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A rotavirus vaccine protects children from rotaviruses, which are the leading cause of severe diarrhea among infants and young children. Each year an estimated 453,000 children die from diarrhoeal disease caused by rotavirus, most of whom live in developing countries, and another two million are hospitalised. Rotavirus is highly contagious and resistant and, regardless of water quality and available sanitation nearly every child in the world is at risk of infection.
On June 5, 2009, the World Health Organization (WHO) recommended that rotavirus vaccine be included in all national immunization programs. The Rotavirus Vaccine Program and the Accelerated Vaccine Introduction initiative have worked to study rotavirus vaccines among developing-country populations to assist developing countries in introducing rotavirus vaccines into routine immunization programs. These partnerships are spearheaded by international non-governmental organization PATH, WHO, the U.S. Centers for Disease Control and Prevention, and the Global Alliance for Vaccines and Immunization.
In 1998, a rotavirus vaccine (RotaShield, by Wyeth) was licensed for use in the United States. Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe diarrhea caused by rotavirus A, and researchers had detected no statistically significant serious adverse effects. The manufacturer of the vaccine, however, withdrew it from the market in 1999, after it was discovered that the vaccine may have contributed to an increased risk for intussusception, or bowel obstruction, in one of every 12,000 vaccinated infants. The experience provoked debate about the relative risks and benefits of a rotavirus vaccine.
In 2006, two vaccines against Rotavirus A infection were shown to be safe and effective in children: Rotarix by GlaxoSmithKline and RotaTeq by Merck. Both are taken orally and contain disabled live virus.
Rotarix is a human, live attenuated rotavirus vaccine containing a rotavirus strain of G1P specificity. ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series in infants and children. In March 2010 FDA officials urged pediatricians to temporarily stop using GlaxoSmithKline's Rotarix because they found it contaminated with fragments of DNA from porcine circovirus-1. Although this contamination was thought to be benign, vaccines are supposed to be sterile. In May 2010 the suspension of the vaccine was lifted. 
An Indian-made rotavirus vaccine Rotavac has demonstrated strong efficacy and excellent safety profile and if approved by the Drugs Controller General of India, it would be available at Rs. 54 per dose. This vaccine, developed under a public-private partnership, will be the third to hit the Indian market, but will be more affordable than the two vaccines now available costing more than Rs. 1,000 per dose. The clinical study has demonstrated for the first time that Rotavac is efficacious in preventing severe rotaviral diarrhoea in low-resource settings in India, and developing countries in Asia and Africa. Strain diversity, too, has not apparently affected its efficacy.
RotaTeq is a live, oral pentavalent vaccine that contains five rotaviruses produced by reassortment. The rotavirus A parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid, VP7, proteins (serotypes G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein VP4 (type P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein VP4, (type P1A), from the human rotavirus parent strain and the outer capsid protein VP7 (serotype G6) from the bovine rotavirus parent strain. In February 2006, the U.S. Food and Drug Administration approved RotaTeq for use in the United States. In August 2006, Health Canada approved RotaTeq for use in Canada. Merck is working with a range of partners including governmental and non-governmental organisations to develop and implement mechanisms for providing access to this vaccine in the developing world.
On March 22, 2010, the detection of DNA from porcine circovirus types 1 and 2 within RotaTeq prompted the FDA to suspend the use of rotavirus vaccines while conducting an investigation in collaboration with the 12 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). On May 6, 2010, the FDA announced its decision to revoke the suspension, asserting that porcine circovirus types 1 and 2 pose no safety risks in humans and concluded that health risks involved did not offset the benefits of the vaccination.
Effectiveness and cost
A 2009 review estimated that vaccination against rotavirus would prevent about 45% of deaths due to rotavirus gastroenteritis, or about 228,000 deaths annually worldwide. At $5 per dose the estimated cost per life saved was $3,015, $9,951 and $11,296 in low-, lower-middle-, and upper-middle-income countries, respectively. The cost of rotavirus vaccination has fallen by 67 percent between 2006 and 2011 to USD 2.50 per dose, as part of an offer made by a pharmaceutical company to the GAVI Alliance. However, the vaccine is still more expensive than most other childhood vaccines included in the WHO's Expanded Programme on Immunization.
Safety and efficacy trials of Rotarix and RotaTeq in Africa and Asia found that the vaccines dramatically reduced severe disease among infants in developing countries, where a majority of rotavirus-related deaths occur. A 2012 Cochrane review of 41 clinical trials that included 186,263 participants concluded Rotarix and RotaTeq are effective vaccines. Additional rotavirus vaccines are under development.
Rotavirus vaccines are licensed in more than 100 countries, but only 31 countries have introduced routine rotavirus vaccination as of 2011. The incidence and severity of rotavirus infections has declined significantly in countries that have acted on the recommendation to introduce the rotavirus vaccine. In Mexico, which in 2006 was among the first countries in the world to introduce rotavirus vaccine, the diarrheal disease death rates from rotavirus dropped by more than 65% among children age two and under during the 2009 rotavirus season . In Nicaragua, which in 2006 became the first developing country to introduce the rotavirus vaccine, investigators recorded a substantial impact, with rotavirus vaccine preventing 60% of cases against severe rotavirus and cutting emergency room visits in half. In the United States, vaccination has reduced rotavirus-related hospitalizations by as much as 86% since 2006. The vaccines may also prevent illness in non-vaccinated children by limiting exposure through the number of circulating infections. In September 2013, the vaccine will be offered to all children in the UK, aged between two and three months, and it is expected to halve the cases of severe infection and reduce the number of children admitted to hospital because of the infection by 70 percent.
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