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The Challenges of Vaccine Trial Participation among Underserved and Hard-to-Reach Communities: An Internal Expert Consultation of the VACCELERATE Consortium

Poulimeneas D, Koniordou M, Kousi D, Merakou C, Kopsidas I, Tsopela GC, Argyropoulos  CD , Themistocleous SC, Shiamakkides G, Constantinou M, Alexandrou A, Noula E, Nearchou A, Salmanton-García J, Stewart FA, Heringer S, Albus K, Álvarez-Barco E, Macken A, Di Marzo R, Luis C, Valle-Simón P, Askling HH, Hellemans M, Spivak O, Davis RJ, Azzini AM, Barta I, Souˇcková L, Jancoriene L, Akova M, Mallon PWG, OlesenOF, Frias-Iniesta J, van Damme P, Tóth K, Cohen-Kandli M, Cox RJ, Husa P, Nauclér P, Marques L, Ochando J, Tacconelli E, Zeitlinger M, Cornely OA, Pana ZD and Zaoutis TE.

Underserved and hard-to-reach population groups are under-represented in vaccine trials. Thus, we aimed to identify the challenges of vaccine trial participation of these groups in member countries of the VACCELERATE network. Seventeen National Coordinators (NC), each representing their respective country (15 European countries, Israel, and Turkey), completed an online survey. From 15 eligible groups, those that were more frequently declared underserved/hard-to-reach in vaccine research were ethnic minorities (76.5%), persons experiencing homelessness (70.6%), illegal workers and refugees (64.7%, each). When prioritization for education on vaccine trials was considered, ethnic groups, migrants, and immigrants (5/17, 29.4%) were the groups most frequently identified by the NC as top targets. The most prominent barriers in vaccine trial participation affecting all groups were low levels of health literacy, reluctance to participate in trials due to engagement level, and low levels of trust in vaccines/vaccinations. This study highlighted population groups considered underserved/hard-to-reach in countries contained within the European region, and the respective barriers these groups face when participating in clinical studies. Our findings aid with the design of tailored interventions (within—and across—countries of the European region) and with the development of strategies to overcome major barriers in phase 2 and phase 3 vaccine trial participation. 

Keywords: barriers; COVID-19; Europe; pandemic preparedness; SARS-CoV-2; vaccinations; vaccine education; vaccine trials

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