Covaxin demonstrated 'excellent safety track record,' says Bharat Biotech

Bharat Biotech said that the vaccine demonstrated an 'excellent safety track record' in several studies. They said, “For a study to be effective, informative, and to avoid investigator bias, a few data points are required, including the AESI (Adverse Events of Special Interest) safety profile of the subjects prior to their participation in the study."

“All study participants should be followed during the study, instead of only a subset. 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.

Earlier, a Banaras Hindu University (BHU) study conducted from January 2022 to August 2023 stated that nearly one-third of 926 individuals who received the anti-COVID-19 vaccine by Bharat Biotech, Covaxin, reported AESI. 

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

The study also claimed that nearly 50 percent 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 court that its COVID vaccine can cause rare side-effects of blood clotting and a lowering of platelet count, published in the journal Springer Nature.