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The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines |
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| Affiliation: | 1. Global Healthcare Consulting, New Delhi, India;2. University of Washington, Seattle, WA, USA;3. Janssen Pharmaceuticals, Titusville, NJ, USA;4. International Vaccine Institute, Seoul, Republic of Korea;5. Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL, USA;6. Independent Adviser, UK;7. Independent Adviser, USA;8. Project Leader, CEPI, UK;9. International AIDS Vaccine Initiative, New York, NY, USA;10. Stanford School of Medicine, Palo Alto, CA, USA;11. Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA;12. Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany;13. University of Jordan, Amman, Jordan |
| Abstract: | Several protein vaccine candidates are among the COVID-19 vaccines in 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 protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines. |
| Keywords: | Brighton Collaboration CEPI COVID-19 Vaccine Benefit-risk Safety Protein Recombinant Peptide Template |
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