Recommendation 4.9: The committee recommends that when final results from VSD analyses or studies are released through publication or through presentation at a meeting, preliminary findings be shared only rarely, but that the dataset from which the final results were obtained be available to other researchers who may verify and extend the results through an audit or broader reanalysis.

Recommendation 4.10: The committee recommends that any preliminary findings based on VSD data that are shared with the public be put into appropriate statistical and scientific context with clear characterization of the uncertainties in the findings, of the strengths and limitations of the data, and of the possibility that new data or new analyses could change interpretations.

Chapter 5:

INDEPENDENT REVIEW OF VACCINE SAFETY DATALINK ACTIVITIES

Recommendation 5.1: The committee recommends that a subcommittee of the National Vaccine Advisory Committee that includes representatives of a wide variety of stakeholders (such as advocacy groups, vaccine manufacturers, FDA, and CDC) review and provide advice to the NIP on the VSD research plan annually. The subcommittee charged with this role could be the existing Subcommittee on Safety and Communications or a subcommittee created specifically for the purpose.

Recommendation 5.2: The committee recommends that the NIP propose to the National Vaccine Program that additional liaison representatives be appointed to ensure that all perspectives are heard by adequately representing advocacy groups and other members of the public at subcommittee meetings addressing the VSD research plan.

Recommendation 5.3: The committee recommends that an independent review committee with minimal and balanced biases and conflicts of interest be created to:

  • Review independent external researchers’ proposals to use VSD data through the data sharing program;

  • Review research proposals from internal researchers and provide oversight of changes in or deviations from research protocols for internal VSD studies; and

  • Provide advice on when and how preliminary findings based on VSD data should be made public.



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