Clinical evaluation is a critical step in the process of vaccine development. Being the first stage at which the vaccine is first tested on humans, this phase is extremely crucial. All our clinical trials are built on the rigorous ethical principles of informed consent from volunteers, strongly emphasizing safety and efficacy of vaccines.
At Bharat Biotech, we conduct extensive clinical trials to evaluate the safety and efficacy of all of our products. All three phases of clinical trials and post-marketing surveillance is carried out at designated sites. The sites and trials are strictly monitored by experienced professionals from our Clinical Research Department. Trials are initiated only upon approval from the National Regulatory Authority after conforming to all ethical guidelines.
A few of our well-known clinical trials include:
- India’s first efficacy clinical trial for our rotavirus vaccine ’ROTAVAC’. A trial of massive scale, it included around 6800 participants in three geographical sites, namely Delhi, Pune and Vellore. Results of this trial were published in journals such as the Lancet and Vaccine.
- Phase III clinical trial for TYPBAR-TCV (Typhoid Conjugate Vaccine) was carried out on around 700 participants and results were published in the Clinical Infectious Diseases journal.
- Typhoid Human Challenge study was carried out at Oxford University with TYPBAR-TCV and results of this were published in the Lancet. The trial was also covered by The New York Times.
- COVAXIN® − India's 1st Indigenous COVID-19 vaccine, demonstrated 77.8% vaccine efficacy against symptomatic COVID-19 disease. COVAXIN® has proven to neutralize the variants - B.1.1.7 (Alpha), P.1- B.1.1.28 (Gamma) & P.2 - B.1.1.28 (Zeta), B.1.617 (Kappa), B.1.351 & B.1.617.2 (Beta & Delta).
All clinical trials are registered in Clinical Registry of India: