Covaxin from Bharat Biotech: volunteer hospitalized during early vaccine trials; This is what the company said

India is eagerly awaiting Covaxin, the locally made Covid-19 vaccine, which began its third phase trials in Odisha. As the Center prepares for a mega campaign, the vaccine manufacturer recently informed India’s Controller General of Drugs about a participant who developed an adverse reaction during the initial stages. The volunteer was hospitalized due to an adverse reaction. The company spokesperson, however, clarified that the health problem developed by the participant was not due to the dose of vaccine administered.

Bharat Biotech, the manufacturer of the Covaxin vaccine in an email response to IE, said that the adverse reaction with the participant occurred during their first trial with the vaccine that took place in August 2020. The participant suffered from viral pneumonitis and was hospitalized. The matter, following all guidelines, was reported to the sponsor and CDSCO-DCGI, the site’s ethics committee, the Data Security 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 at 25 centers. Two doses will be administered to each volunteer in this final phase that will evaluate if they are effectively able to prevent the development of Covid-19.

The vaccine-making giant, however, did not respond to other questions such as stopping vaccine trials after the incident occurred. Dr Balram Bhargave, Director General of the Indian Medical Research Council, and Dr VG Somani of DGCI also did not respond to questions about the Covaxin phase I vaccine trials.

Previously, Johnson and Johnson and AstraZeneca halted trial and vaccine recruitment in the late stages after their participants developed unexpected serious health problems. The trials resumed after the researchers confirmed that the health problems were not related to the doses of the vaccine.

All Covaxin investigators were not evaluated on the incident of a participant’s hospitalization. One lead investigator, however, argued that not all problems require reporting to all trial sites and that reporting to DSMB is sufficient. Another researcher said that the participant who developed health problems was recruited in later stages, since the trials had already started in mid-July. The second injection of Covaxin was given in late July after DSMB approved the safety of all 50 participants after the first dose.