Developed by Bharat Biotech, India’s 1st COVID-19 Vaccine – COVAXIN, conducted its first human trials today.
The vaccine, co-developed in collaboration with the National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR) was administered on 3 subjects at All India Institute of Medical Sciences in Patna and Post-Graduate Institute of Medical Sciences in Rohtak, Haryana.
Haryana Health Minister Anil Vij updated that the subjects tolerated the vaccine very well and there were no adverse effects.
India’s Drug Controller General (DCGI) had earlier approved Bharat Biotech to initiate phase 1 and 2 human clinical trials.
Dr Krishna Ella Chairman and MD, Bharat Biotech
“Based on the successful results of phase 1 and phase 2, we will progress to the larger clinical trials. We are hoping all the studies meet the highest safety and efficacy standards, and if the regulators approve of them, we can expect the vaccine to be available early 2021.”
There are over seven anti-corona vaccines at various stages of development in the country with two receiving DCGI’s clearance to begin the human clinical trials of their vaccines. Gujarat-based Zydus Cadila has also received approval from authorities to start human trials for its anti-COVID-19 vaccine.
Development Summary
After receiving the virus strain from the NIV Pune, Bharat Biotech was laid out the GMP (good manufacturing practices) protocols for the manufacture of the vaccine candidate.
The first batch of GMP compliant vaccine candidates was created within 40 days.
Pre-clinical trials of the vaccine candidate were conducted on animals which were later evaluated upon WHO and Schedule Y Guidelines.
Schedule Y defines the clinical trials as the requirements and guidelines for the import and manufacture of new drugs for sale or for clinical trials. It also describes the details of the application process for conducting clinical trials; responsibilities of the sponsor, investigators and the guidelines of India’s Independent Ethics Committee.
COVAXIN was reported to be safe and immunogenic in all animals and was subsequently cleared for human clinical trials.
Next Steps
COVAXIN is currently in its Phase 1 and Phase 2 trial stage where the test of a new vaccine is conducted in a small group to evaluate a safe dosage range and identify side effects.
Upon the successful completion of Phase 1 and 2, DCGI after evaluation and verification of the test results will permit for Pase 3 trials to be conducted on larger populations in different regions of the country.
Phase 4 trials are mandated if there is a need for further testing in a wide population over a longer timeframe.
Quick facts on COVAXIN
COVAXIN is an inactivated vaccine developed from a SARS-CoV-2 (Novel coronavirus) strain which was isolated in the National Institute of Virology, Pune.
Two dosages of the vaccine candidate will be provided to the subjects at an interval of 14 Days post which they will be examined to evaluate the medication effect.
ICMR has selected 12 institutes across the country to carry out clinical trials of COVAXIN.
The vaccine candidate, Covaxin will be examined on over 1,100 people in two-phase.
The firm estimates the cycle of a clinical trial to be 15 months which should lead to commercial availability in 2021.
About Bharat Biotech
Founded in 1996, the Hyderabad-based Bharat Biotech International Limited is a public limited company which is engaged in the drug discovery, drug development, manufacture of vaccines, bio-therapeutics, pharmaceuticals and health care products.
The pharma firm has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications.
Gujarat-based Chiron Behring Vaccines which was founded in 1989, is a known subsidiary of Bharat Biotech after its acquisition in 2019.
