bharat-biotech-defends-covaxin-s-safety-amid-bhu-study-findings

Bharat Biotech has reiterated the robust safety profile of its anti-COVID-19 vaccine, Covaxin, following a study by Banaras Hindu University (BHU) indicating that nearly one-third of 926 individuals who received the vaccine reported 'adverse events of special interest' (AESI).

 

The BHU study, conducted between January 2022 and August 2023, found that serious AESIs, including stroke and Guillain-Barre syndrome, were reported in 1 percent of the individuals.

 

The study highlighted that nearly 50 percent of participants experienced infections during the follow-up period, predominantly viral upper respiratory tract infections.

 

In response to these findings, Bharat Biotech emphasized the necessity of comprehensive data collection for effective and unbiased studies.

 

"For a study to be informative and to avoid investigator bias, it is essential to include several data points," the company stated.

 

This includes the AESI safety profile of subjects prior to their participation, comparisons of safety profiles between vaccinated and non-vaccinated individuals, and comparisons with those who received other vaccines.

 

Bharat Biotech also stressed the importance of following all study participants throughout the study period, rather than just a subset.

 

“Several studies have been executed on the safety of COVAXIN, and published in peer-reviewed journals, demonstrating an excellent safety track record,” Bharat Biotech asserted in its statement. 

 

This development comes on the heels of a recent admission by UK pharmaceutical giant AstraZeneca in a court case that its COVID-19 vaccine can cause rare side effects, such as blood clotting and a reduction in platelet count.

 

The BHU research focused on the long-term safety of the BBV152 (Covaxin) vaccine in both adolescents and adults.