Bharat Biotech's Covaxin: Volunteer Hospitalised Due To An Adverse Reaction During Early Vaccine Trials

Everyone is eagerly waiting for the COVID-19 vaccine and many scientists across the world are working hard to develop a vaccine. Many Indian companies have come up with their vaccines. Bharat Biotech's Covaxin is termed as 60 % effective and the company is planning to launch the coronavirus vaccine candidate in Q2 of 2021. 

Bharat Biotech, in collaboration with ICMR - National Institute of Virology (NIV), is developing Covaxin and is conducting the largest Covid-vaccine clinical trials in India with 26,000 volunteers in 25 centres in its Phase III phase. In this final phase, two doses will be administered to each volunteer to determine whether the vaccine is able to prevent the development of COVID-19 or not.

Bharat Biotech recently reported to the Drug Controller General of India that during the initial stages, a participant experienced an adverse reaction. Owing to an adverse reaction, the volunteer was hospitalised. However, the company spokesman explained that the health issue that the participant developed was not related to the dosage of the vaccine administered.

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

However, the vaccine maker giant did not respond to other questions, such as whether the company has stopped the vaccine trials after the incident, etc. Dr Balram Bhargave, Director-General of the Indian Council of Medical Research, and DGCI Dr VG Somani also did not respond to the Covaxin Phase I vaccine trial queries.

Another investigator said that the trials had already started by mid-July and the participant who developed health issues was recruited in later stages. The second shot of Covaxin was administered by the end of July after the safety of the 50 participants after the first dose had been approved by the DSMB.