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rotavirus vaccine (Rotashield, Rotateq, Rotarix)

Rotashield Approved in 1998, withdrawn from US market in 1999. Rotateq FDA-approved 2006. Indications: - prevention of rotavirus gastroenteritis in infants - may be some herd immunity effect [9] Contraindications: 1) anaphylaxis after a previous exposure to a rotavirus vaccine component 2) severe combined immunodeficiency (SCID) 3) intussusception [8] Dosage: - oral vaccine, 2 dose (RV1), 3 dose (RV5) - vaccinate infants at 2 & 4 months (RV1) - vaccinate infants at 2, 4 & 6 months (RV5) - 1st dose should be administered from age 6-14 weeks (maximum age for 1st dose is 14 weeks 6 days) - RV3-BB: 1st dose is 0-5 days of age (75% effective) [16] - RV3-BB 51% at 8-10 weeks of age - minimum interval between doses is 4 weeks - all doses should be administered by age 8 months Pharmacokinetics: - viral shedding may occur for 2 weeks after oral dose Adverse effects: - no increased risk of intussusception (Rotateq) [10] - newer vaccines linked to small but definite increase in intussusception risk (RR = 8.4) [11,12] - incidence is low 1 to 5 cases per 100,000 vaccinations, so absolute risk is low [11] - infection control practices may reduce risk for nosocomial spread of rotavirus administered to infants with prolonged hospital stays [15] Mechanism of action: - oral live virus vaccine Notes: - the FDA recommended temporarily suspending use of Rotarix (March 22, 2010) but then revised that recommendation to resume use of Rotarix (May 16, 2010) [6] - Rotavirus diagnoses declined after the vaccine introduced in 2006 [17]

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Rotavirus

General

live virus vaccine

References

  1. Prescriber's Letter 7(2):7, Feb. 2000
  2. Ruiz-Palacios GM et al, Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006; 354:11 PMID: 16394298 - Vesikari T et al Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006; 354:23 PMID: 16394299 - Glass RI & Parashur UD, N Engl J Med 2006; 354:75 PMID: 16394305
  3. Prescriber's Letter 13(4): 2006 FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants Detail-Document#: 220410 (subscription needed) http://www.prescribersletter.com http://www.fda.gov/bbs/topics/news/2006/NEW01307.html
  4. FDA Medwatch Twenty-eight (28) post-marketing reports of intussusception following administration of RotaTeq http://www.fda.gov/medwatch/safety/2007/safety07.htm#RotaTeq - Prescriber's Letter 14(3): 2007 RotaTeq and Intussusception Detail-Document#: 230318 (subscription needed) http://www.prescribersletter.com
  5. ACIP Provisional Recommendations for the Prevention of Rotavirus Gastroenteritis among Infants and Children http://www.cdc.gov/vaccines/recs/provisional/downloads/roto-7-1-08-508.pdf
  6. FDA MedWatch, 05/16/2010 Rotarix Vaccine: Update to Clinicians and Public Health Professionals http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205640.htm
  7. Cortes JE et al Rotavirus Vaccine and Health Care Utilization for Diarrhea in U.S. Children N Engl J Med 2011; 365:1108-1117 PMID: 21992123 http://www.nejm.org/doi/full/10.1056/NEJMoa1000446
  8. Centers for Disease Control and Prevention Addition of History of Intussusception as a Contraindication for Rotavirus Vaccination MMWR October 21, 2011 / 60(41);1427-1427 PMID: 22012117 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6041a5.htm
  9. Lopman BA et al. Infant rotavirus vaccination may provide indirect protection to older children and adults in the United States. J Infect Dis 2011 Oct 1; 204:980. PMID: 21878425 - Glass RI. Unexpected benefits of rotavirus vaccination in the United States. J Infect Dis 2011 Oct 1; 204:975. PMID: 21878426
  10. Shui IM et al Risk of Intussusception Following Administration of a Pentavalent Rotavirus Vaccine in US Infants JAMA. 2012;307(6):598-604 PMID: 22318281 http://jama.ama-assn.org/content/307/6/598.short
  11. Weintraub ES et al Risk of Intussusception after Monovalent Rotavirus Vaccination. N Engl J Med, Jan 14, 2014 PMID: 24422678 http://www.nejm.org/doi/full/10.1056/NEJMoa1311738 - Yih WK, Lieu TA, Kulldorff A et al Intussusception Risk after Rotavirus Vaccination in U.S. Infants. N Engl J Med, Jan 14, 2014 PMID: 24422676 http://www.nejm.org/doi/full/10.1056/NEJMoa1303164 - Glass RI and Parashar UD Rotavirus Vaccines - Balancing Intussusception Risks and Health Benefits. N Engl J Med, Jan 14, 2014 PMID: 24422677 http://www.nejm.org/doi/full/10.1056/NEJMe1315836
  12. Maglione MA et al Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review. Pediatrics; published online July 1, 2014 PMID: 25086160 http://pediatrics.aappublications.org/content/early/2014/06/26/peds.2014-1079.full.pdf+html - Byington CL Vaccines: Can Transparency Increase Confidence and Reduce Hesitancy? Pediatrics; published online July 1, 2014 PMID: 25086161 http://pediatrics.aappublications.org/content/early/2014/06/26/peds.2014-1494.full.pdf+html
  13. Libster R et al Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules. Pediatrics. February 2016, VOLUME 137 / ISSUE 2 PMID: 26823540 http://pediatrics.aappublications.org/content/137/2/1.33
  14. Sanaka S, Guindo O, Langendorf C et al. Efficacy of a low-cost, heat-stable oral rotavirus vaccine in Niger. N Engl J Med 2017 Mar 23; 376:1121. PMID: 28328346 http://www.nejm.org/doi/10.1056/NEJMoa1609462 - Santosham M, Steele D. Rotavirus vaccines - A new hope. N Engl J Med 2017 Mar 23; 376:1170. PMID: 28328339 http://www.nejm.org/doi/10.1056/NEJMe1701347
  15. Hofstetter AM, Lacombe K, Klein EJ et al. Risk of rotavirus nosocomial spread after inpatient pentavalent rotavirus vaccination. Pediatrics 2017 Dec 6. PMID: 29212881
  16. Bines JE, Thobari JA, Satria CD et al Human Neonatal Rotavirus Vaccine (RV3-BB) to Target Rotavirus from Birth. N Engl J Med 2018; 378:719-730. Feb 22, 2018 PMID: 29466164 http://www.nejm.org/doi/full/10.1056/NEJMoa1706804
  17. Hallowell BD, Parashar UD, Curns A, DeGroote NP, Tate JE. Trends in the Laboratory Detection of Rotavirus Before and After Implementation of Routine Rotavirus Vaccination - United States, 2000-2018. MMWR Morb Mortal Wkly Rep 2019;68:539-543. https://www.cdc.gov/mmwr/volumes/68/wr/mm6824a2.htm
  18. Rotarix package insert http://www.fda.gov/cber/label/rotarixLB.pdf