Table 3.
Consensus recommendations to further improve safety monitoring of immunization in pregnancy programs.
| There is a need for standardized case definitions for an exhaustive set of events. Until these become available, interim definitions should be made available and shared for widest possible use |
| The phrase “key terms” could be used rather than “adverse events” or “events of special interest” given their respective regulatory implications |
| Brighton Collaboration provides an open global platform and mechanisms to lead efforts of definition standardization given their previous work on standardizing case definitions at an international level and their expertise on consensus building |
| An overall evaluation framework should be developed: |
| a. A public consultation should be implemented for review and feedback on the outputs of the meeting |
| b. Interim case definitions should be evaluated at least regarding usefulness, applicability, and reduction of inter-rater variability |
| c. Implementation in simple observational studies (e.g., incidence rate studies) should be pursued and to allow for assessment of applicability and positive predictive values of the definitions and usefulness of terminologies, guidance and tools |
| d. Case definitions could be incorporated into NIH toxicity tables and tested in clinical trials |
| Tools should be developed to facilitate implementation at various levels and may include: |
| a. A data collection tool, such as a case report form/data collection list |
| b. A glossary of enabling terms |
| c. Ontologies of the terms, keeping multilingual data collection in mind |
| d. Disease code mapping for key events should be performed to support case identification |
| There is a need for guidance(s) for harmonized collection, analysis, and presentation of data in prospective and retrospective data ascertainment |
| Guidelines should be shared with various stakeholder groups for review and comment |
| a. This should be done as part of focused stakeholder consultations |
| b. The Council for International Organizations of Medical Sciences (CIOMS) is considering the establishment of a dedicated working group on immunization in pregnancy which may review and potentially recommend the use of standardized case definitions, guidelines, and tools. The existing CIOMS vaccine pharmacovigilance working group may be able to include the topic with review of the Brighton Collaboration case definitions in their next work plan starting 2017 |
| Population-based health care data sources should be identified and incidence rates of key outcomes should be determined (even if outcome definitions differ from those developed by this group) with a particular focus on LMIC while using advanced databases as benchmarks |
| The utility of identified databases in LMIC for observational studies including incidence rate, signal substantiation, and hypothesis testing studies should be assessed |
| Ideally, background rates of key events should be established that are country-specific or site-specific while using common definitions. In practice, this is limited by lack of resources and capacity constraints |
| Optimal models for conducting post-licensure association studies in LMIC should be assessed including comparison of data collection methods, approaches to meta-analysis and pooling, and performance evaluation of comparative analytic methods to inform interpretation of results from real concerns |
| Dissemination strategies should be considered |
| a. The meeting report should be circulated to all participants and for dissemination to their respective institutions |
| b. Participants should raise awareness of this and subsequent efforts within their institutions and professional networks |
| c. The two Taskforces should finalize work and publish concepts |
| d. Brighton Collaboration should make the terms, disease concepts, interim case definitions, guidance, and tools via a dedicated resource platform at its website for immediate use by interested parties |
| e. Funders should be informed about this ongoing process so that they can inform their investigators about the process and availability of interim case definitions |
| The Global Advisory Committee on Vaccine Safety (GACVS) is WHO’s principal advisory body on vaccine safety issues. The committee acknowledged the development of global standards for vaccine safety monitoring by the current initiative. Their further endorsement will be critical for acceptance and sustainability of any recommended guidelines and standards |