Bharat Biotech’s rotavirus vaccine ROTAVAC 5D receives WHO prequalification

Hyderabad-based vaccine manufacturer Bharat Biotech announced on Monday that the World Health Organisation (WHO) has awarded prequalification to its rotavirus vaccine, Rotavac 5D, to prevent rotavirus diarrhoea.

Rotavac 5D, is a unique formulation of a rotavirus vaccine 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 release. The 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 agencies such as UNICEF and PAHO (Pan American Health Organisation) and will also fast-track global access to this life-saving vaccine.

ROTAVAC and Rotavac 5D are projects conceived, innovated, and executed in India, in collaboration with Indian and global partners, said Suchitra Ella, Joint Managing Director, Bharat Biotech.

"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," 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.

What is Rotavirus?

Rotavirus is the leading cause of severe diarrhoea among children less than five years of age around the world, resulting in more than 200,000 deaths and 2 million hospitalisations worldwide. Vaccinations are an important part of global public health efforts to meet the Sustainable Developmental Goals of UNDP.

As per the manufacturers, ROTAVAC 5D is safe and effective in the prevention of rotavirus diarrhoea. It can be stored at 2-8ºC, administered in five drops orally. ROTAVAC 5D is available in single-dose, multi-dose vials, and pre-filled syringes. 

"This vaccine is safe, effective, and affordable, besides being cross-protective against a variety of rotavirus strains. Its efficacy compares favorably with the efficacy of the currently licensed rotavirus vaccines in low-resource countries. The study results showed clear evidence of protection across different rotavirus strains and continued efficacy in the second year of life," the statement added.