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U.S. Department of Health and Human Services

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Cytomegalovirus Vaccine Workshop

Description: The purpose of the workshop is to exchange information with industry on the regulatory challenges to developing and licensing a Cytomegalocirus (CMV) vaccine.

Public Health Outcome: The workshop will encourage the identification of issues and the exchange of ideas that relate to the development of a safe and effective vaccine for the significant health problem.

Accomplishment: On January 10 and January 11, 2012, CBER with other agency partners, including NIH, CDC and the National Vaccine Program Office, co-sponsored a workshop focused on the development of cytomegalovirus vaccines. Meeting participants from academia, professional organizations, patient advocacy groups, and the U.S. government reached general consensus of the importance of CMV as a pathogen and the significant potential public health value of a CMV vaccine. Additionally, meeting participants identified clinically relevant endpoints for Phase 3 vaccine trials to address congenital, stem cell transplant, and solid organ transplant CMV indications and developed a framework for a case definition of congenital CMV. Finally, stakeholders identified priorities for further vaccine-related research on CMV, including the development improved immunological assays and epidemiological data.

Briefing Status: COMPLETED

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. Form workshop planning committee and appoint chairperson 3/31/2011
Completed 3/31/2011
B. Complete workshop planning 12/31/2011
Completed 12/31/2011
C. Publish Federal Register Notice 12/16/2011
Completed 12/16/2011
D. Conduct workshop 1/10-11/2012
Completed 1/11/2012
E. Complete workshop report 4/30/2012
Completed 4/27/2012

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.


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.