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Research ArticleINVITED COMMENTARIES AND SIDEBARS

Vaccine Development: Steps to Approval of an Investigational Vaccine

Emmanuel B. Walter and M. Anthony Moody
North Carolina Medical Journal March 2021, 82 (2) 141-144; DOI: https://doi.org/10.18043/ncm.82.2.141
Emmanuel B. Walter
Professor, Department of Pediatrics and chief medical officer, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina.
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  • For correspondence: chip.walter@duke.edu
M. Anthony Moody
Associate professor, Department of Pediatrics and research quality officer, Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina.
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References

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    . Ten great public health achievements—United States, 1900-1999. MMWR Morb Mortal Wkly Rep. 1999;48(12):241-243.
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    1. US Food and Drug Administration
    . Classification of Products as Drugs and Devices and Additional Product Classification Issues. FDA website. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues#drug. Published September 2017. Accessed October 22, 2020.
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    1. US Food and Drug Administration
    . What Are “Biologics” Questions and Answers. https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics-questions-and-answers. Published February 6, 2018. Accessed October 22, 2020.
  5. 5.↵
    Public Health: Immunization required, § 130A-152 (1957, 2007).
  6. 6.↵
    1. Marshall V,
    2. Baylor NW.
    Food and Drug Administration regulation and evaluation of vaccines. Pediatrics. 2011;127(suppl 1):S23-S30. doi: 10.1542/peds.2010-1722E
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  7. 7.↵
    1. Preiss S,
    2. Garçon N,
    3. Cunningham AL,
    4. Strugnell R,
    5. Friedland LR.
    Vaccine provision: Delivering sustained & widespread use. Vaccine. 2016;34(52):6665-6671. doi: 10.1016/j.vaccine.2016.10.079
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    1. Plotkin SA.
    Correlates of protection induced by vaccination. Clin Vaccine Immunol. 2010;17(7):1055-1065. doi: 10.1128/CVI.00131-10
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    1. US Food and Drug Administration
    . Biologics License Applications (BLA) Process (CBER). https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber. Updated November 20, 2020. Accessed October 22, 2020.
  10. 10.↵
    1. Pickering LK,
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    3. Orenstein WA,
    4. Cohn AC.
    Principles of vaccine licensure, approval, and recommendations for use. Mayo Clin Proc. 2020;95(3):600-608. doi: 10.1016/j.mayocp.2019.11.002
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    1. US Food and Drug Administration
    . Postmarketing Requirements and Commitments: Introduction. https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments. Published January 12, 2016. Accessed October 22, 2020.
  12. 12.↵
    1. US Department of Health & Human Services: Vaccines
    . Vaccine Safety. Vaccines.gov website. https://www.vaccines.gov/basics/safety. Updated February 2020. Accessed October 22, 2020.
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North Carolina Medical Journal: 82 (2)
North Carolina Medical Journal
Vol. 82, Issue 2
March-April 2021
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Vaccine Development: Steps to Approval of an Investigational Vaccine
Emmanuel B. Walter, M. Anthony Moody
North Carolina Medical Journal Mar 2021, 82 (2) 141-144; DOI: 10.18043/ncm.82.2.141

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Vaccine Development: Steps to Approval of an Investigational Vaccine
Emmanuel B. Walter, M. Anthony Moody
North Carolina Medical Journal Mar 2021, 82 (2) 141-144; DOI: 10.18043/ncm.82.2.141
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  • Article
    • Introduction
    • Vaccine Candidate Development
    • Vaccine Candidate Approval Process
    • Phased Testing
    • Distribution and Continued Evaluation
    • Acknowledgments
    • References
  • Figures & Data
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More in this TOC Section

  • Sidebar: Community-driven Approaches to Preventing Overdoses Among American Indians
  • Sidebar: History Shaping the Future: How History Influences Health in North Carolina Native American Communities
  • Sidebar: Impact of Racial Misclassification of Health Data on American Indians in North Carolina
Show more INVITED COMMENTARIES AND SIDEBARS

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