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 exceptional rotavirus vaccine formulation that can be administered devoid of a buffer. Its low dose volume (.5 mL) facilitates effortless vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination. It is utilised 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 worldwide high-quality and security requirements necessary for pediatric vaccines. WHO prequalification of ROTAVAC 5D® will quick-track worldwide access to this life saving vaccine.
Suchitra Ella, Joint Managing Director, Bharat Biotech, mentioned, “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 created the 1st generation, rotavirus vaccine, ROTAVAC® beneath a Public-Private Partnership with the Department of Biotechnology, Government of India and 16 other international partners, producing it the biggest ever social innovation project for public wellness. In the building 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 major lead to of extreme diarrhea amongst children much less than 5 years of age about the world, resulting in more than 200,000 deaths and 2 million hospitalizations worldwide. Vaccinations are an vital aspect of worldwide public wellness efforts to meet the Sustainable Developmental Goals of UNDP.
ROTAVAC 5D®, is secure and efficient in the prevention of rotavirus diarrhoea. ROTAVAC 5D® can be stored at 2-8ºC, administered in 5 drops orally. ROTAVAC 5D® is out there in single-dose, multi-dose vials, and pre-filled syringes. ROTAVAC 5D® has been evaluated in clinical trials in India and other nations. This vaccine is secure, efficient and economical, in addition to getting cross-protective against a range of rotavirus strains. Its efficacy compares favorably with the efficacy of the at the moment licensed rotavirus vaccines in low-resource nations. The study final results showed clear proof of protection across diverse rotavirus strains and continued efficacy in the second year of life.
ROTAVAC 5D® is a miniaturized economical rotavirus vaccine, delivering a potent solution with a dose volume of .5ml. It enables full delivery of the antigenic payload in 5 oral drops, avoiding spit-ups observed with bigger dose volumes. ROTAVAC 5D® is out there 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 fees due to storage, distribution, administration, and waste disposal. The vaccine stability combined with its smaller cold chain footprint enables its use in low resource settings and outreach applications.
Rotavirus Vaccine (Live Attenuated, Oral) is a monovalent liquid frozen vaccine containing live rotavirus 116E strain ready in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of .5 ml includes NLT 105. FFU of live Rotavirus 116E. ROTAVAC® really should be administered as a 3-dose regimen, 4 weeks apart, starting at 6 weeks of age and really 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 created as a Social Innovation Project beneath a public-private partnership involving hugely regarded national and international organizations. The multi-centre phase-3 efficacy and security clinical trial on ROTAVAC® was India’s 1st and biggest efficacy clinical trial on vaccines. It was effectively completed in September 2013 right after a 2-year stick to up of the infants. Results of this study had been published in the Lancet.
The vaccine efficacy of ROTAVAC® for extreme non-vaccine rotavirus gastroenteritis was 56.4% [95% Cl 36.6, 70.1] in the 1st 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 security & effectiveness across Zambia, Vietnam & Palestine.