WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019

Rebecca Sheets ,Hye‐Na Kang ,Heidi Meyer ,Ivana Knežević

doi:10.1038/s41541-020-0197-2

Rebecca Sheets , Hye‐Na Kang + Show 2 more

Open Access

https://doi.org/10.1038/s41541-020-0197-2

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Journal: npj Vaccines	Publication Date: Jun 18, 2020
Citations: 4	License type: open-access

Affiliation: World Health Organization, Paul Ehrlich Institut

Abstract

Consultations have been held to promote the revision of the WHO guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines adopted by the Expert Committee on Biological Standardization (ECBS) in 2005. The drivers for this revision are described, including the need for regulatory convergence highlighted by the WHO R&D Blueprint. These consultations have driven the revision to its current form, where a new guideline that includes quality, nonclinical, and clinical evaluation of plasmid DNA vaccines is being prepared for public consultation with a view to present to an upcoming ECBS. Major changes to the guidelines include streamlining the existing quality (part A) and nonclinical (part B) sections to reflect the two decades of experience, with manufacturing and control, nonclinical evaluation, and clinical testing of plasmid DNA vaccines, as a platform technology. The urgency for gaining regulatory convergence on this topic is that development of such a platform technology as DNA vaccines for routine use immunizations will prepare manufacturers and regulators across the globe in dealing with rapid development of medical countermeasures against emerging infectious diseases even in the face of an emergency setting. Two examples are described of Zika candidate vaccines that have rapidly advanced in development based on preexisting nonclinical and clinical data that precluded the need to repeat nonclinical toxicology. This report describes the progress stemming from the most recent consultation on the guidelines, including topics discussed and consensus reached.

Highlights

Promoting regulatory convergence is recognized as a key enabler in the World Health Organization (WHO) R&D Blueprint
A number of regulatory gaps were identified and International Conference of Drug Regulatory Authorities (ICDRA) recommended WHO should ensure that regulatory support is a priority area of activity as the R&D Blueprint for emerging infectious diseases is implemented[1]
It was requested WHO should continue developing measurement and written standards that serve as a basis for regulatory evaluation taking into consideration: (1) priority pathogens defined by the Blueprint, and (2) a more flexible and dynamic approach to developing and establishing standards for quality, safety, and efficacy of products for use in PHEs2

Summary

INTRODUCTION

Promoting regulatory convergence is recognized as a key enabler in the World Health Organization (WHO) R&D Blueprint. She presented the informal consultation (December 2019) was to reach a her work on expressing monoclonal antibodies (mAb) in the consensus on the regulatory principles of the draft guidelines, plasmid DNA system Their anti-Zika candidate mAb has advanced discuss and identify any pending or critical issues such that an to the clinic, as well. One or more diseases, a novel vaccine candidate based on the ● It was agreed that the guidelines be revised based on the same technology but replacing only the antigen encoded to comments received Following revision and another round of match the emerging disease could permit rapid manufacturing, public consultation, the document will be discussed at the reduced (abbreviated) or waived requirements for nonclinical meeting of WHO ECBS in October 2020 for adoption.

DISCUSSION

Summary of preliminary outcomes

CONCLUSION AND WAY FORWARD