Bharat Biotech’s ROTAVAC 5D® receives WHO Prequalification

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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.

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.

Rotavirus Vaccine (Live Attenuated, Oral) is a monovalent liquid frozen vaccine containing live rotavirus 116E strain prepared in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of 0.5 ml contains NLT 105.0 FFU of live Rotavirus 116E. ROTAVAC® should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age and should not be administered to children older than 8 months of age.

ROTAVAC® received WHO-Prequalification in January 2018. Rotavirus 116E is isolated from asymptomatic neonates in 1986-88 at the All India Institute of Medical Sciences, New Delhi. ROTAVAC® was developed as a Social Innovation Project under a public-private partnership involving highly regarded national and international organizations. The multi-centre phase-3 efficacy and safety clinical trial on ROTAVAC® was India’s first and largest efficacy clinical trial on vaccines. It was successfully completed in September 2013 after a 2-year follow up of the infants. Results of this study were published in the Lancet.

The vaccine efficacy of ROTAVAC® for severe non-vaccine rotavirus gastroenteritis was 56.4% [95% Cl 36.6, 70.1] in the first year of life and efficacy in the second year was 49% [95% Cl 17.5, 68.4]. To date, ROTAVAC® holds >10 publications showcasing its safety & effectiveness across Zambia, Vietnam & Palestine.

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