COVAXIN was developed with a single-minded focus on safety first, followed by efficacy, says Bharat Biotech
Hyderabad: Bharat Biotech here on Thursday announced that COVAXIN was developed with a single-minded focus on safety first, followed by efficacy.
In a tweet posted in view of public interest, Bharat Biotech said COVAXIN was the only COVID-19 vaccine in the Government of India's COVID-19 immunisation program 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.
Safety of COVAXIN was also evaluated by the Ministry of Health and the 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.
As seasoned innovators and product developers, the Bharat Biotech team was well-aware that, while efficacy of covid vaccines may be short-lived, the impact on patient safety could last a lifetime. Hence safety is always the primary focus for all our vaccines, the company said.