May 2, 2024: In the interest of public health, Bharat Biotech reaffirmed the safety of India’s COVAXIN®️, developed using Whole-Virion Inactivated Vero Cell derived platform technology in a post. With a focus on safety above all else, COVAXIN®️ has undergone rigorous testing, including trials involving over 27,000 individuals within India.
As stated informed to public at large by the firm, inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.
Each step of its evaluation has been conducted meticulously, ensuring that safety remains paramount. Continuous monitoring is in place to guarantee safety throughout its use.
Importantly, there have been no reports of serious side effects associated with the vaccine, such as blood clots or heart issues. This commitment to safety backs Bharat Biotech’s dedication to protecting public health with safety first approach.
Key Reasons that validate the safety first approach of COVAXIN
COVAXIN®️ was developed with a single-minded focus on safety first, followed by efficacy.
- COVAXIN®️ was the only COVID-19 vaccine in the Govt 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, Govt of India.
- 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 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.
