EMA publishes Concept Paper on Revision of the Guideline on Clinical Development of Vaccines

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:

• revised guidance on comparative immunogenicity studies, including considerations for interpretation of the results of trials intended to demonstrate non-inferiority or superiority of  immune responses;
• situations in which age de-escalation studies are not necessary; 
• use of different vaccines for priming and boosting;
• issues to consider when attempting to bridge efficacy between vaccines;
• vaccination of pregnant women to protect them and/or their infants;
• selection of appropriate control groups for vaccine efficacy studies in different circumstances;
• comparison of new and licensed vaccines containing antigens from different numbers of types or subtypes of the same organism;
• methods for derivation of immune correlates of protection (ICPs) or threshold values for  interpreting immune response data by various means;
• prediction of vaccine efficacy when there is no ICP and vaccine efficacy studies are not feasible;
• vaccines with modest efficacy and/or that provide a short duration of protection;
• extrapolation of data obtained in geographically/genetically diverse populations to the EU population;
•  consideration of size of the pre-licensure safety database by type of vaccine and its novelty;
• consideration of the safety database by population subgroup;
• special safety considerations by vaccine construct;
• circumstances of limited pre-licensure safety data;
• approaches to vaccine effectiveness, including when there is and is not a prior estimate of vaccine efficacy.

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".