rotavirus vaccine (Rotashield, Rotateq, Rotarix)

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[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18]

Introduction

Rotashield Approved in 1998, withdrawn from US market in 1999.

Rotateq FDA-approved 2006.

Indications

Contraindications

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

Mechanism of action

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]

More general terms

Additional terms

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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/16394299
    Glass RI & Parashur UD, N Engl J Med 2006; 354:75 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16394305
  3. ↑ Prescriber's Letter 13(4): 2006 FDA Approves New Vaccine to Prevent Rotavirus Gastroenteritis in Infants Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220410&pb=PRL (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#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=230318&pb=PRL (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. ↑ 6.0 6.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21992123 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1000446
  8. ↑ 8.0 8.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22012117 <Internet> http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6041a5.htm
  9. ↑ 9.0 9.1 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: https://www.ncbi.nlm.nih.gov/pubmed/21878425
    Glass RI. Unexpected benefits of rotavirus vaccination in the United States. J Infect Dis 2011 Oct 1; 204:975. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21878426
  10. ↑ 10.0 10.1 Shui IM et al Risk of Intussusception Following Administration of a Pentavalent Rotavirus Vaccine in US Infants JAMA. 2012;307(6):598-604 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22318281 <Internet> http://jama.ama-assn.org/content/307/6/598.short
  11. ↑ 11.0 11.1 11.2 Weintraub ES et al Risk of Intussusception after Monovalent Rotavirus Vaccination. N Engl J Med, Jan 14, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24422678 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24422676 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24422677 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1315836
  12. ↑ 12.0 12.1 Maglione MA et al Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review. Pediatrics; published online July 1, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25086160 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25086161 <Internet> 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26823540 <Internet> 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. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28328346 <Internet> 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. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28328339 <Internet> http://www.nejm.org/doi/10.1056/NEJMe1701347
  15. ↑ 15.0 15.1 Hofstetter AM, Lacombe K, Klein EJ et al. Risk of rotavirus nosocomial spread after inpatient pentavalent rotavirus vaccination. Pediatrics 2017 Dec 6. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29212881
  16. ↑ 16.0 16.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29466164 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1706804
  17. ↑ 17.0 17.1 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
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