In October 2006, the CHMP adopted the Guideline on clinical evaluation of new vaccines, which came into effect on 01 February 2007. The EMA defines the scope as follows: " The guideline covers the design of clinical development programs for new vaccines that are intended to provide pre- and postexposure prophylaxis against infectious diseases. Some of the guidance provided is also relevant to the further development of licensed vaccines (i.e. generation of clinical data to support changes to the prescribing information in the post-authorisation period)."
Independent of the fact, that a lot of the content of the 2007 document is still relevant to the development of vaccines today, the scientific process was going on in the last 10 years and a revision is proposed to address issues that have come to light since it came into operation. In this time several new vaccines were developed for pathogens and diseases for which no vaccine was previously available, and existing vaccines were displaced by new product with a higher effectivity than the existing products. In the ongoing programmes on clinical development, a lot of data and experiences were collected - e.g. on vaccination during pregnancy - with the main or sole intent of providing a benefit to the fetus a topic which was not adequately represented in the current guideline.
The new document will include revision, expansion or addition to the following issues:
The public consultation on the new concept paper ended on 30 September 2017. The further timetable proposes to draft the new guideline text during 2017 with the aim of releasing it for a 6 months consultation by 1Q 2018 and finalisation during 4Q 2018. Find more details directly in the "Concept paper on revision of the Guideline on clinical development of vaccines".