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)


        

CLINICAL OPERATIONS

Clinical Trial Sites and Networks

COVAX and BMGF have separately provided bridge funding to experienced clinical trial sites around the world in preparation for an unprecedented number of concurrent Phase III clinical trials with new COVID-19 specific infrastructure, physical capacity, and staffing requirements. These sites were selected in partnership with product development partners, who are working to ensure that these sites are ready for Phase III COVID-19 vaccine trials. Site readiness will be confirmed by independent consultants using harmonized criteria. This dashboard provides a high level overview of study sites that have received supportive COVAX or BMGF funding to improve capacity  to conduct phase 3 efficacy studies for Covid-19 vaccines in coming months.  This dashboard will be updated regularly:


Dashboard of COVAX-Supported Sites Ready for Clinical Trials

Please find below a list of other site networks which may be valuable contacts for COVID-19 trials. It should be noted, however, that neither COVAX nor CEPI can accept responsibility for the quality of the investigational sites and this is not to be understood as a recommendation of the networks or individual sites within the networks.

Operational Preparedness Database – COVID-19-specific information on Regulatory and Ethics requirements as well as other operational details by country

 

Trainings

R&D Good Participatory Practice for COVID-19 clinical trials: a toolbox  |  Coronavirus disease (COVID-19) training: Online training

 

Vaccine Development Landscape

WHO COVID-19 vaccine landscape  |  LSHTM Vaccine landscape   |  UNICEF COVID-19 Vaccine Market Dashboard  |   COVID-NMA  | View Hub

 

Epidemiology and Modelling

SeroTracker  |  IHME COVID predictive model   |  Northeastern  |  Los Alamos National Laboratory  |  Youyang Gu  |  USC EEB  |  IDM

NEWCheck out the report titled: An efficient, objective index for predictive disease incidence ranking of COVID-19 vaccine trial sites

 

Regulatory and Ethics | Selected strategic and regulatory guidance documents on Covid-19 Clinical Trials

Africa:   AVAREF   |   WHO Africa

Europe: European Medicines Agency (EMA) | EMA safety monitoring plan and guidance on risk management planning for COVID-19 vaccines

USA: Food and Drug Administration (FDA)  |   NIH- NIAID - ClinRegs   |   ACRO

WHO:  COVID-19 Vaccine PQ  |  Coronavirus disease (COVID-2019) R&D   |   Guidance for managing ethical issues

  |   Interim recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine  |   Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process

 

CROs and Sponsors

CEPI launched a call for Expression of Interest in April 2020 which aimed to identify organisations with capability and interest to act as sponsors or Contract Research Organisations (CROs) for clinical trials involving one or more COVID-19 vaccine candidates. A total of 84 organisations from 26 countries applied. CEPI has performed an in-depth evaluation of the received Expressions of Interest and has provided a summary to its COVID-19 developers. With advanced stage trials planned to start imminently, developers will have a repository of organisations from whom to seek assistance.

 

 

 

 

 

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