A participant in the phase-1 clinical trials of Bharat Biotech's potential Covid-19 vaccine reported serious adverse effect and had to be admitted to a hospital but the trials were not paused and it was not disclosed in the public.
Covaxin is being developed by Hyderabad-based Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR). The vaccine is currently undergoing phase-3 trial in several medical institutes of the country, involving around 26,000 participants.
The serious adverse effect was seen in a 35-year-old participant with no comorbidities in August this year, reported Times of India.
According to Economic Times, a government official said that the matter was reported to Data and Safety Monitoring Board (DSMB) and the trials were not halted because it was found that the participant didn't fall ill due to the vaccine dose.
The official said that adverse effect did not cause any life-threatening reaction in the participant so the trials were not halted.
The participant, in western parts of the country, was hospitalised with viral pneumonitis, a couple of days after being administered the vaccine and was allowed to leave the hospital after a week.
Medical experts say Bharat Biotech violated international practices on vaccine trial
Public health experts, however, expressed concerns over Bharat Biotech's decision not to pause the trials despite the adverse event and went against the international practices of halting the trials in such events.
Such adverse events are normal in such large-scale clinical trials of drugs and vaccines. Trials of coronavirus vaccine being developed by AstraZeneca and Oxford University, by Johnson & Johnson were halted due to serious adverse events. The trials were resumed after authorities concluded that it was safe to do so.
Bharat Biotech Chairman and Managing Director Krishna Ella, while addressing a webinar on Friday, said that the company followed due process and international guidelines. "There was a reason not to reported everything to the press," he was quoted as saying by Economic Times.
Currently, clinical trials were underway for several coronavirus vaccine candidates in the country are in different phases of the human clinical trials, with Covaxin being the only vaccine in the third phase of trials.