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Rotavirus vaccine is a vaccine used to protect against rotavirus infections, which are the leading cause of severe
diarrhea Diarrhea, also spelled diarrhoea, is the condition of having at least three loose, liquid, or watery bowel movements each day. It often lasts for a few days and can result in dehydration due to fluid loss. Signs of dehydration often begin wi ...
among young children. The vaccines prevent 15–34% of severe diarrhea in the developing world and 37–96% of severe the risk of death among young children due to diarrhea. Immunizing babies decreases rates of disease among older people and those who have not been immunized. The World Health Organization (WHO) recommends that rotavirus vaccine be included in national routine vaccinations programs, especially in areas where the disease is common. This should be done along with promoting
breastfeeding Breastfeeding, or nursing, is the process by which human breast milk is fed to a child. Breast milk may be from the breast, or may be expressed by hand or pumped and fed to the infant. The World Health Organization (WHO) recommends that brea ...
, handwashing, clean water, and good sanitation. It is given
by mouth Oral administration is a route of administration where a substance is taken through the mouth. Per os abbreviated to P.O. is sometimes used as a direction for medication to be taken orally. Many medications are taken orally because they are in ...
and requires two or three doses. It should be given starting around six weeks of age. The vaccines are safe. This includes their use in people with HIV/AIDS. The vaccines are made from weakened rotavirus. The vaccine first became available in the United States in 2006. It is on the World Health Organization's List of Essential Medicines. As of 2013, there are two types of vaccine available globally, Rotarix and RotaTeq. Others are used in some countries.


Medical uses


Effectiveness

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 US$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. Safety and efficacy trials 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 2019 Cochrane review concluded that RV1, RV5, and Rotavac vaccines are safe and are effective at preventing diarrhea. Rotavirus vaccines are licensed in more than 100 countries, and more than 80 countries have introduced routine rotavirus vaccination. 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. In April 2016, the World Health Organization released statistics for the period of 2000–2013, which showed developing countries that have introduced rotavirus vaccines experienced significant decreases in deaths and hospitalizations from rotavirus diarrhea after introduction. Additionally, the vaccines may also prevent illness in non-vaccinated children by limiting exposure through the number of circulating infections. A 2014 review of available clinical trial data from countries routinely using rotavirus vaccines in their national immunization programs found that rotavirus vaccines have reduced rotavirus hospitalizations by 49–92% and all-cause diarrhea hospitalizations by 17–55%.


Schedule

The World Health Organization recommends the first dose of vaccine be given right after six weeks of age.


Types


Rotarix

Rotarix is a monovalent, human, live attenuated rotavirus vaccine containing one 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. It was approved in Europe in 2006 and by the U.S. FDA in April 2008. It is administered by mouth.


RotaTeq

RotaTeq is a live, oral pentavalent vaccine that contains five rotavirus strains produced by reassortment. The rotavirusA 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 The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
approved RotaTeq for use in the United States. In August 2006,
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the department of the Government of Canada responsible for national health polic ...
approved RotaTeq for use in Canada. Merck worked 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, an effort which was slated to come to an end in 2020.


Rotavac

Rotavac was licensed for use in India in 2014, and is manufactured by Bharat Biotech International Limited. It is a live attenuated, monovalent vaccine containing a G9P 1human strain isolated from an Indian child. It is given by mouth in a three-dose series, four weeks apart, beginning at six weeks of age up until eight months of age.


Rotavin-M1

Rotavin-M1 was licensed for use in Vietnam in 2007, and is manufactured by the Center for Research and Production of Vaccines. The vaccine contains a G1P human rotavirus strain.


Lanzhou lamb

Lanzhou lamb rotavirus vaccine was licensed for use in China in 2000, and is manufactured by the Lanzhou Institute of Biological Products. It contains a G10P 2lamb rotavirus strain.


Rotasiil

Rotasiil is a
lyophilized Freeze drying, also known as lyophilization or cryodesiccation, is a low temperature dehydration process that involves freezing the product and lowering pressure, removing the ice by sublimation. This is in contrast to dehydration by most conve ...
pentavalent vaccine licensed for use in India in 2018. It contain human bovine reassortant strains of rotavirus serotypes G1, G2, G3, G4 and G9. This is world's first thermostable vaccine which can be stored without refrigeration at or below 25 °C. Rotasiil is manufactured by the Serum Institute of India.


History

In 1998, a rotavirus vaccine (RotaShield, by
Wyeth Wyeth, LLC was an American pharmaceutical company. The company was founded in Philadelphia, Pennsylvania, in 1860 as ''John Wyeth and Brother''. It was later known, in the early 1930s, as American Home Products, before being renamed to Wyeth in ...
) 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 rotavirusA, 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. There then followed eight years of delay until rival manufacturers were able to introduce new vaccines that were shown to be more safe and effective in children: Rotarix by
GlaxoSmithKline GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the tent ...
and RotaTeq by Merck. Both are taken orally and contain disabled live virus. The World Health Organization recommends that rotavirus vaccine be included in all national immunization schedules because the risk of intussusception following rotavirus vaccination remains very low compared with the benefits of preventing the impact of severe and deadly diarrhea.


Society and culture

More than 80 countries have introduced routine rotavirus vaccination, almost half with the support of
Gavi, the Vaccine Alliance GAVI, officially Gavi, the Vaccine Alliance (previously the GAVI Alliance, and before that the Global Alliance for Vaccines and Immunization) is a public–private global health partnership with the goal of increasing access to immunization ...
. In order to make rotavirus vaccines available, accessible, and affordable in all countries—particularly low- and middle-income countries in Africa and Asia where the majority of rotavirus deaths occur—international non-governmental organization PATH, the WHO, the U.S.
Centers for Disease Control and Prevention The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georg ...
(CDC), and Gavi have partnered with research institutions and governments to generate and disseminate evidence, lower prices, and accelerate introduction. These and other organizations continue to work to improve coverage and public health impact of rotavirus vaccination today.


Temporary suspension in the US

On 22 March 2010, the detection of DNA from
porcine circovirus Porcine circovirus (PCV) is a group of four single-stranded DNA viruses that are non-enveloped with an unsegmented circular genome. They are members of the genus '' Circovirus'' that can infect pigs. The viral capsid is icosahedral and approxim ...
types 1 and 2 within RotaTeq and Rotarix prompted the FDA to suspend the use of rotavirus vaccines while conducting an investigation the finding of DNA from porcine circovirus-1 (PCV1) in the vaccine in collaboration with the 12 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). On 6 May 2010, the FDA announced its decision to revoke the suspension, stating 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. In May 2010 the suspension of the Rotarix vaccine was lifted.


Research

Doctors Without Borders Doctor or The Doctor may refer to: Personal titles * Doctor (title), the holder of an accredited academic degree * A medical practitioner, including: ** Physician ** Surgeon ** Dentist ** Veterinary physician ** Optometrist *Other roles ** ...
(MSF) developed a heat-stable version named BRV-PV. Phase 3 of the clinical trials were completed in Niger on 31 December 2020. The vaccine has been associated with lower rates of type 1 diabetes.


References


Further reading

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External links

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Rotavirus
Vaccine Resource Library
Rotavirus
ROTA Council * {{DEFAULTSORT:Rotavirus Vaccine Gastroenterology Live vaccines Rotaviruses Merck & Co. brands Vaccines Viral diseases Wikipedia medicine articles ready to translate World Health Organization essential medicines (vaccines) fr:Rotavirus#Vaccins