Bharat Biotech’s ROTAVAC vaccine received prequalification in January 2018 from the World Health Organization (WHO). Vaccines are added to WHO’s prequalification list after a positive outcome of an evaluation of relevant data and after the product’s manufacturing sites are audited by WHO. Prequalified vaccines must also be manufactured and packaged to specifications required by UN organizations interested in procuring these vaccines, for example, UNICEF.
Now the manufacturer plans to contribute to providing low-cost rotavirus vaccines for children globally, especially in low- and middle-income countries where the majority of rotavirus deaths occur.
Bharat Biotech currently provides ROTAVAC vaccine through India’s Drugs Controller General as part of the country’s ongoing phased rotavirus vaccine introduction, which started in 2016 in five states and has now expanded to nine states. Already, about 35 million doses of ROTAVAC have been administered in India at $1 per dose, which is less costly per dose than other globally available vaccines.
Members of the ROTA Council have spoken about how expanding choices between vaccine product can prevent supply constraints and impact pricing. Council members are optimistic that the remarkable progress made in reducing morbidity and mortality from diarrheal disease will continue as more and more children have access to rotavirus vaccines across the world.
“Bharat Biotech’s track record of life saving vaccines is a testimony to the company’s long-standing commitment to make affordable vaccines for the developing world. ROTAVAC has been supplied to low-income countries at $1 per dose, with the feasibility for further reducing the price by 30 percent based on the procurement of around 100 million doses for these countries, said Krishna Ella, CMD, Bharat Biotech International.”
- India-made rotavirus vaccine achieves World Health Organization prequalification: ROTAVAC® will now be available for procurement by United Nations agencies and Gavi, the Vaccine Alliance, for use in low-resource countries (PATH Press Release)
- New Hope for Rotavirus Vaccine (The Daily Star, Bangladesh)
- Bharat Biotech’s diarrhoea vaccine ROTAVAC gets WHO pre-qualification (LiveMint, India)
- Bharat Biotech’s diarrhoea vaccine get WHO nod (Hindu Business Line, India)
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