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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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    FIGURE 1.

    Steps from Concept through Approval of an Investigational Vaccine

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    TABLE 1.

    Phases of Clinical Evaluation of an Investigational Vaccine

    Phase Number and Type of Study ParticipantsScientific Questions Asked
    1 20 to 100 healthy adults
    • Is the vaccine safe?

    • Is the vaccine tolerable?

    • What are the vaccine side effects in relation to the dose administered?

    • Does the vaccine cause the desired immune response?

    2 Several hundred from target population
    • What is the desired vaccine dose and dosing interval?

    • Is the desired immune response to the vaccine achieved?

    • What are the common short-term vaccine side effects observed?

    3 Several hundred to tens of thousands from target population
    • How effective and safe is the vaccine when comparing people who receive the vaccine to people who do not receive the vaccine?

    • What are the most common side effects?

    • Is the safety and immune response in study participants consistent across different lots of vaccine manufactures?

    • What is the effect on safety and immune response when the vaccine is co-administered with other vaccines?

    • Source. Adapted from: Centers for Disease Control and Prevention: Vaccines. Parents. CDC.gov website. https://www.cdc.gov/vaccines/parents/infographics/journey-of-child-vaccine-h.pdf. Updated July 2018. Accessed December 12, 2020.

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North Carolina Medical Journal: 82 (2)
North Carolina Medical Journal
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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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    • Introduction
    • Vaccine Candidate Development
    • Vaccine Candidate Approval Process
    • Phased Testing
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  • Sidebar: A Rare Indication: Immunization Exemptions in North Carolina
  • We Have Met the Enemy, and He is Us: Falling Childhood Immunization Rates
  • North Carolina Has Strong Infrastructure to Get Even Better on Childhood Vaccines
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