Covaxin, developed by Bharat Biotech, is currently undergoing phase-3 trials. But an "adverse event" took place during the phase 1 trial of its coronavirus vaccine candidate in August, when a patient was hospitalised after receiving a dose of the COVID-19 vaccine. The matter, however, was not made public.
In a statement on Saturday, the company said that the "adverse event" during phase I clinical trials during August 2020 was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation. "The adverse event was investigated thoroughly and determined as not vaccine related," the company was quoted as saying by the LiveMint.
Earlier, AstraZeneca and Johnson & Johnson had temporarily halted their phase 3 clinical trial immediately after an adverse event was observed in a patient each after being administered vaccines.
Covaxin is being developed by Bharat Biotech, in collaboration with the ICMR - National Institute of Virology (NIV). On October 2, the city-based vaccine-maker had sought the Drug Controller General of India's (DCGI) permission to conduct phase-3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vacine.
The Phase-III trials of Covaxin involve 26,000 volunteers across 25 centres in India and it is being conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India. This is Indias first phase-3 efficacy study for a COVID-19 vaccine, and the largest phase-III efficacy trial ever conducted in the country.
Participating volunteers, who undergo vaccination in the phase-II trials, would be monitored over the next year to detect occurrence of COVID-19. The trial volunteers would receive two intramuscular injections approximately 28 days apart.