Viral Vector Vaccines Safety Working Group (V3SWG)
In recognition of the increasing importance of viral vectors for the development of new vaccines and the need to understand their associated safety issues, the Brighton Collaboration (BC) created the Viral Vector Vaccines Safety Working Group (V3SWG) in October 2008. The V3SWG has two major activities:
1. Developing harmonized guidelines for assessing/addressing potential safety issues of concern for viral vector vaccines as listed in Table 1 of this paper.
2. Completing standardized templates with key considerations for a risk/benefit assessment on new viral vector vaccine candidates to: a) facilitate scientific discourse among key stakeholders by increasing the transparency and comparability of information; and b) provide a checklist like tool for managing potential complex risks. The template collects information on the characteristics of: a) the wild type virus from which the vector is derived; b) the viral vector itself before incorporation of the foreign antigen; and c) the final recombinant viral vector vaccine in animals and humans, toxicology and potency, with an overall adverse effect and risk assessment.
The template has been used for the standardized risk-assessment of several new viral vector vaccines, including some targeting Ebola (1, 5, 6, 7). The WHO Global Advisory Committee on Vaccine Safety (GACVS) endorsed the use of the template for other new candidate Ebola vaccines “as it is a structured approach to vaccine safety” (8, 9).
In 2020, the development of vaccines for COVID-19 is occurring with unprecedented speed. The pace and volume of development make a deliberate and systematic approach that is accessible and understandable to a diversity of stakeholders all the more important. Several DNA, RNA, protein subunit and live-attenuated vaccine candidates are among the COVID-19 vaccines in development. The BC V3SWG has therefore developed specific templates, such as for nucleic acid and protein subunit vaccines, that the Coalition for Epidemic Preparedness Innovations (CEPI) and other key stakeholders will use to evaluate and communicate the benefit-risk of vaccines using these platforms. Below are links to the latest versions of each template in two forms: 1) the full “publication version”, including all introductory text and formatted for publication; and 2) the shorter and more easily updatable “website version”, formatted for easy completion and with extraneous text removed. Templates under development will be added once completed.
- Viral vector template
- Publication version
- Website Version
- Template revisions
- This document provides a summary of the three major version changes.
- Version 1 to Version 2 translation document
- This document provides a list of the vector template changes between the original Version 1 template and most updated Version 2 template. Changes are listed by template section.
- Chinese Translation
- Nucleic acid template
- Protein subunit template
- Inactivated template (under development)
- Live-attenuated template (under development)
- Maternal immunization module (under development)
The V3SWG hopes that eventually all developers/researchers of
viral vector vaccines (especially those likely to be used in humans in the near future) will complete the relevant template and submit it to the V3SWG and BC for peer review and eventual publication in Vaccine. Following this, to promote transparency, the template will be posted and maintained on the BC website for use/reference by various stakeholders. Furthermore, recognizing the rapid pace of new scientific developments in this domain (relative to case definitions for adverse events following immunization), these completed templates can be updated with the help of each vector vaccine “community.” The science and the evidence contained in each published template (see: “Relevant publications (Activity 2 – Templates)” below) is constantly evolving. If you have a suggestion for an edit, please provide it using the form found at the bottom of this page.
Relevant publications (Activity 1 – Guidelines):
1. Robert T. Chen, Baevin Carbery, Lisa Mac, et al., The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG), Vaccine, Volume 33, Issue 1, 2015, Pages 73-75, https://doi.org/10.1016/j.vaccine.2014.09.035
2. Richard C. Condit, Anna-Lise Williamson, Rebecca Sheets, et al.,
Unique safety issues associated with virus-vectored vaccines: Potential for and theoretical consequences of recombination with wild type virus strains, Vaccine, Volume 34, Issue 51, 2016, Pages 6610-6616, https://doi.org/10.1016/j.vaccine.2016.04.060
3. Bettina Klug, James S. Robertson, Richard C. Condit, et al., Adventitious agents and live viral vectored vaccines: Considerations for archiving samples of biological materials for retrospective analysis, Vaccine, Volume 34, Issue 51, 2016, Pages 6617-6625, https://doi.org/10.1016/j.vaccine.2016.02.015
4. Sonali Kochhar, Jean-Louis Excler, Karin Bok, et al., Defining the interval for monitoring potential adverse events following immunization (AEFIs) after receipt of live viral vectored vaccines, Vaccine, Volume 37, Issue 38, 2019, Pages 5796-5802, https://doi.org/10.1016/j.vaccine.2018.08.085
Relevant publications (Activity 2 – Templates):
5. Thomas P. Monath, Stephen J. Seligman, James S. Robertson, et al., Live virus vaccines based on a yellow fever vaccine backbone: Standardized template with key considerations for a risk/benefit assessment, Vaccine, Volume 33, Issue 1, 2015, Pages 62-72, https://doi.org/10.1016/j.vaccine.2014.10.004
6. David K. Clarke, R. Michael Hendry, Vidisha Singh, et al., Live virus vaccines based on a vesicular stomatitis virus (VSV) backbone: Standardized template with key considerations for a risk/benefit assessment, Vaccine, Volume 34, Issue 51, 2016, Pages 6597-6609, https://doi.org/10.1016/j.vaccine.2016.06.071
7. Thomas P. Monath, Patricia E. Fast, Kayvon Modjarrad, et al., rVSVΔG-ZEBOV-GP (also designated V920) recombinant vesicular stomatitis virus pseudotyped with Ebola Zaire Glycoprotein: Standardized template with key considerations for a risk/benefit assessment, Vaccine: X, Volume 1, 2019, 100009, https://doi.org/10.1016/j.jvacx.2019.100
Other published mentions of the template: