Indian Council of Medical Research) overseeing the country's response to the coronavirus pandemic last month wrote to the WHO citing differences in dosage standards between Indian and international trials that could explain the efficacy issues of HCQ in treating COVID-19 patients.

In addition, Dr Sheela Godbole, National Coordinator of the WHO-India Solidarity Trial and Head of the Division of Epidemiology, ICMR-National AIDS Research Institute also wrote a letter via an email to Dr Soumya Swaminathan, Chief Scientist at World Health Organisation.

In a letter, Dr Godbole stated: "There was no reason to suspend the trial for safety concern," attributing it to the current RECOVERY data which differs significantly from the non-randomised assessment by Mehra et al, a scientific paper.

Referring to the letter, the CSIR head said, "We don't know what actually happened behind the scenes but the hypothesis is that because of the paper published in Lancet. It is a very well known journal and if Lancet has done due vigilance in publishing the paper. 

Therefore, the WHO thought the paper's findings are right that's why WHO hold based on what is published on Lancet. The WHO shouldn't have accepted it immediately this should have taken their own due vigilance to find out that study is right or not."

DG CSIR said because there is a global outcry it must have put pressure on both Lancet as well as WHO and both of them now retracted from their original position. "WHO has started a trial again and Lancet has put an expression of concern on their website both of these are very welcome development for science," he said.

"So I am pretty sure that Lancet would have published the reports only after seeing somewhere the drug failed to work," Mande said.

Kochi, Jan 22: The Left front government in Kerala on Monday decided to inform the Centre it would not cooperate with the updation of the NPR, saying there were fears among the public about the process and it has the "Constitutional responsibility" to alleviate them and ensure law and order.

A special cabinet meeting, chaired by Chief Minister Pinarayi Vijayan here, decided to inform the Registrar General and Census Commissioner under the Union Home Ministry that it was unable to cooperate with anything with regard to the updation of the NPR.

"The decision was taken as it was the Constitutional responsibility of the government to alleviate the fears of general public and ensure law and order situation in the state," a Chief Minister's Office release said.

However, the state would fully cooperate with the census procedures, it said.

The LDF government, which has been on a warpath against the Centre over the Citizenship Amendment Act, has last month stayed all activities related to updation of NPR, considering 'apprehensions' of public that it would lead to NRC in the wake of the controversial CAA.

"As the NPR is a process that leads to the National Register of Citizens (NRC), there is a sense of fear among the people that its implementation could lead to widespread insecurity", the CMO release said on Monday.

The experience of the state which had already compiled the NRC was an example for this, it added, in apparent reference to Assam.

Kerala had already stopped all procedures regarding the NPR updation, the release said adding there was also a report of the state police that the if the government went ahead with the procedures, it would adversely impact the law and order situation.

The district collectors have also informed the government that the Census procedures would be affected if the updation of the NPR was done along with it, the CMO release said.

The CPI(M)-led LDF government had recently convened a meeting of political parties and socio-religious organisations here on December 29 in the wake of the concerns among people in various stratas of the society, it said.

A special assembly session was convened and a resolution was passed requesting the Centre not to implement the CAA and the government had also approached the apex court against the law, it added.