Table 3.

Preparedness data needed for informed decision making in the public health response to a potential pandemic threat.

• Public health communication plans should be developed in anticipation of future influenza pandemics. Content should include disease epidemiology, regulatory processes for licensure, the rationale for age-and risk-based vaccine recommendations, and how vaccine safety and effectiveness will be monitored. Information should also be effectively transferred from national and regional levels to local and community levels and ultimately to the provider and patient levels.

• Large linked database systems should be built to conduct near real-time active vaccine safety and effectiveness monitoring during a global influenza pandemic vaccination campaign.

• Vaccine registries should be established, either within monitoring systems or at the national, regional, or state/provincial levels. There would optimally be bidirectional communication capability between registries and the large linked database systems to enhance capture of vaccine exposure for safety and effectiveness monitoring.

• Methods, outcomes, and risk and control intervals for adverse events should be standardized and surveillance systems should incorporate procedures for rapid chart access and data sharing to evaluate potential safety signals.

• Clinical trials and licensure of adjuvanted pre-pandemic (i.e., pandemic candidate) vaccines should be encouraged in advance of a pandemic. These should give consideration to the inclusion of children, the elderly, those with chronic illnesses, pregnant women, and include sufficient racial and ethnic minorities to be representative of the general population. It was however recognized that the ethics including vulnerable groups in such trials in the absence of a pandemic would require careful consideration.

• Modeling should be used to evaluate the benefit-risk balance when limited data are available.

• The roles, responsibilities, and authority of international, European, national, state/provincial, and local public officials should be clarified in advance of a pandemic influenza response and continuously reinforced and communicated to stakeholders and the public during the actual pandemic.

• National and when relevant international committees to investigate and promptly review vaccine adverse events of importance should be constituted during a pandemi influenza campaign.

• Compensation policies should be developed at the national level in advance of a future pandemic for individuals or parents who believe they or their children have suffered an injury from receipt of a recommended pandemic influenza vaccine. The process for developing policies should be transparent and preferably would include consideration of wide stakeholder input (public, healthcare providers, public health officials, etc.).