A rotavirus vaccine is a
vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifi ...
used to protect against
rotavirus
Rotaviruses are the most common cause of diarrhea, diarrhoeal disease among infants and young children. Nearly every child in the world is infected with a rotavirus at least once by the age of five. Immunity (medical), Immunity develops with ...
infections, which are the leading cause of severe
diarrhea
Diarrhea (American English), also spelled diarrhoea or diarrhœa (British English), is the condition of having at least three loose, liquid, or watery bowel movements in a day. It often lasts for a few days and can result in dehydration d ...
among young children.
[ These vaccines prevent 15–34% of severe diarrhea in the ]developing world
A developing country is a sovereign state with a less-developed industrial base and a lower Human Development Index (HDI) relative to developed countries. However, this definition is not universally agreed upon. There is also no clear agreeme ...
and 37–96% of the risk of death among young children due to severe diarrhea.[ Immunizing babies decreases rates of rotavirus disease among older people and those who have not been immunized.]
The World Health Organization
The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
(WHO) recommends that rotavirus vaccine be included in national routine vaccinations
A vaccination schedule is a series of vaccinations, including the timing of all doses, which may be either recommended or compulsory, depending on the country of residence.
A vaccine is an antigenic preparation used to produce active immunity t ...
programs, especially in areas where the disease is common.[ This should be done along with promoting ]breastfeeding
Breastfeeding, also known as nursing, is the process where breast milk is fed to a child. Infants may suck the milk directly from the breast, or milk may be extracted with a Breast pump, pump and then fed to the infant. The World Health Orga ...
, handwashing, clean water, and good sanitation.[ They are given ]by mouth
Oral administration is a route of administration whereby a substance is taken through the Human mouth, mouth, swallowed, and then processed via the digestive system. This is a common route of administration for many medications.
Oral administ ...
and two or three doses are required.[ The approved vaccines are recommended.][ This includes their use in people with ]HIV/AIDS
The HIV, human immunodeficiency virus (HIV) is a retrovirus that attacks the immune system. Without treatment, it can lead to a spectrum of conditions including acquired immunodeficiency syndrome (AIDS). It is a Preventive healthcare, pr ...
.[ The vaccines are made with weakened][ rotavirus.
The currently licensed live oral vaccine first became available in the United States in 2006.] They are on the World Health Organization's List of Essential Medicines
The WHO Model List of Essential Medicines (aka Essential Medicines List or EML), published by the World Health Organization (WHO), contains the medications considered to be most effective and safe to meet the most important needs in a health s ...
. The vaccines are available in many countries.
Medical uses
Effectiveness
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 2021 Cochrane systematic review concluded that Rotavac, Rotateq, and Rotarix vaccines are safe and are effective at preventing diarrhea that is related to a rotavirus infection.
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 the European Union in 2006, and by the US FDA in April 2008. It is taken by mouth
Oral administration is a route of administration whereby a substance is taken through the Human mouth, mouth, swallowed, and then processed via the digestive system. This is a common route of administration for many medications.
Oral administ ...
.
Rotateq
Rotateq is a live, oral pentavalent vaccine A pentavalent vaccine combines five vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of ...
that contains five rotavirus strains produced by reassortment
Reassortment is the mixing of the genetic material of a species into new combinations in different individuals. The product of reassortment is called a reassortant. It is particularly used when two similar viruses that are infecting the same cell ...
. 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 US Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) approved Rotateq for use in the United States. In August 2006, Health Canada
Health Canada (HC; )Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary units, department of the Gove ...
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
The 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 pentavalent vaccine licensed for use in India in 2018. It contains human bovine reassortant strains of rotavirus serotypes G1, G2, G3, G4, and G9. This is the 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 Pharmaceuticals Inc. was a pharmaceutical company until it was purchased by Pfizer in 2009. The company was founded in Philadelphia, Pennsylvania, in 1860 as John Wyeth and Brother. Its headquarters moved to Collegeville, Pennsylvania, a ...
) was licensed for use in the United States. Clinical trials in the United States, Finland
Finland, officially the Republic of Finland, is a Nordic country in Northern Europe. It borders Sweden to the northwest, Norway to the north, and Russia to the east, with the Gulf of Bothnia to the west and the Gulf of Finland to the south, ...
, and Venezuela
Venezuela, officially the Bolivarian Republic of Venezuela, is a country on the northern coast of South America, consisting of a continental landmass and many Federal Dependencies of Venezuela, islands and islets in the Caribbean Sea. It com ...
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. However post-licensure studies conducted in the United States by Trudy Murphy and her colleagues at the Centers For Disease Control and Prevention (CDC) and Kramarz et al., found that Infants who received the vaccine were 30 times more likely to develop a severe form of bowel obstruction, called intussusception, during 3 to 7 days after the first dose than unvaccinated infants. The excess risk was estimated between one case in 5,000 to 10,000 vaccinees. Based on these data, the Advisory Committee on Immunization Practices (ACIP) withdrew its recommendation to use the vaccine, and the manufacturer of the vaccine withdrew it from the market in 1999. 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 (an acronym from its former name GlaxoSmithKline plc) is a British Multinational corporation, multinational Pharmaceutics, pharmaceutical and biotechnology company with headquarters in London. It was established in 2000 by a Mergers an ...
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 diarrhoea.
Society and culture
Economics
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.
More than 80 countries have introduced routine rotavirus vaccination, almost half with the support of Gavi, the Vaccine Alliance.
Temporary suspension in the US
In March 2010, the detection of DNA from porcine circovirus 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, Doctors, The Doctor or The Doctors may refer to:
Titles and occupations
* Physician, a medical practitioner
* Doctor (title), an academic title for the holder of a doctoral-level degree
** Doctorate
** List of doctoral degrees awarded ...
(MSF) developed a heat-stable version named BRV-PV. Phase 3 of the clinical trials was completed in Niger on 31 December 2020.
The vaccine has been associated with lower rates of type 1 diabetes
Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that occurs when the body's immune system destroys pancreatic cells (beta cells). In healthy persons, beta cells produce insulin. Insulin is a hormone require ...
.
References
Further reading
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External links
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