Amid a debate over AstraZeneca’s admission that its Covid-19 vaccine, sold as Covishield in India, could cause “rare” side effects, Bharat Biotech, the vaccine maker that developed Covaxin, boasted about its safety record.
In a statement released on its X handle, Bharat Biotech said that Covaxin was developed with a single-minded focus on safety first, followed by efficacy.
The vaccine maker also said that Covaxin was the only Covid-19 vaccine in the government’s Covid-19 immunisation programme to have conducted efficacy trials in India.
“Covaxin was evaluated in more than 27,000 subjects as part of its licensure process. It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects,” Bharat Biotech said.
“Safety of Covaxin was also evaluated by the Ministry of Health, Government of India. Ongoing safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin,” it stated.
The company said that studies and follow-up activities demonstrated its “excellent safety record” for Covaxin and that there were no reports of vaccine-associated incidents, including blood clots, Thrombocytopenia, pericarditis and myocarditis.
“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,” it further said.
Recently, AstraZeneca admitted for the first time in court documents that its Covid-19 vaccine, in “very rare cases”, could cause a blood clot-related side effect. The AstraZeneca Covid-19 vaccine was sold globally under the brand names Covishield and Vaxzevria among others.
The AstraZeneca vaccine, manufactured by the Serum Institute of India (SII), was marketed in India as Covishield.
The pharmaceutical company was facing a class-action lawsuit alleging serious injuries and deaths resulting from its vaccine, developed in collaboration with the University of Oxford.
The lawsuit was initiated by Jamie Scott, who suffered a permanent brain injury after receiving the AstraZeneca vaccine in April 2021.
His case, among others, highlights the severe impact of a rare side effect known as Thrombosis with Thrombocytopenia Syndrome (TTS), characterised by blood clots and low platelet counts.
