The COVID-19 vaccine developed in India, Covaxin, has been approved through the Indian General Drug Controller (DGCI) for the third of the clinical trials. The vaccine, which is being developed through Hyderabad-based Bharat Biotech, in collaboration with the Indian Medical Research Council (ICMR), had requested approval of phase 3 trials on 2 October.
In their third-stage permit application, the developers stated that the trials would cover approximately 28,500 subjects over the age of 18 and would also be conducted at 19 sites, adding Delhi, Mumbai, Patna and Lucknow.
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In early September, Bharat Biotech reported that covaxine had been shown to be effective in inducing Immunity against COVID-19 in animals. macaques, which were slightly divided into 4 groups. The effects showed protective efficacy, expanding SARS-CoV-2-specific IgG and neutralizing antibodies, cutting virus replication into the monkey’s nasal cavity, throat and lung tissue.
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“In short, the candidate vaccine was found to generate physically powerful immune responses. Therefore, the prevention of infections and diseases in primates during maximum exposure to the live SARS-CoV-2 virus,” he concludes.
Bharat Biotech was approved by DCGA in July for Phase I and II clinical trials to expand an indigenous vaccine opposed to COVID-19. Covaxine is the first vaccine developed as opposed to COVID-19 through India. Harat Biotech collaborated with Indian Medical Research. (ICMR) and the National Institute of Virology (NIV) to expand the vaccine. In addition to Covaxin, India has two other vaccine applicants underway: ZyCoV-D from Zydus Cadila, founded in Ahmedabad, and some others are being evolved through the Serum Institute of India in collaboration with the University of Oxford vaccine and British pharmaceutical giant AstraZeneca.
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