The Hyderabad-based company issued a statement amid questions being raised in some quarters over the safety of Covid vaccines after global drugmaker AstraZeneca admitted that its Covid vaccine Covishield, developed by researchers at the University of Oxford, may cause a blood clotting disorder. Can cause rare side effects and low platelet count after vaccination.
About 175 crore doses of Covishield, developed by AstraZeneca and manufactured by Pune-based Serum Institute, were reportedly administered in India.
Bharat Biotech noted that Covaxin is the only COVID-19 vaccine in the Government of India's COVID-19 vaccination program to have been efficacy tested in India.
The vaccine manufacturer said, “Covaxin was evaluated in more than 27,000 subjects as part of the licensing process. It was licensed under restricted use in the clinical trial mode, where several hundred thousand subjects “Detailed safety reporting was conducted.”
The safety of Covaxin was also evaluated by the Health Ministry.
“Continuous safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin. All the above studies and safety follow-up activities have demonstrated an excellent safety profile for Covaxin without the incidence of vaccine-related blood clots, thrombocytopenia, TTS, VITT. Records have demonstrated pericarditis, myocarditis, etc.,” it said.
“As experienced innovators and product developers, the Bharat Biotech team was well aware that, although the efficacy of COVID-19 vaccines may be short-term, its impact on patient safety can be life-long. Safety is therefore the primary focus for us There is focus." Vaccines,” it added.
About 175 crore doses of Covishield, developed by AstraZeneca and manufactured by Pune-based Serum Institute, were reportedly administered in India.
Bharat Biotech noted that Covaxin is the only COVID-19 vaccine in the Government of India's COVID-19 vaccination program to have been efficacy tested in India.
The vaccine manufacturer said, “Covaxin was evaluated in more than 27,000 subjects as part of the licensing process. It was licensed under restricted use in the clinical trial mode, where several hundred thousand subjects “Detailed safety reporting was conducted.”
The safety of Covaxin was also evaluated by the Health Ministry.
“Continuous safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin. All the above studies and safety follow-up activities have demonstrated an excellent safety profile for Covaxin without the incidence of vaccine-related blood clots, thrombocytopenia, TTS, VITT. Records have demonstrated pericarditis, myocarditis, etc.,” it said.
“As experienced innovators and product developers, the Bharat Biotech team was well aware that, although the efficacy of COVID-19 vaccines may be short-term, its impact on patient safety can be life-long. Safety is therefore the primary focus for us There is focus." Vaccines,” it added.
