New Delhi: Bharat Biotech has admitted that it had an adverse incident of its coronavirus vaccine Covaxin during the phase 1 trial back in August when a patient was hospitalised with a dose of the vaccine candidate. However, the pharma later clarified that it reported the event within 24 hours. Also Read - Covaxin, Covishield, ZyCOV-D: Where COVID Vaccines Stand Against Each other in Developmental Stage | Explained
“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,” Bharat Biotech released a statement. Also Read - PM Modi Concludes 3-City Vaccine Tour: Highlights From His Visit to Key COVID Facilities
Notably, AstraZeneca and Johnson & Johnson, who are also developing COVID-19 vaccines, had temporarily halted their phase 3 clinical trial when they witnessed an adverse event in a patient. Also Read - Serum Institute to Provide 3 Crore Vaccine Doses to Dhaka as India Signs Deal With Bangladesh
Unlike these, Bharat Biotech’s incident came to light only on Saturday after being reported by several media houses.
As per a report by The Times of India, the event happened to 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 and was discharged from the hospital after a week.
Bharat Biotech is conducting three-stage clinical trials of the indigenously developed Covaxin, in collaboration with apex bio-research agency the Indian Council of Medical Research (ICMR).
Human trials of Covaxin had begun at Rohtak’s Post-Graduate Institute of Medical Sciences in July. The company said it got an approval for the next two phases of clinical trials only after a detailed investigation of the incident was completed.
Bharat Biotech had on Monday said the Phase 3 trial of Covaxin will involve 26,000 volunteers across 25 centres in India and it is being conducted in partnership with the ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India.
Earlier on Saturday, Haryana Health Minister Anil Vij was administered a trial dose of the potential coronavirus vaccine, becoming the first volunteer for the phase three trial of Covaxin across the country.
Vij is stated to be the first cabinet minister of any state government who has volunteered to take the trial dose of a potential vaccine against COVID-19.