On October 01, 2018, the World Health Organization has prequalified the thermostable rotavirus vaccine, ROTASIILR manufactured by Serum Institute of India16.The vaccine which prevents severe rotavirus-induced diarrhea in infants, provides an innovative and affordable option to the global market as it is the first rotavirus vaccine that does not require constant refrigeration and will help meet the critical public health goal of improving vaccine supply worldwide.
The vaccine will now be available for procurement by United Nations agencies and Gavi, the Vaccine Alliance for use in low- and middle-income countries. This will help accelerate availability of the vaccine in countries experiencing the highest burden of rotavirus-induced diarrhea by providing a practical and affordable option for vaccine introduction.
ROTASIIL is Live Attenuated (Oral) pentavalent bovine vaccine indicated for active immunization of healthy infants from the age of 6 weeks for the prevention of gastroenteritis due to rotavirus infection when administered as a 3-dose series. The vaccine can last for months without refrigeration, which makes it far easier to use in remote villages with no electricity17.
Rotaviruses are contagious virus that can cause gastroenteritis symptoms including severe watery diarrhea, vomiting, fever, and abdominal pain. Infants and young children are most likely to get the rotavirus disease. According to WHO 2004 estimates, 527 000 children aged <5 years die each year from vaccine preventable rotavirus infections; most of these children live in low-income countries. Two brands, both oral, live, attenuated rotavirus vaccines, Rotarix and RotaTeq, are available internationally; and both vaccines are considered safe and effective in preventing gastrointestinal disease18.
Note - WHO prequalification of vaccines is a comprehensive assessment that takes place through a standardized procedure aimed at determining whether the product meets requirements for safety and efficacy in immunization programmes. The full prequalification assessment process includes the following components - Review of production process and quality control procedures; Laboratory testing; WHO site audit to manufacturing facilities with the responsible National Regulatory Authority.
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