INDIA – Bharat Biotech has announced that the World Health Organization (WHO) has awarded prequalification to its rotavirus vaccine, Rotavac 5D to prevent rotavirus diarrhea.

Rotavac 5D, new variant of Rotavac, is a unique rotavirus vaccine formulation that can be administered without a buffer and its low dose volume (0.5 mL) facilitates easy vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination, the company said in a press statement.

Rotavac vaccine 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 (Pan American Health Organization). It is a validation of the global quality and safety standards required for pediatric vaccines,” Bharat Biotech said.

The company further said that prequalification of the vaccine will fast-track global access to this life saving vaccine.

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,” Suchitra Ella, Joint Managing Director- Bharat Biotech, 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.

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.

Rotavac received WHO-Prequalification in January 2018. Its efficacy for severe non-vaccine rotavirus gastroenteritis was 56.4% in the first year of life and efficacy in the second year was 49%.

To date, Rotavac holds over 10 publications showcasing its safety & effectiveness across Zambia, Vietnam & Palestine.

Rotavirus is the leading cause of severe diarrhea among children less than five years of age around the world, resulting in more than 600,000 deaths and 2 million hospitalizations worldwide, according to UNICEF data.

Last week, Samoa, a Polynesian country in the central South Pacific Ocean, reported an outbreak of rotavirus. As of 22 July 2021, 31 rotavirus cases had been confirmed by laboratory testing.

The virus spreads by the fecal-oral route; this means that the virus must be shed by an infected person and then enter a susceptible person’s mouth to cause infection.

Rotavirus vaccination is the best way to protect children against rotavirus disease. The vaccines are very effective at preventing severe rotavirus disease in infants and young children.

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