rotavac,first indian designed vaccine to pass WHO

A new variant of rotavirus vaccine (ROTAVAC®) ROTAVAC 5D®, is the world’s first and only liquid formulation with lowest dosage form & can be stored at 2-8°C.
ROTAVAC 5D® is a monovalent vaccine containing suspension of live, naturally attenuated rotavirus neonatal 116E strain prepared in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of 0.5 mL ROTAVAC 5D® contains not less than [NLT] 105.0 FFU [Focus forming unit] of live rotavirus 116E & is administered in five drops as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age.

ROTAVAC 5D® is a unique rotavirus vaccine formulation that can be administered without buffer. Low dose facilitates easy vaccine logistics and cold chain management, and low biomedical waste disposal post-vaccination.

It can be stored at 2-8°C for up to 24 months. ROTAVAC 5D® confers similar clinical safety and immunogenicity profiles when compared to the WHO Prequalified ROTAVAC®. It is available in three different presentations, single-dose vial/pre-filled syringe and multi-dose vial. The available presentations and lowest dosage form makes it convenient and easy to adapt under Universal Immunization Programs (UIP) by countries.

Patient Product Information

Rotavac 5D® Brochure

ROTAVAC 5D® - Package Insert