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. 2019 Jun 27;19(11):e399–e403. doi: 10.1016/S1473-3099(19)30305-6

Table.

Key vaccine development activities that should occur before and during a disease outbreak

Actions before an outbreak Actions during an outbreak
Sequence, serotype, and share outbreak strain Identify people and agencies, including local investigators, who will be expected to undertake this activity; ensure that MTAs, safe storage and transport, and fair allocation mechanisms for sharing specimens are in place; ensure mechanisms are in place for rapid release of funds to support the research Sequence, serotype, and disseminate results; share outbreak strain with vaccine and animal model development teams
Collect acute and convalescent blood samples and other body fluid specimens Identify and fund investigators, including local investigators collaborating with front-line caregivers, who will collect and process specimens and maintain chain of custody; ensure specimen collection and handling is consistent with expected analytic needs; ensure that protocols, MTAs, and safe storage and transport (if needed) are in place; seek preapproval of protocol from ethics committee; ensure funding, supplies, and personnel are ready to begin when outbreak starts Collect and transport or safely store specimens; if not done in advance with WHO, convene a scientific advisory committee to prioritise how samples should be interrogated and who they should be allocated to
Accelerate development of diagnostic tests that can serve as endpoints for vaccine trials Determine which diagnostic tests will likely be needed to support vaccine development, particularly tests that are different from those needed for outbreak detection and response; identify possible researchers and organisations who can develop these tests, and ensure protocols and agreements are in place, and that they have needed access to funds; collaborate with the specimen collection effort to ensure panels for test validation are rapidly assembled, and a process for allocating them is in place Develop and validate diagnostic tests that will be needed for vaccine development; if relevant, ensure additional specimens are available for post outbreak validation and confirmation
Do epidemiological studies essential for vaccine development Identify and assess current surveillance systems and address key gaps relevant to vaccine development; ensure investigators who will work alongside outbreak response teams to collect data needed for vaccine development, trial design, and planning are trained and prepared; to the greatest extent possible, develop collection and testing protocols with investigators and public health authorities in advance of outbreak, and seek preapproval from the ethics committees; plan coordination between clinical trial teams and outbreak investigators, if a trial or vaccination effort is anticipated (eg, ring vaccination); ensure personnel, supplies, and rapidly available funding are in place Collect and analyse epidemiological data (eg, seroprevalence, incidence, transmission dynamics, and geographical distribution) to support vaccine trial planning
Understand cultures and beliefs Identify behavioral and anthropological science team with relevant linguistic and cultural competencies; develop generic protocols for understanding knowledge, attitudes, beliefs in community, and seek preapproval of ethics committees; develop a just-in-time training package for local community members who will be involved in the work; ensure personnel, supplies, funding, and rapidly available funding are in place Understand community beliefs regarding the disease, its control, and vaccination; provide community education through locally trained and trusted workforce

MTA=material transfer agreement.