Thematic review on vaccinesPrinciples of Vaccine Licensure, Approval, and Recommendations for Use
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.
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