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rotavirus vaccine 116E

Development stage
Phase 3
Lead developer
Bharat Biotech
Modality
Live Attenuated Vaccines → Live Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

Rotavirus vaccine 116E is a live attenuated, oral monovalent vaccine developed from the human-bovine reassortant rotavirus strain known as "116E." The strain was originally isolated in India and contains a single gene segment encoding VP4 derived from bovine origin, with the rest of the genome of human origin. The primary indication is for active immunization of infants starting at six weeks of age to prevent gastroenteritis caused by rotavirus infection. The mechanism of action involves immunostimulation—exposure to live attenuated virus induces an immune response that protects against subsequent natural infection. Clinical trials have demonstrated efficacy comparable to other leading rotavirus vaccines, particularly in developing countries[1][3][5][6][7]. Bharat Biotech led development and manufacturing, with support from Indian government agencies, PATH (supported by the Bill & Melinda Gates Foundation), and academic partners[6][8].

Brand names
RotavacROTAVAC 5CROTAVAC5CROTAVAC-5CROTAVAC 5CMROTAVAC5CMROTAVAC-5CMROTAVAC 5DROTAVAC5DROTAVAC-5DROTAVAC®ROTAVAC®-20
Other names
Vero cell-based 116E neonatal rotavirus vaccine

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