Bharat Biotech's coronavirusvaccine Covaxin is the first COVID-19 vaccine to get DGCI's (Drug Controller General of India) nod.
Bharat Biotech, the Hyderabad-based vaccine maker is leading the consortia consisting of the Indian Council of Medical Research (ICMR) and the Pune-based, National Institute of Virology (NIV).
Interestingly, Bharat Biotech is in collaboration with a University of Wisconsin in the development of another Vaccine too. "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 the future pandemics", Ella added.
Since the beginning of the coronavirus pandemic, scientists around the world were trying hard to develop an effective vaccine for SARS-CoV-2 and some of them claimed to be successful.
Coronavirus infection has already cost over 16,475 lives in India and the world is now waiting with bated breath for a vaccine.
CNBG has multiple experimental coronavirus vaccine candidates, and at least one of the drugs cleared Phase 2 of human trials successfully.
Despite touting the effectiveness of the vaccine, CNBG did not share the exact results from the Phase 1/2 clinical trial, which was reportedly conducted on as many as 1,120 people.
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.
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".
Bharat Biotech said it accelerated objective in completing the comprehensive pre-clinical trials, which were expedited through national regulatory protocols. Results from these studies have been promising and show extensive safety and effective immune responses. But Chinese companies have several vaccine candidates for COVID-19 in advanced testing, and a new report reveals that a different drug has received approval for military use. Under the deal, Catalent will also provide packaging and labelling, storage and distribution services to support Moderna's late-stage clinical trial for the vaccine.
The company is also involved in the development of CoroFlu, a nasal vaccine for COVID-19, as part of an global collaboration of virologists at the University of Wisconsin-Madison and vaccine firm FluGen.
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