Bharat Biotech issued a statement on Thursday emphasizing the safety measures taken during the development of its COVID-19 vaccine, Covaxin, amid ongoing discussions about the side effects of Covishield. This follows AstraZeneca’s recent admission in court that its vaccine could “in very rare cases” cause Thrombosis Thrombocytopenia Syndrome (TTS).
“Covaxin was developed with a strong emphasis on prioritizing safety first, followed by efficacy,” stated the company. “It was the only COVID-19 vaccine in the government’s immunization program that underwent efficacy trials in India, involving over 27,000 subjects during the licensure process,” it added.
Bharat Biotech also stated that all studies and ‘safety follow-up activities’ showed that Covaxin had no links to blood clots, thrombocytopenia, TTS, VITT, pericarditis, myocarditis, or other adverse events. This discussion has gained traction as COVID-19 vaccines return to the forefront of the political conversation due to AstraZeneca acknowledging the ‘extremely rare’ side effects.
The company made this announcement as it faces legal challenges linking its vaccine to cases of death and severe injuries. The Serum Institute of India produced Covishield, a version of the Vaxzevria vaccine, using the viral vector platform.
“TTS is a serious and life-threatening adverse event. WHO issued interim emergency guidance last year to raise awareness about TTS in the context of COVID-19 vaccination and aid healthcare providers in assessing and managing potential TTS cases,” the World Health Organization noted.
In a related development, a petition was filed in the Supreme Court on Wednesday seeking the creation of a medical expert panel supervised by a retired Supreme Court judge to examine possible side effects and risk factors of the Covishield vaccine.
