Thematic review on vaccines
Principles of Vaccine Licensure, Approval, and Recommendations for Use

https://doi.org/10.1016/j.mayocp.2019.11.002Get rights and content

Abstract

The licensure and recommendation processes for vaccines are complex. In the United States, vaccines are licensed for the civilian and military populations on the basis of review of Biologics License Applications submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. For FDA-licensed vaccines, the product label includes indications, contraindications, and precautions for each vaccine. Package inserts do not include recommendations for vaccine use from the Advisory Committee on Immunization Practices (ACIP). The ACIP is chartered as a federal advisory committee to provide expert external advice and guidance to the director of the Centers for Disease Control and Prevention on the use of vaccines and related agents for control of vaccine preventable diseases in the civilian and military populations of the United States. As an external advisory committee to the Centers for Disease Control and Prevention, the ACIP has no regulatory authority but the committee does have responsibility for approving vaccines to be covered under the Vaccines for Children program. To implement ACIP vaccine recommendations in the public and private sectors, a collaboration of federal, state, and local governments as well as private organizations dealing with public health, vaccine supply, vaccine administration, vaccine finance, outcomes monitoring, public perception, and public trust and support must work together. Issues including vaccine misinformation, declining community immunity (herd protection), and need for risk communication add stress to this complex and fragile system. This study describes the functions of and interactions between FDA and ACIP.

Section snippets

Vaccine Licensure by the FDA

The Center for Biologics Evaluation and Research is the center within the FDA that is responsible for regulatory oversight of biologic products for human use including vaccine development as well as licensure of new vaccines in the United States.18,19,22 The mission of this center is to protect and enhance public health through regulation of biologic and related products including vaccines, blood, allergenics, tissues, and cellular and gene therapies. To obtain a US license, the product must be

Conclusion

Licensure of vaccines and implementation of recommendations that lead to vaccine uptake, community protection, and decrease in disease burden represent a complex system that requires collaboration in many areas of basic science, public health, vaccine delivery, outcomes monitoring, and public perception.

Acknowledgments

We appreciate the time, effort, and input on this manuscript from Dianne Miller and review by Susan Goldstein, MD.

This article is dedicated to Jean C. Smith, MD, who has worked tirelessly with the Advisory Committee on Immunization Practices to ensure that Food and Drug Administration–licensed vaccines are incorporated into the childhood/adolescent and/or adult vaccine schedules. Along the way, many of us have been educated by her thoughts and insight.

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    Potential Competing Interests: Dr Pickering is a board member of the Infectious Diseases Society of America (outside the submitted work). The other authors report no competing interests.

    Individual reprints of this article and a bound reprint of the entire Thematic Review on Vaccines will be available for purchase from our website www.mayoclinicproceedings.org.

    Thematic Reviews on Vaccines will continue in an upcoming issue.

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