Bharat Biotech’s Covaxin caused hospitalisation during early trials due to ‘adverse reaction’

India is waiting anxiously for Covaxin, the indigenously made Covid-19 vaccine, which started with its third phase trials in Odisha. As the Centre prepares for a mega drive, the vaccine maker recently reported to the Drug Controller General of India about a participant developing an adverse reaction during initial stages. The volunteer was hospitalised due to an adverse reaction. The company spokesperson, however, clarified that the health issue developed by the participant was not due to the vaccine dose administered.

Bharat Biotech, the Covaxin vaccine maker in an email response to IE, said the adverse reaction with the participant happened during its first trial with the vaccine that was conducted in August 2020. The participant suffered from viral pneumonitis and was hospitalised. The matter, following all guidelines, was reported to the sponsor and CDSCO-DCGI, the site ethics committee, Data Safety Monitoring Board (DSMB) within 24 hours of its occurrence.

Bharat Biotech is developing Covaxin in collaboration with ICMR – National Institute of Virology (NIV). In its Phase III, it is conducting its largest clinical trial of a Covid-vaccine in India with 26,000 volunteers in 25 centres. Two doses will be administered to each volunteer in this final phase that will evaluate if it indeed is able to prevent the development of Covid-19.

The vaccine maker giant, however, did not respond to other queries like if they halted the vaccine trials after the occurrence of the incident. Indian Council of Medical Research Director-General Dr Balram Bhargave and DGCI Dr VG Somani also did not respond to the queries about Covaxin Phase I vaccine trials.

Earlier Johnson and Johnson and AstraZeneca halted vaccine trial and recruitment in last stages after their participants developed unanticipated serious health issues. The trials resumed after investigators confirmed that the health issues were not related to the vaccine doses.

All Covaxin investigators were not appraised about the incident of a participant being hospitalized. A Principal investigator, however, argued that that not all issues require to be informed to every trial site and reporting to DSMB is enough. Another investigator said that the participant who developed health issues was recruited in later stages as the trials had already begun by mid-July. The second shot of Covaxin was administered to by the end of July after DSMB approved the safety of the 50 participants after the first dose.