Bharat Biotech stresses on Covaxin’s safety record after AstraZeneca admits to Covishield causing rare clotting side effects

HYDERABAD: After AstraZeneca’s admitted in a UK court that its Covid-19 vaccine caused a rare side-effect — Thrombosis with Thrombocytopenia Syndrome (TTS), Hyderabad-based vaccine maker Bharat Biotech on Thursday stressed on the safety of its indigenous vaccine Covaxin to allay public concerns over Covid vaccines.
AstraZeneca’s vaccine Vaxzevria, which it developed in collaboration with Oxford University, was manufactured under the Covishield brandname in India by Pune-based Serum Institute of India (SII). Bharat Biotech developed the inactivated whole virion vaccine Covaxin. Both of them were the most widely administered vaccines under India’s Covid-19 vaccine immunisation drive.
Bharat Biotech said Covaxin, which was developed with a single-minded focus on safety first, had demonstrated an excellent safety record without any vaccine-associated incidents of blood clots, Thrombocytopenia, TTS, VITT, pericarditis or myocarditis, among others.”All the studies and safety follow-up activities have demonstrated an excellent safety record for Covaxin, without any vaccine-associated incidents of blood clots, Thrombocytopenia, TTS, VITT, pericarditis, myocarditis, etc,” Bharat Biotech said in a public interest statement.
Pointing out that Covaxin was the only Covid-19 vaccine in the Indian govt’s immunisation programme to have conducted efficacy trials in India, the company said Covaxin was evaluated in over 27,000 subjects as part of its licensure process and was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects.
Bharat Biotech also pointed out that ongoing safety monitoring was continued throughout the product life cycle of Covaxin with studies and safety follow-up activities demonstrating an excellent safety record.
“As seasoned innovators and product developers, the Bharat Biotech team was well aware that, while the efficacy of Covid-19 vaccines may be short-lived, the impact on patient safety could last a lifetime. Hence safety is the primary focus for all our vaccines,” Bharat Biotech said.
“The vaccine is developed using whole-virion inactivated vero cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead viruses, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection,” a company spokesperson said.