Vaccines in the Pipeline: The Path from Development to Use in the United States

Abstract

New vaccines in the United States go through a complex process on their path from development to the domestic market involving an intricate partnership of public and private agencies and organizations. This process includes licensure by the US Food and Drug Administration, the development of recommendations by the Advisory Committee on Immunization Practices, and safety oversight post-licensure. This article examines the roles of the US Food and Drug Administration and the Centers for Disease Control and Prevention as well as certain professional organizations in governing the testing, marketing, and usage of new vaccines. Vaccines currently in development to treat numerous infectious and noninfectious diseases are also examined and compared with frameworks of domestic vaccine development prioritization, past and present, as assessed by the Institute of Medicine.

Lessons Learned From Making and Implementing Vaccine Recommendations in the U.S.

“…Recent experience indicates they might have shorter duration of immunity, recommendations may be for more obscure indications or for narrower populations, and other classes of vaccines such as therapeutic vaccines may need to be considered. 49 There will be many new challenges because of the nature of vaccines on the horizon, not just because of the number. There will be more opportunities to use the lessons of the past and there will be future lessons to be learned in dealing with this increasingly complex playing field.…”

The history of the United States Advisory Committee on Immunization Practices (ACIP)

“…Research and technologies-including genomic sequencing of microbes and studies on cellular response to adjuvants-are contributing to creation of the next generation of vaccines [63], and candidate vaccines are being designed to protect not only against infectious diseasecausing organisms such as Staphylococcus aureus and Clostridium difficile but against non-infectious conditions such as obesity and certain types of cancer [64]. The ACIP is a critical component to the network of public-and private-sector entities that is crucial to harmonization of the immunization schedules in the future as vaccines continue to proliferate.…”

Vaccine and vaccination as a part of human life: In view of COVID‐19

“…As a result, activated CD4+ T‐cell incidents were assessed to evaluate immunogenicity of the newly developed vaccine candidate. [ 87 , 88 ]…”