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Rotavirus vaccine

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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
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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]

Contents

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. In May 2010 the suspension of the vaccine was lifted. [11]

Rotavac

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.[12]

RotaTeq

H. Fred Clark and Paul Offit, the inventors of 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.[13] 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.[14]

Temporary suspension

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).[15] 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.[15]

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.[16] The cost of rotavirus vaccination has fallen by 67 percent between 2006 and 2011 to USD 2.50 per dose,[17] 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.[18]

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.[19] A 2012 Cochrane review of 41 clinical trials that included 186,263 participants concluded Rotarix and RotaTeq are effective vaccines.[6] Additional rotavirus vaccines are under development.[20]

Rotavirus vaccines are licensed in more than 100 countries, but only 31[21] countries have introduced routine rotavirus vaccination as of 2011.[22] The incidence and severity of rotavirus infections has declined significantly in countries that have acted on the recommendation to introduce the rotavirus vaccine.[23] 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 .[24] 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.[25] 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.[5] 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.[26]

References

  1. ^ 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.
  2. ^ 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.
  3. ^ World Health Organization (November 2008). "Global networks for surveillance of rotavirus gastroenteritis, 2001-200" (PDF). Wkly. Epidemiol. Rec. 83 (47): 421–5. PMID 19024780.
  4. ^ 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.
  5. ^ a b Patel MM, Steele D, Gentsch JR, Wecker J, Glass RI, Parashar UD (January 2011). "Real-world impact of rotavirus vaccination". Pediatr. Infect. Dis. J. 30 (1 Suppl): S1–5. doi:10.1097/INF.0b013e3181fefa1f. PMID 21183833.
  6. ^ a b Soares-Weiser K, Maclehose H, Bergman H, et al. (2012). "Vaccines for preventing rotavirus diarrhoea: vaccines in use". Cochrane Database Syst Rev 11: CD008521. doi:10.1002/14651858.CD008521.pub3. PMID 23152260.
  7. ^ PATH's Rotavirus Vaccine Program
  8. ^ Bines J (2006). "Intussusception and rotavirus vaccines". Vaccine 24 (18): 3772–6. doi:10.1016/j.vaccine.2005.07.031. PMID 16099078.
  9. ^ 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.
  10. ^ 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.
  11. ^ FDA's MedWatch Safety Alerts: May 2010 Rotarix Vaccine Suspension Lifted
  12. ^ The Hindu News about Rotavac
  13. ^ "RotaTeq Is Approved In Canada" (Press release). Merck Frosst Canada. 2006-08-23. Retrieved 2008-02-29.
  14. ^ McCarthy M (2003). "Project seeks to "fast track" rotavirus vaccine". Lancet 361 (9357): 582. doi:10.1016/S0140-6736(03)12549-4. PMID 12598149.
  15. ^ a b U.S. Food and Drug Administration. "Update on Recommendations for the Use of Rotavirus Vaccines". Retrieved 13 July 2012.
  16. ^ 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.
  17. ^ Berkley, Seth (12 April 2013). "Beating the Child Killers". Project Syndicate. Retrieved 17 April 2013.
  18. ^ Madsen, Lizell B; Marte Ustrup, Thea K Fischer, C Bygbjerg & Flemming Konradsen (18 January 2012). "Reduced price on rotavirus vaccines: enough to facilitate access where most needed?". Bulletin of the World Health Organization 90: 554-556. doi:10.2471/BLT.11.094656. Retrieved 17 April 2013.
  19. ^ World Health Organization (December 2009). "Rotavirus vaccines: an update" (PDF). Wkly. Epidemiol. Rec. 51-52 (84): 533–540.
  20. ^ 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.
  21. ^ World Health Organization. "Global Immunization Data, March 2012". Retrieved 3 May 2012.
  22. ^ 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.
  23. ^ 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.
  24. ^ Richardson V, Hernandez-Pichardo J, Quintanar-Solares M, et al. (January 2010). "Effect of rotavirus vaccination on death from childhood diarrhea in Mexico". N. Engl. J. Med. 362 (4): 299–305. doi:10.1056/NEJMoa0905211. PMID 20107215.
  25. ^ Patel M, Pedreira C, De Oliveira LH, et al. (June 2009). "Association between pentavalent rotavirus vaccine and severe rotavirus diarrhea among children in Nicaragua". JAMA 301 (21): 2243–51. doi:10.1001/jama.2009.756. PMID 19491186.
  26. ^ UK Department of Health:New vaccine to help protect babies against rotavirus. Retrieved on 10 November, 2012

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