Vaccine Safety Templates
Vaccine templates serve as standardized tools that incorporate essential factors for conducting a risk/benefit assessment of new vaccine candidates. Their primary objectives are:
- To facilitate communication of otherwise complex and highly technical data among key stakeholders and increase the transparency, comparability, and comprehension of essential information.
- To offer a practical checklist-like resource for effectively managing potential complex risks.
- To focus on key questions related to the essential safety and benefit-risk issues relevant for the intrinsic properties of the vaccine components. Below, you will find a comprehensive list of available standardized templates, as well as a selection of completed templates that have been utilized.
These have been developed with the collaboration of the Brighton Collaboration BRAVATO Working Group.
See the Brighton Collaboration standarized vaccine safety templates:
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid (RNA and DNA) vaccines.
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of inactivated viral vaccines
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines
Template for the Evaluation of Vaccines for Maternal Immunization
See the completed standarized templates:
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273).
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for a soluble glycoprotein vaccine to prevent disease caused by Nipah or Hendra viruses
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for an inactivated viral vaccine against Chikungunya virus
Vaccines based on the replication-deficient simian adenoviral vector ChAdOx1: Standardized template with key considerations for a risk/benefit assessment
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Medigen COVID-19 protein vaccine
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Novavax COVID-19 Vaccine (NVX-CoV2373), a recombinant spike protein vaccine with Matrix-M adjuvant to prevent disease caused by SARS-CoV-2 viruses
A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine
