India's first COVID-19 vaccine candidate COVAXIN gets approval for human trials

India's drug control authorities have allowed Bharat Biotech to hold Phase 1 and 2 of clinical human trials after "company submitted results generated from preclinical studies, demonstrating safety and immune response", a statement issued by the firm added.

Bharat Biotech's coronavirus vaccine Covaxin is the first COVID-19 vaccine to get DGCI's (Drug Controller General of India) nod. The company claims it is "India's first vaccine candidate for COVID-19, developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV)".

The human trials of the vaccine - which was developed in collaboration with the National Institute of Virology, IndianCouncil of Medical Research (ICMR) - are likely to begin in July. "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, India".

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.

The company says that the formula; known as Ad5-nCoV, is now limited to use by military personnel, and can not be offered to a broader population without the approval of the Logistics Support Department, the division of the Central Military Commission which approved the military use of the vaccine.

Also, the early data just suggests that the vaccine may work; to completely confirm its efficacy, the shot has to pass through the Phase 3 trial with thousands of volunteers.

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The Chairman and Managing Director of the Bharat Biotech, Dr Krishna Ella said with strong support from the consortia partners and Government, the entire development process was accelerated through national regulatory protocols.

The Hindustan Times reports that the World Health Organization (WHO) says drug makers AstraZeneca and Moderna Incorporated are current front runners in the race to find an effective vaccine for COVID-19. Results from these studies have been promising and show extensive safety and effective immune responses.

In a recent breakthrough, India has finally developed its first indigenous COVID-19 vaccine named COAXING. Therefore, human trials are scheduled to happen in July.

Coronavirus infection has already cost over 16,475 lives in India and the world is now waiting with bated breath for a vaccine.

Brazil-which trails only the U.S.in terms of total reported COVID-19 cases and deaths-will produce around 30 million doses of the vaccine, with roughly half that amount available by December, UPI reported.

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