Stability of heat stable, live attenuated Rotavirus vaccine (ROTASIIL®)

Vaccines currently available across the globe are stored and transported in a continuous cold-chain at 2-8 °C or below −20 °C. A temperature excursion outside this range affects the potency of the vaccines. Such vaccines need to be discarded leading wastage. The Rotavirus disease burden is predominantly reported in developing and low-income countries and therefore, has entered or poised to enter their national immunization programs. These countries already have several limitations for effective storage, maintenance and distribution of vaccines in a cold-chain and this introduction is expected to further stress this fragile ecosystem. To help mitigate the cold chain related issues, SIIPL has developed a thermostable rotavirus vaccine ROTASIIL® which can be stored at a temperature below 25 °C for 36 months, completely by-passing the standard 2-8 °C cold storages. In addition it has the capability to withstand temperatures of 37 °C and 40 °C for 18 months and short term exposure to 55 °C. It can also tolerate a temperature shock of being thawed from an extreme cold temperature of −20 °C to a high temperature of 42 °C. The vaccine contains serotypes G1, G2, G3, G4 and G9 (UK-Bovine reassortant strains procured from National Institute of Health-USA). The vaccine is recently licensed in India.