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Review
. 2020 Jul 22;38(34):5556-5561.
doi: 10.1016/j.vaccine.2020.06.017. Epub 2020 Jun 19.

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid (RNA and DNA) vaccines

Denny Kim  1 , James S Robertson  2 , Jean-Louis Excler  3 , Richard C Condit  4 , Patricia E Fast  5 , Marc Gurwith  6 , George Pavlakis  7 , Thomas P Monath  8 , Jonathan Smith  9 , David Wood  2 , Emily R Smith  6 , Robert T Chen  6 , Sonali Kochhar  10 ; Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)
Affiliations
Review

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid (RNA and DNA) vaccines

Denny Kim et al. Vaccine. .

Abstract

Nucleic acid (DNA and RNA) vaccines are among the most advanced vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of nucleic acid vaccines. This will facilitate the assessment by key stakeholders of potential safety issues and understanding of overall benefit-risk. The structured assessment provided by the template can also help improve communication and public acceptance of licensed nucleic acid vaccines.

Keywords: Benefit-risk; Brighton Collaboration; CEPI; COVID-19; DNA; Nucleic acid; RNA; Safety; Template; Vaccine.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

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