Rotavac 5D: Bharat Biotech's Rotavirus Vaccine Receives 'Prequalification' From WHO

BHARAT BIOTECH announced on Monday that its rotavirus vaccine, Rotavac 5D, has been prequalified by the World Health Organization (WHO).

Prequalification is a method of determining a manufacturer's ability to consistently create a high-quality product in compliance with international standards and WHO/UNFPA specifications. Prequalification protects both the buyer and the end-user by ensuring the acquisition and delivery of high-quality products.

Rotavac 5D, a novel Rotavac variation, is a one-of-a-kind rotavirus vaccine formulation that can be given without a buffer. Its small dose volume (0.5 mL) makes vaccine logistics, cold chain management, and post-vaccination biomedical waste disposal simple. It's used to prevent rotavirus illness, which is common in babies and toddlers. It can be kept for up to 24 months at 2 to 8°C. When compared to the WHO Prequalified ROTAVAC, ROTAVAC 5D has similar clinical safety and immunogenicity characteristics. It comes in three different forms: single-dose vial/pre-filled syringe, and multi-dose vial. It is convenient and adaptable under Universal Immunization Programs (UIP) by countries due to the various presentations and lowest dosage form available.

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The UN organizations UNICEF and PAHO can now purchase Rotavac 5D® thanks to the WHO prequalification. The WHO prequalification of Rotavac 5D will speed up global access to this life-saving vaccine.

“Rotavac and Rotavac 5D are projects conceived, invented, and executed in India in conjunction with Indian and worldwide partners,” Suchitra Ella, joint managing director, Bharat Biotech, stated. This is the result of a 30-year effort to produce a novel rotavirus vaccine, resulting in a substantial development in Rotavirus illness prevention and reaffirming India's leadership in producing and introducing rotavirus vaccines for the rest of the globe. The announcement made on 3rd August is a significant step toward realizing Bharat Biotech's aim of addressing neglected diseases and preventing infections that continue to plague millions of people in underdeveloped countries.”

The first-generation rotavirus vaccine, Rotavac, was developed by Bharat Biotech in public-private collaboration with the Indian government's department of biotechnology and 16 additional foreign partners, making it the world's largest social innovation project for public health.

Rotavac has proved critical in preventing rotavirus infection mortality in underdeveloped nations. Bharat Biotech has distributed more than 250 million Rotavac medicines to date.

Rotavirus is the most common cause of severe diarrhea in children under the age of five years all over the world, resulting in over 200,000 fatalities and two million hospitalizations. Diarrhea and other digestive symptoms are caused by the rotavirus. It is highly contagious and the leading cause of diarrhea in infants and young children around the world. It has a spherical shape. The virus's name comes from the Latin word "rota," which means "wheel."

Rotavirus vaccine was first made accessible in four states in 2016 and then expanded to seven additional states by the end of 2018, bringing the total number of states where Rotavirus vaccine was available to 11 by the end of 2018. In 28 states and territories, the rotavirus vaccine is currently available.

Vaccinations are a critical component of worldwide public health initiatives to achieve the UNDP's sustainable development goals.