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SWAT Team Description: The Clinical Development and Operations SWAT team collaborates on initiatives related to clinical operations (incl. supporting trial site readiness and setting up a clinical trial site network, providing information on COVID-19 CTA and EC requirements for specific regions), vaccine safety (incl. AESIs / case definitions, post roll-out vaccine safety surveillance), vaccine science (incl. development of strategic documents on key topics such as standard CT elements, adaptive trial design, Correlate of Protection, alternative/supportive evidence, optimization options) and maternal immunization. Co-Leads: Peter Dull (BMGF), Jakob Cramer (CEPI) |
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Vaccine Safety
Workshops:
Workshop Material: COVID-19 Vaccines Risk Management Planning: Stakeholders Experiences and Perspectives | 28 Apr 2021 Workshop Report
Workshop Report: COVAX Vaccine Safety Working Group: Developer Needs Workshop | 21 Oct 2020 | By Dr Julia Granerod
Documents:
Priority List of COVID-19 Adverse events of special interest: Quarterly update 2 | December 2020 | By Barbara Law
Consensus considerations on the assessment of the risk of disease enhancement with COVID-19 vaccines: Outcome of a Coalition for Epidemic Preparedness Innovations (CEPI)/Brighton Collaboration (BC) scientific working meeting. | March 12-13, 2020
Brighton Collaboration Case Definition: Acute Respiratory Distress Syndrome (AARDS)
Further information on the Brighton Collaboration's work on COVID-19 can be found here.
BRIGHTON COLLABORATION CASE DEFINITION COMPANION GUIDES
Companion guides have been created as part of the CEPI-funded SPEAC project. They contain resources and tools specific to events that have a published Brighton Collaboration (BC) case definition. The resources include risk factors and background rates for the event as well as a summary of key caveats from the case definition to: 1) guide real time investigations needed to meet the case definition as well as to look for diseases that would exclude the event as a case; and 2) guidelines for analysis and presentation of the event as an adverse event of special interest (AESI). The tools include a detailed case report form that guides the abstraction and interpretation of key data from medical records needed to meet case definition criteria as well as two different abbreviated one page formats for summarizing data on the case definition criteria and algorithms to assign the level of certainty.
- Generalized Convulsion: Case Definition Companion Guide | 5 March 2021
- Anaphylaxis: Case Definition Companion Guide | 5 March 2021
- Facial Nerve Palsy: Case Definition Companion Guide | 5 March 2021
- Acute Disseminated Encephalomyelitis (ADEM): Case Definition Companion Guide | 5 March 2021
- Acute Encephalitis: Case Definition Companion Guide | 5 March 2021
- Thrombocytopenia: Case Definition Companion Guide | 5 March 2021
- Aseptic Meningitis: Case Definition Companion Guide | 5 March 2021
- Guillain Barré and Miller Fisher Syndromes: Case Definition Companion Guide | 5 March 2021
- Acute Myelitis: Case Definition Companion Guide | 13 February 2021
New BC case definition companion guides will be posted as they become available. Links will also be added to the Google spreadsheet listing all Brighton Collaboration (BC) publications and related tools (which is sortable and filterable by column, and provides direct clickable links to publication DOIs).
Training
CEPI Sponsored DSMB Training Course - deadline for application: Friday 9 April 2021
The Coalition for Epidemic Preparedness and Innovation (CEPI) through the Safety Platform for Emergency vACcines (SPEAC) project, has funded the development of a training program for potential Data and Safety Monitoring Board (DSMB) participation which will prioritize participants from low and middle-income countries (LMIC).
WHO COVID-19 Safety Surveillance Manual