An overview of FDA-approved vaccines & their innovators

ABSTRACT

Introduction: A survey of FDA-approved biologicals focused upon the development of immunotherapies over time to gain insight on the challenges and trends of vaccine development today.

Areas covered: A total of 135 different immune-based therapies were broadly divided into passive or active immunotherapies. Whereas just over half of passive immunotherapies targeted infectious diseases, the vast majority of active immunotherapy products (vaccines) were directed against a handful of viral and bacterial pathogens. We also analyze changes in vaccine strategy, including the use of viable antigens and subunit approaches.

Expert commentary: An analysis of vaccine innovators revealed an ever-increasing presence of the private sector and a relatively diminishing role for the public sector . Whereas North American companies have contributed to the approval of two-thirds of vaccines, European companies have regained parity in terms of hosting innovators of vaccine research and development.

KEYWORDS:

• Pathogens
• vaccine development
• vaccine innovation
• passive immunization
• active immunization

Acknowledgments

The authors would like to thank Dr. George Kemble for expert advice and guidance.

Declaration of interest

RH Griesenauer is supported by an NIH Ruth L. Kirschstein National Research Service Award. (TL1 TR000449). MS Kinch is supported by the Center for Research Innovation and Biotechnology and Washington University, St. Louis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

The manuscript was supported by a National Institutes of Health, National Center for Advancing Translational Sciences grant (TL1TR002344).