WHO Prequalification Awarded to Bharat Biotech's Rotavac 5D Vaccine for Infants. Know What it Means

Bharat Biotech on Monday announced that the World Health Organisation (WHO) has awarded prequalification to Rotavac 5D, a vaccine to be used for the prevention of rotavirus infection, which is prevalent in infants and young children. The Rotavac 5D is an oral vaccine and is considered as the world’s lowest dose-volume rotavirus vaccine.

WHAT IS ROTAVIRUS?

According to the Centres for Disease Control and Prevention (CDC), rotavirus spreads easily among infants and young children. It can cause severe watery diarrhea, vomiting, fever, and abdominal pain. Children who get rotavirus disease can become dehydrated and in extreme condition may need to be hospitalised.

Rotavirus vaccine is the best way to protect the child against rotavirus disease, the CDC says.

WHAT PREQUALIFICATION MEANS?

Prequalification is a systematic process to determine the capacity of a manufacturer to produce a product of consistent quality in accordance with international standards and WHO/UNFPA specifications. The purpose of prequalification is to protect the buyer and the end user by ensuring good quality products are procured and distributed, as per the WHO.

WHO Prequalification enables the procurement of Rotavac 5D by agencies such as UNICEF and PAHO (Pan American Health Organisation) and will fast-track global access to this life saving vaccine.

ABOUT BHARAT BIOTECH’S ROTAVAC 5D

In the official statement, the Bharat Biotech said that the new variant of Rotavac, Rotavac 5D, is a unique rotavirus vaccine formulation that can be administered without a buffer. It is also low dose volume (0.5 mL) which facilitates easy vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination.

Quoting an official of the Hyderabad-based company, The Hindu Business Line had in 2019 reported that all other variants of rotavirus vaccine manufactured by competitors are at 2-2.5 ml per dose.

Speaking on the pricing of the rotavirus vaccine, the official had said that while Rotavac is being supplied to the government at less than Rs 70 per dose, the price for Rotavac 5D is likely to be slightly higher at close to Rs 105 per dose.

In the private set-ups both Rotavac and Rotavac 5D are being pegged at over ten times costing between Rs 900-Rs 1100 per dose.

It is usually given as a three-dose oral regimen, four weeks apart, beginning at six weeks of age.

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. “Todays 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,” she said.

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.

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