Diarrhea is one of the leading causes of death among children globally. Rotavirus, the leading cause of severe childhood diarrhea, is found everywhere; however, children in developing countries with limited access to health care are most at risk. Good hygiene like hand-washing and cleanliness are important but are not enough to control the spread of the disease. The best way to protect children from this disease is through immunization.
The first vaccine for rotavirus, RotaShield, was licensed and recommended for routine childhood immunization in 1998. Wyeth Pharmaceuticals, however, withdrew the vaccine in 1999 due to safety concerns. Scientists associated the vaccine with a rare intestinal problem called intussusception, a potentially fatal telescoping of part of the bowel. No rotavirus vaccine was available until 2006, when the Advisory Committee on Immunization Practices recommended routine infant immunization with three doses of the recently licensed RotaTeq® vaccine, developed by H. Fred Clark, PhD, Stanley A. Plotkin, MD, and Paul A. Offit, MD. The Food and Drug Administration licensed another rotavirus vaccine, Rotarix®, for use in the United States in 2008. Rotarix® is given to infants in two doses. Both vaccines are given orally as drops.
Most children (about 9 out of 10) who get the vaccine will be protected from severe rotavirus disease. About 7 out of 10 children will be protected from rotavirus disease of any severity. There are currently two globally available vaccines against rotavirus: Merck’s RotaTeq® (a reassorted bovine-human rotavirus) and GlaxoSmithKline’s Rotarix® (derived from a single common strain of human rotavirus). Studies of these vaccines have demonstrated their safety and efficacy among children in every region of the world. Clinical efficacy trials in Africa and Asia found that the vaccines dramatically reduced severe disease among infants in developing countries, where most rotavirus deaths occur.
There are four orally administered rotavirus vaccines licensed for national markets only: ROTAVAC®, (naturally occurring bovine-human reassortant neonatal G9P, also called 116E) manufactured by Bharat Biotech, was licensed for use in India in 2014; ROTASIIL® (bovine-human reassortant with human G1, G2, G3 and G4 bovine UK G6P backbone), manufactured by Serum Institute of India, Pvt. Ltd., was licensed for use in India in 2016; Rotavin-M1®, manufactured by the Center for Research and Production of Vaccines, was licensed for use in Vietnam in 2007; and Lanzhou Lamb Rotavirus Vaccine, manufactured by the Lanzhou Institute of Biological Products, was licensed for use in China in 2000.
To date, more than 90 countries have introduced rotavirus vaccines in their national immunization programs. Gavi, the Vaccine Alliance, a global health partnership that works to increase access to vaccines, is supporting the introduction of rotavirus vaccines in many of the world’s poorest countries. More than 40 countries have introduced rotavirus vaccines with Gavi’s support. Rotavirus vaccines are an important part of an integrated prevention and treatment strategy to control diarrheal disease. Other elements of this strategy include oral rehydration therapy; zinc treatment; exclusive breastfeeding; proper nutrition; safe water; and improved sanitation and hygiene practices.