Bharat Biotech says its Covaxin demonstrated ‘excellent safety records’
AstraZeneca admitted in a UK court that its Covid vaccine can cause a rare but serious side effect, Bharat Biotech said its Covaxin has demonstrated excellent safety records without vaccine-associated incidents such as blood clots, thrombocytopenia, TTS, VITT, pericarditis and myocarditis.
Covaxin was the second most used Covid vaccine in India, after AstraZeneca’s vaccine that was produced locally by Serum Institute of India under the Covishield brand.
Covaxin was developed with a single-minded focus on «safety first», followed by efficacy, Bharat Biotech said, while admitting that the efficacy of Covid-19 vaccines may be «short-lived».
Studies and safety follow-up activities «have demonstrated an excellent safety record» for Covaxin, the company said. Covaxin was the only Covid-19 vaccine in the government's immunisation programme to have conducted efficacy trials in India, it claimed.
«Covaxin was evaluated in more than 27,000 subjects as part of its licensure process,» the company said in a statement.
The vaccine was licensed under restricted use in clinical trial mode.
«Safety of Covaxin was also evaluated by the health ministry. Ongoing safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin,» it said.
According to Bharat Biotech, as product developers, its 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 said.
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