Bharat Biotech says Covaxin demonstrated ‘excellent safety track record’ in studies

Responding to a Banaras Hindu University (BHU) study that stated that nearly one-third of 926 individuals who received the anti-COVID-19 vaccine by Bharat Biotech, Covaxin, reported 'adverse events of special interest’ or AESI, Bharat Biotech said that the vaccine demonstrated “excellent safety track record” in several studies. 

Bharat Biotech said that for a study to be effective, informative and to avoid investigator bias, a few data points are required, including the AESI safety profile of the subjects prior to the participation in the study. 

It said that a comparison of safety profile of non-vaccinated subjects during the course of the study, comparison of safety profile of subjects who received other vaccines during the course of the study should be included. “All study participants should be followed during the course of the study, instead of only a subset,” stated the vaccine-maker. 

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

According to the BHU study, serious AESI such as stroke and an autoimmune disorder known as Guillain-Barre syndrome were also reported in 1 per cent of the individuals. The BHU study looked at long-term safety of the BBV152 (Covaxin) vaccine in adolescents and adults.

BHU researchers conducted the study from January 2022 to August 2023. The study revealed that nearly 50 per cent of the sample size complained of infections during the follow-up period, predominated by viral upper respiratory tract infections.

This study comes after UK pharmaceutical giant AstraZeneca admitted in a court that its Covid vaccine can cause rare side-effects of blood clotting and lowering of platelet count in a UK court.