1. Criteria to Demonstrate Need for New Vaccine Formulations or Delivery Methods: Results from a Delphi Survey Lauri Smithee 1, Hélène Carabin 1, Linda Cowan 1, Jennifer D Peck 1, Mushfiq Tarafder 1,2, Ana Maria Henao-Restrepo 3 1 Department of Biostatistics and Epidemiology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 2 Department of Family Medicine and Community Health, The Commonwealth Medical College, Scranton, PA 3 Initiative for Vaccine Research, RPD, World Health Organization, Geneva, Switzerland Background ● Approximately 2.1 million deaths occur globally each year due to vaccine preventable diseases & 1.4 million occurred in children < 5 years of age Objective Develop standardized criteria to demonstrate the need for a new vaccine formulation or a new method of vaccine delivery do not exist. Methods ● Delphi survey: Iterative process of questionnaire administration, response, & feedback. ● Global experts identified via WHO databases representing 7 areas of concentration. ● Survey conducted using Lickert scale and SurveyMonkey ©. ● Acceptability Score Unimportant - median < or = 5 Equivocal - median 6 or 7 Acceptable - median = or > 8 ● Consensus Score: as defined by Baumann Funding: Initiative for Vaccine Research, World Health Organization. Results ● 1152 e-mail invitations were sent; 789 (68.5%) were delivered. ● 179/789 (22.7%) respondents represented 53 countries & 6 WHO Regions. ● 38 criteria were acceptable and achieved “good” or “some” consensus. ● 1 criteria was added by respondents. Conclusion ● This is the first set of essential criteria developed to be utilized in future endeavours to demonstrate the need for new vaccine formulations or delivery systems. Results ● Responses in scoring criteria exhibited “ceiling effects”, clustered in the high end of the Likert scale. 4 criteria ranked highest: - vaccine coverage needed to prevent transmission - efficacy of the current vaccine - frequency of AEFIs - the impact of a proposed new vaccine or methodology on coverage and effectiveness ● 9 criteria scored significantly higher among experts from developing countries vs developed countries (Tbl 1). ● Any decrease in the effectiveness of a proposed new vaccine was unacceptable, regardless of cost. ● Over half of respondents supported increased costs of 10% to 25% to increase coverage by 10% with a new vaccine delivery technology. Table 1. Criteria that varied significantly in developing vs developed countries. Delphi CriteriaDeveloping (n=46) Developed (n=133) p-value MinMedianMaxMinMedianMax Frequency of outbreaks due to the disease 391058 0.003 Severity and frequency of disease outcomes 191038 0.02 Direct costs to treat disease outcomes 291038 0.007 Average age at infection in geographic areas affected by the disease 291028 0.003 Coverage of the current vaccine(s)191038 0.02 Description of the new vaccine formulations or new routes of vaccine administration and the efficacy of each 310 59 0.015 Agreement on an antibody level (titre) that is predictive of protection 391028 0.022 Complication of use of the new vaccine/vaccine delivery method as compared to the current 110 59 0.004 Vaccination method that would not require health care professionals for administration. 110 19 0.015 Discussion ● The overall response proportion was 23%, but all areas of concentration were equivalently represented. ● Overall, the experts valued increased efficacy, coverage, and effectiveness to a reduction in the vaccine cost. Alternative vaccine more expensive. Alternative vaccine less expensive. Alternative vaccine more effective. Alternative vaccine less effective. III IIIIV A b c d e f g h a Figure 1. Cost-effectiveness Plane.