Covaxin has excellent safety record, says Bharat Biotech
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Hyderabad, May 2: Bharat Biotech on Thursday said that its Covid-19 vaccine Covaxin has an excellent safety record without any vaccine-associated incidents of blood clots, thrombocytopenia, TTS, VITT, pericarditis, myocarditis, etc, as it was developed with a single-minded focus on safety first, followed by efficacy.
The Hyderabad-based company issued a statement amid questions being raised in some quarters over the safety of Covid vaccines after global pharmaceutical manufacturer AstraZeneca admitted that its Covid vaccine Covishield, developed by researchers from Oxford University, can cause a rare side effect of blood clotting and low platelet count after immunisation.
As many as 175 crore doses of Covishield, developed by AstraZeneca and manufactured by Pune-based Serum Institute, were reportedly administered in India.
Bharat Biotech mentioned that Covaxin was the only Covid-19 vaccine in the Indian 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," the vaccine manufacturer said.
The safety of Covaxin was also evaluated by the Ministry of Health.
"Ongoing 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 record for Covaxin without any vaccine-associated incidents of blood clots, Thrombocytopenia, TTS, VITT, pericarditis, myocarditis, etc.," it said.
"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 added.
The Hyderabad-based company issued a statement amid questions being raised in some quarters over the safety of Covid vaccines after global pharmaceutical manufacturer AstraZeneca admitted that its Covid vaccine Covishield, developed by researchers from Oxford University, can cause a rare side effect of blood clotting and low platelet count after immunisation.
As many as 175 crore doses of Covishield, developed by AstraZeneca and manufactured by Pune-based Serum Institute, were reportedly administered in India.
Bharat Biotech mentioned that Covaxin was the only Covid-19 vaccine in the Indian 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," the vaccine manufacturer said.
The safety of Covaxin was also evaluated by the Ministry of Health.
"Ongoing 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 record for Covaxin without any vaccine-associated incidents of blood clots, Thrombocytopenia, TTS, VITT, pericarditis, myocarditis, etc.," it said.
"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 added.
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