- The CIOMS Guide to Vaccine Safety Communication (Guide) is meant to be a standalone document with a focus on vaccines and tailored toward regulators, especially in Resource Limited Countries (RLC). Yet it can also be seen as essential accompaniment to the recently published CIOMS Guide to Active Vaccines Safety Surveillance (CIOMS, 2017). Moreover, the Guide could be useful to all stakeholders who have expertise or are interested in vaccine safety and have relevance for all medicinal products and applicable worldwide.
- Public consultation is invited from individuals and institutions to submit comments below.
- Comments may be general and/or by sections, referring to the line number of the passage in question. Feedback is limited to one page per section. We kindly request in each instance to include constructive suggestions for correcting or improving the text rather than simply critiquing. In the case of organizations, collating staff comments into one form per organization would be much appreciated.
- Unfortunately we cannot give individual feedback from the consultation and we will normally not attribute specific public consultation comments to specific authors, nor we will publish the comments. We will exercise our editorial prerogative to incorporate comments and suggestions according to our judgment. We will acknowledge significant input in the final report, with a list of names and affiliation or institutions, for those who choose to have their identities be included.
- Please be aware that some regional initiatives on vaccine communication are currently in process at the time of this public consultation (e.g. IMI-ADVANCE, see http://www.advance-vaccines.eu/). Their results will be reflected in the final CIOMS report. Comments during public consultation could provide valuable information about relevant publications and examples in case any major ones are missing in the draft.
- The period of public consultation is open until Friday 22 September 2017. Any submissions received after that date cannot be assured consideration due to timing constraints. The final report is set to be published by late Autumn 2017.
- We are particularly seeking feedback on the most desirable appendices to include for practical ideas on specific areas of vaccine safety communication (see suggested areas in Appendices 1-5). We also request any important missing references and guides for our reading list (Annex 1). We welcome input about what other resources regulators may use. In the EU, Member States (surveyed in July 2015) did not have any specific guidance they could identify (according to survey with responses from 16 out of 28 Member States). They were, however, aware of WHO guidelines.
Many thanks for your comments, corrections, additional suggestions, and general feedback.
Sincerely, Priya Bahri (EMA, Editor), Karin Holm (CIOMS In-house Editor), Lembit Rägo (CIOMS Secretary-General)