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U.S. Department of Health and Human Services

About FDA

Execute Cooperative Agreement with World Health Organization (WHO)

Description: The Cooperative Agreement is a collaborative effort between CBER and WHO to advance innovative approaches to vaccine clinical trial designs and to enhance the utilization of a range of pharmacovigilance tools as a means to further vaccine safety. Public Health Outcome: These activities support the public health goal of enhancing access of the global population to safe and effective vaccines and potentially facilitate more rapid introduction of lifesaving vaccines.

Accomplishment: These activities supported the public health goal of enhancing access of the global population to safe and effective vaccines. Project accomplishments of Year 1 include:

  • Development of Global Vaccine Safety Multi-country Collaboration for signal evaluation and hypothesis testing;
  • Case definition for narcolepsy as an adverse event of special interest following influenza vaccines;
  • FDA/CBER training course in pharmacovigilance at Uppsala Monitoring Center;
  • Development of data management tools for Adverse Events Following Immunization (AEFI) reports and reporting; and
  • Support for Global Advisory Committee on Vaccine Safety sub-group on influenza vaccines.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. First quarterly progress report meeting with WHO (Year 1)

12/31/2012

Completed 11/29/2012

B. Second quarterly progress report meeting with WHO (Year 1)

3/31/2013

Completed 2/28/2013

C. Third quarterly progress report meeting with WHO (Year 1)

6/30/2013

Completed 5/31/2013

D. Funding for Year 2 approved by CBER Center Director

9/14/2013

Completed 9/4/2013

E. Fourth quarterly progress report meeting with WHO (Year 1)

9/30/2013

Completed 9/27/2013

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.