Bharat Biotech on Thursday asserted that its Covid-19 vaccine Covaxin is safe and devoid of any side-effects amid AstraZeneca's admission that Covishield could cause complications in rare cases.
In a statement, the company stated that Covaxin was developed with a single-minded focus on safety first, followed by efficacy.
The vaccine was evaluated in more than 27,000 subjects as part of its licensure process, Bharat Biotech stated.
It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects, it noted.
The vaccine was also evaluated by the Union Ministry of Health, it said.
Besides, safety monitoring (pharmacovigilance) was continued throughout the product life cycle of Covaxin, it stated.
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, Bharat Biotech 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.
Covaxin was the only Covid-19 vaccine in the Govt of India's Covid-19 immunisation programme to have conducted efficacy trials in India, the vaccine major stated.
Bharat Biotech's statement comes days after AstraZeneca admitted in court that its vaccine could in very rare cases cause thrombosis with thrombocytopenia syndrome.
The AstraZeneca vaccine, which was manufactured by the Serum Institute of India, was sold in the country under the name Covishield.
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