Making vaccines “on demand”

Abstract

The integrated US Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has made great strides in strategic preparedness and response capabilities. There have been numerous advances in planning, biothreat countermeasure development, licensure, manufacturing, stockpiling and deployment. Increased biodefense surveillance capability has dramatically improved, while new tools and increased awareness have fostered rapid identification of new potential public health pathogens. Unfortunately, structural delays in vaccine design, development, manufacture, clinical testing and licensure processes remain significant obstacles to an effective national biodefense rapid response capability. This is particularly true for the very real threat of “novel pathogens” such as the avian-origin influenzas H7N9 and H5N1, and new coronaviruses such as hCoV-EMC. Conventional approaches to vaccine development, production, clinical testing and licensure are incompatible with the prompt deployment needed for an effective public health response. An alternative approach, proposed here, is to apply computational vaccine design tools and rapid production technologies that now make it possible to engineer vaccines for novel emerging pathogen and WMD biowarfare agent countermeasures in record time. These new tools have the potential to significantly reduce the time needed to design string-of-epitope vaccines for previously unknown pathogens. The design process—from genome to gene sequence, ready to insert in a DNA plasmid—can now be accomplished in less than 24 h. While these vaccines are by no means “standard,” the need for innovation in the vaccine design and production process is great. Should such vaccines be developed, their 60-d start-to-finish timeline would represent a 2-fold faster response than the current standard.

Keywords: :

• biothreat
• medical countermeasure
• H7N9
• H5N1
• SARS
• coronavirus
• immunoinformatics
• vaccine
• emerging infectious disease

Disclosure of potential conflicts of interest

ADG and WDM are senior officers and majority shareholders at EpiVax, Inc., a privately owned immunoinformatics and vaccine design company located in Providence, RI, USA. LM is an employee and holds stock options in EpiVax. LE and RWM have been paid consultants of EpiVax on vaccine development programs. JB and MC are employees and stockholders at Aldevron, Inc. The authors acknowledge that there is a potential conflict of interest related to their employment and attest that the work contained in this research report is free of any bias that might be associated with the commercial goals of the companies.

Acknowledgments

Funding to support the discussions leading to the development of the FastVax consortium can be attributed to the NIH U19 grant AI082642 (to ADG). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.

Endnote

^aThere are 276 clinical trials for “T cell vaccines” currently reported at http://www.cancer.gov/clinicaltrials/search.