Indias first COVID-19 vaccine COVAXIN gets nod for human trials

Cheryl Sanders
July 1, 2020

Krishna Ella, Chairperson and Managing Director of Bharat Biotech had made the announcement stating that the collaboration with ICMR and NIV has been instrumental in developing Covaxin.

The company is in discussion with the National Institutes of Allergy and Infectious Diseases with an objective to start the Phase 3 clinical trial ahead of its original schedule, pending outcome of Phase 1/2a studies and approval of regulators, the Belgium-based scientist added. The permission for human clinical trials was granted by DCGI after Bharat Biotech submitted results generated from preclinical studies, demonstrating safety and immune response. 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.

CanSino said yesterday that China's Central Military Commission approved the use of the vaccine on June 25, for one year.

The agency issued guidance to vaccine developers in conjunction with testimony by FDA Commissioner Stephen Hahn and other health officials before the Senate Health, Education, Labor and Pensions Committee on how schools and businesses can safely reopen amid the pandemic.

CanSino had previously announced in May that the Canadian government was allowing human trials of the Ad5-nCoV vaccine. "Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform".

Most experts think a coronavirus vaccine is likely to become available by mid-2021, about 12-18 months after the new virus, known officially as Sars-CoV-2, first emerged.

While there are multiple vaccine trials ongoing in India, including those of candidates by Zydus Cadila, Serum Institute of India and Panacea Biotec, all of them are in pre-clinical stage as of now. Over a dozen vaccine candidates are now in development around the world, including several from China. While 129 are in the pre-clinical evaluation phase.

Another 131 candidate vaccines listed by the World Health Organization are in the pre-clinical phase.

The two trials are created to test whether the vaccine is safe, rather than whether it is effective.

The company's efforts, part of the global race to develop a vaccine against COVID-19, comes as the pandemic continues its spread with more than 10 million cases and over 5,05,000 fatalities across the world. He said the FDA is committed to expedite a covid-19 vaccine, but "will not cut corners in our decision-making".

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