COVAXINTM, India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.
Covaxin is an inactivated vaccine. That is, it introduces a part of the novel coronavirus – instead of the whole – into the human body to provoke the sort of immune response that the body will remember. When in future an actual novel coronavirus infection is underway, the body will know what to do to flush the virus out of the body and end the infection.
The vaccine received DCGI approval for Phase I & II Human Clinical Trials and the trials commenced across India from July, 2020.
After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centres across India.
The company said that its COVID-19 vaccine is expected to be 60% efficacious, and certainly more than 50%. The results from the vaccine candidate’s phase 1 and 2 trials, and divulged the phase 3 trial’s design are yet to be shared by company.
The company had issued a statement on November 21, that a participant of Covaxin’s phase I trial had developed an adverse reaction to receiving the vaccine, in August. The statement added that the company had reported the incident to the Central Drugs Standard Control Organisation “within 24 hours”.
The adverse event occurred in a 35-year old participant with no co-morbidities, who was part of Phase 1 trials at a site in western India.
The participant was hospitalised with viral pneumonitis, a couple of days after being administered the vaccine. He was discharged after a week’s stay in the hospital.
According to Bharat Biotech, the adverse incident was assessed thoroughly and it was found that the adverse event was not related to the vaccine.
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