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Immunization Recommendations and Guidelines: From Development to CDC Recommendations

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Vaccine Science and Immunization Guideline

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Abstract

A vaccine’s journey from the bench to the guideline is a long and often unsuccessful process typically requiring an estimated half of a billion of dollars and over a decade of research and development. This chapter will review the process from the conception and early research and development, the clinical trials and manufacturing process, the licensing and approval process, and culminating with review and possible recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). The ACIP structure and process are shared including insight into GRADE process and how the committee develops a recommendation. A brief review of the post-licensure and recommendation monitoring including the Vaccine Adverse Event Reporting System is also included. Throughout the chapter are featured highlights illustrating the process and its challenges using familiar vaccines like Zika virus vaccine, influenza vaccine, meningitis b vaccine, and 9-valent human papillomavirus vaccine.

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References

  1. Serdobova I, Kieny M-P. Assembling a global vaccine development pipeline for infectious diseases in the developing world. Am J Public Health. 2006;96(9):1554–9.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Institute of Medicine (US) Committee on the Evaluation of Vaccine Purchase Financing in the United States. Financing vaccines in the 21st century: assuring access and availability. Washington, DC 2004. Available from: http://www.ncbi.nlm.nih.gov/books/NBK221811/

  3. Immunization Action Coalition. Manufacturer. Updated July 30, 2016. Available from: http://www.immunize.org/resources/manufact_vax.asp

  4. Services DoHaH. U.S. National vaccine plan. Updated October 4, 2016. Available from: http://www.hhs.gov/nvpo/national-vaccine-plan/index.html#

    Google Scholar 

  5. Organization WH. Research and development. Updated 2016. Available from: http://www.who.int/immunization/research/en/

  6. Organization WH. Disease-specific areas of work 2016. Updated 2016. Available from: http://www.who.int/immunization/research/development/en/

  7. Services USDoHH. National vaccine plan implementation 2010. Available from: http://www.hhs.gov/sites/default/files/nvpo/vacc_plan/2010-2015-Plan/implementationplan.pdf

  8. Press TNA. SMART vaccines: strategic multi-attribute ranking tool for vaccines 2015. Available from: https://www.nap.edu/smartvaccines/

  9. Anderson KB, Thomas SJ, Endy TP. The emergence of Zika virus a narrative review. Ann Intern Med. 2016;165(3):175–83.

    Article  PubMed  Google Scholar 

  10. National Institute of Allergy and Infectious Disease. Zika virus 2016. Available from: https://www.niaid.nih.gov/topics/zika/Pages/default.aspx

  11. Hennessey M, Fischer M, Staples JE. Zika virus spreads to new areas - region of the Americas, may 2015-january 2016. MMWR Morb Mortal Wkly Rep. 2016;65(3):55–8.

    Article  PubMed  Google Scholar 

  12. Disease NIoAaI. NIAID research approach to Zika virus 2016. Available from: https://www.niaid.nih.gov/topics/zika/researchapproach/Pages/default.aspx

  13. Disease NIoAaI. Zika virus vaccine research 2016. Available from: https://www.niaid.nih.gov/topics/Zika/ResearchApproach/Pages/vaccineResearch.aspx

  14. National Institute of Allergy and Infectious Disease. QUESTIONS AND ANSWERS: Phase 1 clinical trial of the NIAID Zika virus investigational DNA vaccine 2016. Available from: http://www.niaid.nih.gov/news/QA/Pages/Zika-DNA-Vaccine-QA.aspx

  15. Food and Drug Administration. About CBER 2016. Updated 5-31-2016. Available from: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123340.htm

  16. Administration FaD. Investigational new drug (IND) application 2016. Updated 8-1-2016. Available from: http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm

  17. Folaranmi T, Rubin L, Martin SW, Patel M, MacNeil JR. Use of serogroup B meningococcal vaccines in persons aged >/=10 years at increased risk for serogroup B meningococcal disease: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rept. 2015;64(22):608–12.

    Google Scholar 

  18. MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M, Martin SW. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the advisory committee on immunization practices, 2015. MMWR Morb Mortal Wkly Rept. 2015;64(41):1171–6.

    Article  Google Scholar 

  19. Administration FD. First vaccine approved by FDA to prevent serogroup B Meningococcal disease 2014. Updated 10/30/2014. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420998.htm

  20. Administration FaD. Vaccine product approval process 2015. Updated 8-24-2015. Available from: http://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologicslicenseapplicationsblaprocess/ucm133096.htm

  21. Administration FaD. Vaccines and related biological products advisory committee 2016. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/

  22. Administration FaD. Guidance for industry: FDA review of vaccine labeling requirements for warnings, use instructions, and precautionary information 2014. Updated 09/15/2014. Available from: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm074845.htm

  23. Administration FD. Vaccine product approval process. Updated 08/24/2015. Available from: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/ucm133096.htm

  24. Petrosky E, Bocchini JA Jr, Hariri S, Chesson H, Curtis CR, Saraiya M, et al. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rept. 2015;64(11):300–4.

    Google Scholar 

  25. Saraiya M, Unger ER, Thompson TD, Lynch CF, Hernandez BY, Lyu CW, et al. US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines. J Natl Cancer Inst. 2015;107(6):djv086.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Josefsberg JO, Buckland B. Vaccine process technology. Biotechnol Bioeng. 2012;109(6):1443–60.

    Article  CAS  PubMed  Google Scholar 

  27. Advisory Committee on Immunization Practices (ACIP). ACIP Charter 2016. Updated April 20, 2016. Available from: http://www.cdc.gov/vaccines/acip/committee/charter.html

  28. Grohskopf LA, Sokolow LZ, Olsen SJ, Bresee JS, Broder KR, Karron RA. Prevention and control of influenza with vaccines: recommendations of the advisory committee on immunization practices, United States, 2015-16 influenza season. MMWR Morb Mortal Wkly Rep. 2015;64(30):818–25.

    Article  PubMed  Google Scholar 

  29. Center for Disease Control and Prevention. ACIP votes down use of LAIV for 2016-2017 flu season 2016. Available from: http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

  30. Carter NJ, Curran MP. Live attenuated influenza vaccine (FluMist(R); Fluenz): a review of its use in the prevention of seasonal influenza in children and adults. Drugs. 2011;71(12):1591–622.

    Article  CAS  PubMed  Google Scholar 

  31. Appiah GD, Blanton L, D’Mello T, Kniss K, Smith S, Mustaquim D, et al. Influenza activity - United States, 2014-15 season and composition of the 2015-16 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2015;64(21):583–90.

    PubMed  Google Scholar 

  32. Caspard H, Gaglani M, Clipper L, Belongia EA, McLean HQ, Griffin MR, et al. Effectiveness of live attenuated influenza vaccine and inactivated influenza vaccine in children 2-17 years of age in 2013-2014 in the United States. Vaccine. 2016;34(1):77–82.

    Article  CAS  PubMed  Google Scholar 

  33. Food and Drug Administration. FDA information regarding FluMist Quadrivalent vaccine 2016. Updated 06/27/2016. Available from: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm508761.htm

  34. Tisa V, Barberis I, Faccio V, Paganino C, Trucchi C, Martini M, et al. Quadrivalent influenza vaccine: a new opportunity to reduce the influenza burden. J Prev Med Hyg. 2016;57(1):E28–33.

    CAS  PubMed  PubMed Central  Google Scholar 

  35. Center for Disease Control and Prevention. Vaccines for children program 2016. Available from: http://www.cdc.gov/vaccines/programs/vfc/index.html

  36. Department of Health and Human Services. Read the Law 2015. Updated August 28, 2015. Available from: http://www.hhs.gov/healthcare/about-the-law/read-the-law/

  37. Smith JC. The structure, role, and procedures of the U.S. advisory committee on immunization practices (ACIP). Vaccine. 2010;28(Suppl 1):A68–75.

    Article  PubMed  Google Scholar 

  38. Smith JC, Hinman AR, Pickering LK. History and evolution of the advisory committee on immunization practices--United States, 1964-2014. MMWR Morb Mortal Wkly Rep. 2014;63(42):955–8.

    PubMed  Google Scholar 

  39. Center for Disease Control and Prevention. ACIP Members July 1, 2015 - June 30, 2016. Updated 3-8-2016. Available from: http://www.cdc.gov/vaccines/acip/committee/members.html

  40. Smith JC, Snider DE, Pickering LK. Immunization policy development in the United States: the role of the advisory committee on immunization practices. Ann Intern Med. 2009;150(1):45–9.

    Article  PubMed  Google Scholar 

  41. Institute for Clinical Systems Improvement. Reviewing evidence using GRADE 2016. Available from: https://www.icsi.org/_asset/7mtqyr/ReviewingEvidenceUsingGRADE.pdf

  42. Guyatt GH, Oxman AD, Kunz R, Falck-Ytter Y, Vist GE, Liberati A, et al. Going from evidence to recommendations. BMJ. 2008;336(7652):1049–51.

    Article  PubMed  PubMed Central  Google Scholar 

  43. Centers for Disease Control and Prevention (CDC). New framework (GRADE) for development of evidence-based recommendations by the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep. 2012;61(18):327.

    Google Scholar 

  44. Schwartz JL. The first rotavirus vaccine and the politics of acceptable risk. Milbank Q. 2012;90(2):278–310.

    Article  PubMed  PubMed Central  Google Scholar 

  45. Department of Health and Human Services. VAERS: Vaccine Adverse Event Reporting System 2016. Available from: https://vaers.hhs.gov/index

  46. Organization WH. National passive surveillance. Available from: http://www.who.int/immunization/monitoring_surveillance/burden/vpd/surveillance_type/passive/en/

  47. The National Childhood Vaccine Injury Act of 1986 National Vaccine Information Center. Available from: http://www.nvic.org/injury-compensation/origihanlaw.aspx

  48. Federal Drug Administration. Postmarketing safety reporting requirements for drug and biologic products. Updated 03/09/2016. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm299833.htm

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Author information

Authors and Affiliations

  1. Department of Family & Community Medicine, Christiana Care Health System, Wilmington, DE, USA

    Margot Latrese Savoy MD, MPH, FAAFP, FABC, CPE, CMQ

Authors
  1. Margot Latrese Savoy MD, MPH, FAAFP, FABC, CPE, CMQ
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Correspondence to Margot Latrese Savoy MD, MPH, FAAFP, FABC, CPE, CMQ .

Editor information

Editors and Affiliations

  1. Department of Family Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA

    Pamela G. Rockwell, DO

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© 2017 Springer International Publishing AG

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Savoy, M.L. (2017). Immunization Recommendations and Guidelines: From Development to CDC Recommendations. In: Rockwell, DO, P. (eds) Vaccine Science and Immunization Guideline. Springer, Cham. https://doi.org/10.1007/978-3-319-60471-8_3

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  • DOI: https://doi.org/10.1007/978-3-319-60471-8_3

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-60470-1

  • Online ISBN: 978-3-319-60471-8

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