Bharat Biotech’s ROTAVAC 5D® Receives WHO Prequalification

Hyderabad : Bharat Biotech today announced that the World Health Organization (WHO) has awarded prequalification to its rotavirus vaccine, ROTAVAC 5D®. The new variant of ROTAVAC®, ROTAVAC 5D®, is a unique rotavirus vaccine formulation that can be administered without a buffer. Its low dose volume (0.5 mL) facilitates easy vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination. It is used for the prevention of rotavirus infection, which is prevalent in infants and young children.

WHO Prequalification enables the procurement of ROTAVAC 5D® by UN agencies namely UNICEF and PAHO. It is a validation of the global quality and safety standards required for pediatric vaccines. WHO prequalification of ROTAVAC 5D® will fast-track global access to this life saving vaccine.


Mrs. Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “ROTAVAC® and ROTAVAC 5D® are projects conceived, innovated, and executed in India; in collaboration with Indian and Global partners. This is the culmination of a 30 year effort to develop a novel rotavirus vaccine, resulting in a major advancement in Rotavirus disease prevention and reasserts India’s leadership in developing and introducing rotavirus vaccines for the world. Today’s announcement is an important step to further strengthen and fulfill Bharat Biotech’s vision to address neglected diseases and prevent infections that continue to affect millions in the developing world.”

Bharat Biotech developed the first generation, rotavirus vaccine, ROTAVAC® under a Public-Private Partnership with the Department of Biotechnology, Government of India and 16 other international partners, making it the largest ever social innovation project for public health. In the developing world, ROTAVAC® has been instrumental in addressing deaths due to rotavirus infection. Bharat Biotech has so far supplied more than 250 million doses of ROTAVAC®.

Rotavirus is the leading cause of severe diarrhea among children less than five years of age around the world, resulting in more than 200,000 deaths and 2 million hospitalizations worldwide. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP.


ROTAVAC 5D®, is safe and effective in the prevention of rotavirus diarrhoea. ROTAVAC 5D® can be stored at 2-8ºC, administered in 5 drops orally. ROTAVAC 5D® is available in single-dose, multi-dose vials, and pre-filled syringes. ROTAVAC 5D® has been evaluated in clinical trials in India and other countries. This vaccine is safe, effective and affordable, besides being cross-protective against a variety of rotavirus strains. Its efficacy compares favorably with the efficacy of the currently licensed rotavirus vaccines in low-resource countries. The study results showed clear evidence of protection across different rotavirus strains and continued efficacy in the second year of life.

ROTAVAC 5D® is a miniaturized affordable rotavirus vaccine, delivering a potent product with a dose volume of 0.5ml. It enables complete delivery of the antigenic payload in 5 oral drops, avoiding spit-ups observed with larger dose volumes. ROTAVAC 5D® is available in multi-dose vials with cold chain footprints of ~4 cm3 / dose, the smallest cold chain footprint of any rotavirus vaccine, and saving cold chain costs due to storage, distribution, administration, and waste disposal. The vaccine stability combined with its small cold chain footprint enables its use in low resource settings and outreach programs.


Comments are closed.