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 Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO), 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. 

BRAVATO (formerly V3SWG) had earlier published a standardized template describing the key considerations for a risk-benefit assessment of new viral vaccines and their vectors. The template has been used for the standardized risk-assessment of several new viral vector vaccines, including some targeting Ebola (15678, 910, 12). 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” (1314).

Individuals who are interested in joining BRAVATO or participating in affiliated activities are welcome to contact bc-coordinator@taskforce.org for possible membership.

Below are links to the latest versions of the nucleic acid 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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