Rotavirus vaccine
Drug Info:
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Rotavirus Vaccine
Brand names: RotaSheild®, RotaTeq®
- Drug Forms:
- Rotavirus Vaccine, live, oral, pentavalent solution (below)
- Rotavirus Vaccine, live, oral solution (Rotarix)
- Rotarix Oral suspension
- Rotavirus Pentavalent Live Vaccine Oral suspension
- Espa�ol:
- Solución oral de la vacuna contra el rotavirus
- Rotarix, Suspensión oral
- Vacuna viva pentavalente contra el rotavirus Suspensión oral
Rotavirus Vaccine, live, oral, pentavalent solution
What is rotavirus vaccine, live, oral, pentavalent solution?
What should I tell my health care provider before I take this medicine?
They need to know if you or your infant has any of these conditions:
• recent diarrhea or vomiting
• has not been gaining weight
• was born with stomach problems, has a blockage of the stomach, or has had stomach surgery
• has a blood disorder or has received a blood transfusion or blood products in the last 42 days
• an immune deficiency or a weakened immune system (natural or due to cancer, cancer chemotherapy, radiation, or steroid therapy) or a person with immune deficiency lives in your household
• fever or infection.
• HIV infection, or a person with HIV lives in your household
• an unusual or allergic reaction to rotavirus vaccine, other vaccines, other medicines, foods, dyes, or preservatives
• if you are pregnant or trying to get pregnant
• breast-feeding
How should I take this medicine?
Rotavirus vaccine is given to your infant by a health-care professional. The use of this vaccine must be officially recorded. Federal law requires that the manufacturer's name and lot number; name, address, and phone number of the person giving the vaccine; and the date of administration be recorded in the patient's permanent medical record. The vaccine solution will be administered directly into the infants mouth. The infant can have food or milk or can breast feed before or after the vaccine. This vaccine must never be given by injection, it is for use by mouth only.
Precautions for use in children: Use of oral rotavirus vaccine is not recommended in babies under 6 weeks old. Infants generally receive three doses, given between 6 weeks and 8 months of age.
Your health care professional will give you an informational paper on the rotavirus vaccine at the time of the vaccination. Be sure to read this information.
What drug(s) may interact with rotavirus vaccine, live, oral, pentavalent solution?
• immune globulin treatments
• medicines that suppress your immune function
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol; if you smoke; or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
Rotavirus vaccine does not interfere with some of the other vaccines that are commonly given in children, like diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate vaccine (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine. In some cases more than one type of vaccine can be given to your child at the same time. Ask your health care provider if you have questions regarding the administration of more than one vaccine to your child.
What should I watch for while taking rotavirus vaccine, live, oral, pentavalent solution?
Report any side effects to your prescriber or health care professional that do not go away within 3 days. There is a very small risk of passing the virus to someone else. Ask your health care professional about immunization for other family members.
A mild fever or cold by itself it not always reason to delay receiving the vaccine. Your health care provider will determine if it is appropriate for the vaccine to be given if a cold or mild fever is present.
After your infant has a dose of rotavirus vaccine, the virus from the vaccine can be shed in the infant's feces (stool) or from the infant's mouth. Avoid those who have a weakened immune system, or pregnant or breast-feeding women. Make sure you wash your hands well after going to the bathroom, or after changing a diaper for an infant that has received the vaccine.
What side effects may I notice from taking rotavirus vaccine, live, oral, pentavalent solution?
Side effects that you should report to your prescriber or health care professional immediately:
• blood in stools or changes in bowel movements
• diarrhea
• stomach pain
• vomiting
Side effects that you should report to your prescriber or health care professional as soon as possible:
• difficulty breathing, shortness of breath, wheezing, or coughing
• decreased activity
• decreased appetite, not wanting to breast-feed or take a bottle
• extreme irritability
• seizures (convulsions or strange movements of the arms or legs)
• severe rash, itching (hives)
• swelling of the eyes or face
• unusual or increased crying, or sudden change in alertness
• fever over 102 degrees F
Call your health care provider if any of these symptoms occur within 4 weeks of vaccination of your infant.
Side effects that usually do not require immediate medical attention (report these side effects to your prescriber or health care professional if they continue or are bothersome):
• mild fever, below 102 degrees F
Where can I keep my medicine?
Each dose of this vaccine will be administered in the clinic or office of a health care professional. You will not be given vaccine doses to store at home.
Last updated: 2/13/2006 12:18:00 PM
Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.
Wikipedia on Answers.com:
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Rotavirus vaccine
| Vaccine description | |
|---|---|
| Target disease | rotavirus |
| Type | Attenuated virus |
| Clinical data | |
| MedlinePlus | a607024 |
| Pregnancy cat. | ? |
| Legal status | ? |
| Routes | oral |
| Identifiers | |
| ATC code | J07BH02 |
 (what is this?) (verify) |
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A rotavirus vaccine protects children from rotaviruses, which are the leading cause of severe diarrhea among infants and young children.[1] Each year an estimated 453,000 children die from diarrhoeal disease caused by rotavirus,[2] most of whom live in developing countries,[3] and another two million are hospitalised.[4] 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.[5]
There are two effective rotavirus vaccines: Rotarix by GlaxoSmithKline and RotaTeq by Merck.[6]
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.[7]
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Contents
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History
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.[8]
In 2006, two vaccines against Rotavirus A infection were shown to be safe and effective in children: Rotarix by GlaxoSmithKline[9] and RotaTeq by Merck.[10] Both are taken orally and contain disabled live virus.
Rotarix
Rotarix is a human, live attenuated rotavirus vaccine containing a rotavirus strain of G1P[8] 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.[9] 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. Since there was a competing vaccine against diarrhea-causing rotavirus that free of this contamination (Merck's RotaTeq), the FDA decided to err on the side of caution. In May 2010 the suspension of the vaccine was lifted. [11]
RotaTeq
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.[12] 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.[13]
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 $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.[14]
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 the majority of rotavirus deaths occur.[15] A 2012 Cochrane review of 43 clinical trials that included 190,551 participants concluded Rotarix and RotaTeq are effective vaccines.[16] Additional rotavirus vaccines are under development.[17]
Rotavirus vaccines are licensed in more than 100 countries, but only 28[18] countries have introduced routine rotavirus vaccination.[19] The incidence and severity of rotavirus infections has declined significantly in countries that have acted on the recommendation to introduce the rotavirus vaccine.[20] In Mexico, which in 2006 was among the first countries in the world to introduce rotavirus vaccine, diarrheal disease death rates dropped during the 2009 rotavirus season by more than 65 percent among children age two and under.[21] In Nicaragua, which in 2006 became the first developing country to introduce rotavirus vaccine, investigators recorded substantial impact, with rotavirus vaccine preventing 60 percent of cases against severe rotavirus and cutting emergency room visits in half.[22] In the United States, rotavirus vaccination since 2006 has led to drops in rotavirus-related hospitalizations by as much as 86 percent. The vaccines may also have prevented illness in non-vaccinated children by limiting the number of circulating infections.[23]
References
- ^ Dennehy PH (2000). "Transmission of rotavirus and other enteric pathogens in the home". Pediatr. Infect. Dis. J. 19 (10 Suppl): S103–5. doi:10.1097/00006454-200010001-00003. PMID 11052397.
- ^ Tate JE, Burton AH, Boschi-Pinto C, Steele AD, Duque J, Parashar UD (February 2012). "2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis". Lancet Infect Dis 12 (2): 136–141. doi:10.1016/S1473-3099(11)70253-5. PMID 22030330.
- ^ World Health Organization (November 2008). "Global networks for surveillance of rotavirus gastroenteritis, 2001–2008". Weekly Epidemiological Record 47 (83): 421-424. http://www.who.int/wer/2008/wer8347.pdf. Retrieved 7 May 2012.
- ^ Simpson E, Wittet S, Bonilla J, Gamazina K, Cooley L, Winkler JL (2007). "Use of formative research in developing a knowledge translation approach to rotavirus vaccine introduction in developing countries". BMC Public Health 7: 281. doi:10.1186/1471-2458-7-281. PMC 2173895. PMID 17919334. http://www.biomedcentral.com/1471-2458/7/281.
- ^ Patel MM, Parashar UD, eds. (2011). "Real World Impact of Rotavirus Vaccination". Pediatric Infectious Disease Journal 30 (Supplement): S1-S66. http://journals.lww.com/pidj/toc/2011/01001. Retrieved 14 May 2012.
- ^ Soares-Weiser K, Maclehose H, Bergman H, et al. (2012). "Vaccines for preventing rotavirus diarrhoea: vaccines in use". Cochrane Database Syst Rev 2: CD008521. doi:10.1002/14651858.CD008521.pub2. PMID 22336845.
- ^ PATH's Rotavirus Vaccine Program
- ^ Bines J (2006). "Intussusception and rotavirus vaccines". Vaccine 24 (18): 3772–6. doi:10.1016/j.vaccine.2005.07.031. PMID 16099078.
- ^ a b O'Ryan M (2007). "Rotarix (RIX4414): an oral human rotavirus vaccine". Expert review of vaccines 6 (1): 11–9. doi:10.1586/14760584.6.1.11. PMID 17280473.
- ^ Matson DO (2006). "The pentavalent rotavirus vaccine, RotaTeq". Seminars in paediatric infectious diseases 17 (4): 195–9. doi:10.1053/j.spid.2006.08.005. PMID 17055370.
- ^ FDA's MedWatch Safety Alerts: May 2010 Rotarix Vaccine Suspension Lifted
- ^ "RotaTeq Is Approved In Canada" (Press release). Merck Frosst Canada. 2006-08-23. http://www.merckfrosst.ca/assets/en/pdf/press/product_info/rotateq/press_releases/Release_NATIONAL_CNW.pdf. Retrieved 2008-02-29.
- ^ McCarthy M (2003). "Project seeks to "fast track" rotavirus vaccine". Lancet 361 (9357): 582. doi:10.1016/S0140-6736(03)12549-4. PMID 12598149.
- ^ Rheingans RD, Antil L, Dreibelbis R, Podewils LJ, Bresee JS, Parashar UD (2009). "Economic costs of rotavirus gastroenteritis and cost-effectiveness of vaccination in developing countries". J Infect Dis 200 (Suppl 1): S16–27. doi:10.1086/605026. PMID 19817595.
- ^ World Health Organization (December 2009). "Rotavirus vaccines: an update". Weekly Epidemiological Record 51-52 (84): 533-540. http://www.who.int/wer/2009/wer8451_52.pdf. Retrieved 8 May 2012.
- ^ Soares-Weiser K, Maclehose H, Bergman H, et al. (2012). "Vaccines for preventing rotavirus diarrhoea: vaccines in use". Cochrane Database Syst Rev 2: CD008521. doi:10.1002/14651858.CD008521.pub2. PMID 22336845.
- ^ Ward RL, Clark HF, Offit PA (September 2010). "Influence of potential protective mechanisms on the development of live rotavirus vaccines". The Journal of Infectious Diseases 202 Suppl: S72–9. doi:10.1086/653549. PMID 20684721. http://www.jid.oxfordjournals.org/cgi/pmidlookup?view=long&pmid=20684721.
- ^ World Health Organization. "Global Immunization Data, March 2012". http://www.who.int/immunization_monitoring/Global_Immunization_Data.pdf. Retrieved 3 May 2012.
- ^ Widdowson MA, Steele D, Vojdani J, Wecker J, Parashar U (November 2009). "Global rotavirus surveillance: determining the need and measuring the impact of rotavirus vaccines". The Journal of Infectious Diseases 200 Suppl 1: S1–8. doi:10.1086/605061. PMID 19817589.
- ^ Giaquinto C, Dominiak-Felden G, Van Damme P, Myint TT, Maldonado YA, Spoulou V, Mast TC, Staat MA (July 2011). "Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: a systematic review of the experience in industrialized countries". Human Vaccines 7 (7): 734–48. doi:10.4161/hv.7.7.15511. PMID 21734466. http://www.landesbioscience.com/journals/hv/abstract.php?id=15511.
- ^ Richardson, V; Hernandez-Pichardo J, Quintanar-Solares M, et al. (2010). "Effect of Rotavirus Vaccination on Death From Childhood Diarrhea in Mexico". The New England Journal of Medicine 362 (4): 299-305. http://www.nejm.org/doi/full/10.1056/NEJMoa0905211. Retrieved 8 May 2012.
- ^ Patel, M; Pedreira C, De Oliviera L, et al. (2009). "Association Between Pentavalent Rotavirus Vaccine and Severe Rotavirus Diarrhea Among Children in Nicaragua". Journal of the American Medical Association 301 (21): 2243-2251. http://www.path.org/vaccineresources/details.php?i=831. Retrieved 8 May 2012.
- ^ Patel, MM; Parashar UD, eds. (January 2011). "Real World Impact of Rotavirus Vaccination". Pediatric Infectious Disease Journal 30 (Supplement). http://journals.lww.com/pidj/toc/2011/01001. Retrieved 8 May 2012.
External links
- DefeatDD.org
- National Clearinghouse Guideline: Prevention of rotavirus gastroenteritis among infants and children. Recommendations of the Advisory Committee on Immunization Practices (ACIP).
- PATH Rotavirus Vaccine Program
- Vaccine Information Statement from the US Centers for Disease Control and Prevention (as of December 1, 2007, available in English, Spanish, Somali, and Thai)
- Vaccine Resource Library: Rotavirus
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