Amid concerns raised over potential side effects of AstraZeneca's Covid-19 vaccine, Bharat Biotech, the developer of Covaxin, emphasized the safety of its own vaccine. In a statement shared on its official handle, Bharat Biotech underscored its commitment to prioritizing safety during the development of Covaxin, followed by efficacy considerations.
Highlighting Covaxin's safety record, Bharat Biotech noted that it conducted efficacy trials within India, involving over 27,000 participants, as part of the vaccine's licensure process. It further mentioned that Covaxin underwent detailed safety reporting for hundreds of thousands of subjects during its licensure under restricted use in clinical trial mode. Additionally, the Ministry of Health, Government of India, evaluated Covaxin's safety, and ongoing pharmacovigilance monitoring continued throughout the vaccine's lifecycle.
Bharat Biotech asserted that Covaxin demonstrated an "excellent safety record," with no reports of vaccine-associated incidents such as blood clots, thrombocytopenia, pericarditis, or myocarditis. The company emphasized its unwavering focus on safety, recognizing that while vaccine efficacy may vary, ensuring patient safety remains paramount.
The statement comes in the wake of AstraZeneca's acknowledgment, through court documents, of rare blood clot-related side effects associated with its Covid-19 vaccine. Sold globally under various brand names, including Covishield in India, the AstraZeneca vaccine faced legal scrutiny following allegations of serious injuries and deaths. Plaintiffs, including Jamie Scott, who suffered a permanent brain injury after receiving the AstraZeneca vaccine, brought forth a class-action lawsuit highlighting rare side effects like Thrombosis with Thrombocytopenia Syndrome (TTS), characterized by blood clots and low platelet counts.