Bharat Biotech boasts of Covaxin's 'excellent safety record' amid AstraZeneca row
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.
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.
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.
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.
