COVAXIN, India’s first vaccine against novel coronavirus, developed by Bharat Biotech gets the approval of the Drug Controller General of India (DCGI) for Phase I and II human trials.
- Bharat Biotech gets approval on human trials after submitting results generated from preclinical studies, demonstrating safety and immune response.
- Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) developed this vaccine.
- According to Bharat Biotech, human clinical trials of the experimental COVID-19 are scheduled to start across the country in July 2020.
- The indigenous, inactivated vaccine has been developed and manufactured at Bharat Biotech’s Bio-Safety Level 3 (BSL-3 ) High Containment facility located in Genome Valley, Hyderabad.
- According to the company, COVAXIN has been expedited through national regulatory protocols, and subjected to "comprehensive pre-clinical studies", which reports that the results are "promising" and "show extensive safety and effective immune responses".
- In the past, Bharat Biotech has manufactured the H1N1 vaccine during the swine flu outbreak.
- The most significant of their developments are the rotavirus vaccine Rotavac, a next-gen vaccine against viral gastroenteritis that got pre-approval from the WHO.
Clinical trials in humans are classified into three phases:
- Phase I: Clinical studies carry out initial testing of a vaccine in small numbers (e.g. 20) of healthy adults, to test the properties of a vaccine, its tolerability, and, if appropriate, clinical laboratory and pharmacological parameters. Phase I studies are primarily concerned with safety.
- Phase II: It involves larger numbers of subjects and is intended to provide preliminary information about a vaccine’s ability to produce its desired effect (usually immunogenicity) in the target population and its general safety.
- Phase III: These trials are required to fully assess the protective efficacy and safety of a vaccine. The trial is the pivotal study on which the decision on whether to grant the license is based and sufficient data have to be obtained to demonstrate that a new product is safe and effective for the purpose intended.
Source: The Hindu