Barriers and Opportunities to Include Underrepresented Population Groups in Vaccine Trials: Cross-Sectional, Observational, Online Survey Study From the VACCELERATE Research Network

Background: Despite the vast growth of vaccine studies during the SARS-CoV-2 pandemic, clinical trials failed to adequately represent diverse societal groups, resulting in the underrepresentation of specific populations. Understanding the factors hampering participation in vaccine clinical trials is essential to better identify structural, ethical, and communication barriers and to improve inclusive strategies for broader and more equitable participation in future vaccine research. Objective: This study aimed to identify the perceived barriers to participation in vaccine trials among pregnant and lactating women, children aged younger than 18 years, and adults aged older than 65 years, as reported by professionals with expertise in vaccines or vaccine trials. Methods: An online questionnaire was developed to gather personal information, group-specific barriers to vaccine trial participation, and suggestions to overcome these barriers. Data are presented as absolute (n/N) and relative frequencies (%). Results: A total of 115 respondents, the majority (n=73, 63.5%) of whom were working in the scientific community, completed the online survey. Challenges in recruiting children were identified due to "safety or efficacy concerns," "difficulties about ethics and regulatory issues," and "lack of targeted information and communication." Challenges in recruiting pregnant and lactating women were primarily "ethics and regulatory requirements," "safety issues," and "lack of prioritization or interest." "Lack of information and communication channels adapted to the specific target group," along with "lack of prioritization," were the main challenges in recruiting older participants. Provision of health-related incentives, including but not limited to access to new treatments and receiving expert medical care, seems to be the top-rated motivation to participate in vaccine clinical trials. Conclusions: The main challenges in recruiting pregnant and lactating women and children in vaccine trials involve safety and efficacy concerns, as well as lengthy ethical and regulatory processes. For older adults, key issues include poor communication channels tailored to their needs, limited information, lack of prioritization, funding, infrastructure, and industry interest. Across all underrepresented groups, low awareness of and poor communication about research opportunities were major barriers. Additionally, mobility issues affected older adults, while lack of motivation and incentives affected children, and low health literacy and provider uncertainty impacted pregnant and lactating women. Improving communication infrastructure and enhancing communication strategies with clear, tailored messages to build trust and motivate participation are essential to improve inclusion in vaccine research.