Standardized Template for Collection of Key Information for Risk/Benefit Assessment of Nucleic Acid (RNA and DNA) Vaccines

The COVID-19 pandemic has devastated the world as we know it. Nucleic acid (DNA and RNA) vaccines are among the most advanced vaccines for COVID-19 under development. These vaccine technology platforms are relatively new to many key stakeholders in the immunization domain, however, especially from low and middle-income countries. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) as part of the Safety Platform for Emergency Vaccines (SPEAC) project has therefore prepared a standardized template to describe the key considerations for the risk-benefit assessment of nucleic acid vaccines. We anticipate its completion and use by the Coalition for Epidemic Preparedness Innovations (CEPI) awardees, the World Health Organization, and other key stakeholders to anticipate potential safety issues and interpret or assess safety data. This in turn would help improve communication and public acceptance when the nucleic acid vaccines are licensed. The V3SWG is also developing standard templates for protein, inactivated, and live attenuated vaccines. Please note that Version 2, an update from the original Version 1 of the V3SWG viral vector template, is also now available; as is a translation document listing changes between Version 1 and Version 2 of the template, and the rationale for the changes.

Individuals who are interested in joining the V3SWG or participating in affiliated activities are welcome to contact the working group secretariat (brightoncollaborationv3swg@gmail.com) for possible membership in the V3SWG.

Below are links to the latest versions of the 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.

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