Webinar: Vaccine Confidence in the Context of Trials

"As rumours and misinformation around vaccination and vaccine trials have become increasingly challenging, listening to communities and online conversations to detect and mitigate rumours with a risk of disrupting vaccine trials is key. This is particularly important in the context of COVID-19..."

Part of a Vaccine Confidence Project (VCP) webinar series, taking place in July and September 2020, this video provides an overview of the VCP framework for detecting and mitigating rumours around vaccine trials, with guidance on community management of rumours (using the example of the Ebola vaccine trials) and social media monitoring to listen to public sentiments, beliefs, and concerns around vaccination.

Following a welcome and introduction by Heidi Larson, Professor of Anthropology, Risk and Decision Science and Director of the VCP, London School of Hygiene & Tropical Medicine (LSHTM), the webinar begins with a discussion by Emilie Karafillakis, Lead for European Research at the VCP, LSHTM of the "social listening" VCP is doing with social media around a number of vaccine trials in support of the Medical Research Council (MRC)-funded trials vaccine trials network. They have been monitoring social and digital media for around a year now trying to detect any rumours, concerns, or misinformation circulating around vaccine trials. The approach involves trying to catch rumours when they're in their earlier stages and assessing their risk for disruption. Karafillakis shows slides depicting what constitutes a rumour that actually has a potential to disrupt a vaccine trial versus which one doesn't; this framework helps VCP to know which ones to focus on in their communication and engagement strategy.

There is then a 3-step assessment process that involves, first, looking at "rumour prompters" (what is it that might make a rumour start - e.g., publication of new safety data around a vaccine trial). The second step is looking at sustaining an amplifying factor: Is it something that's really just local and shared in one Facebook group but doesn't go further, or is it actually something discussed in mainstream media? VCP then categorises the rumours in a green-yellow-red alert system and takes different actions based on the risk they have assessed. So the process moves from continuous listening to in-depth investigation and more rapid and targeted responses. Karafillakis works through one example concerning COVID-19. This example illustrates that context really does have an influence on how and why certain rumours might take hold in some countries more than others (e.g., a history of failures of medical experimentation in many countries going back from the 1800s has led to an erosion of public trust in the trials system and how trials are implemented in certain countries). Furthermore, the pandemic that we're currently in means we are living in a time of heightened anxiety and panic, which also has the effect of creating an information vacuum that makes it very easy for misinformation and conspiracy theories to take hold, as well as for the recurrence/cycling of older rumours.

The next session features insights from the field. Speakers include:

• Beatriz da Costa Thome, Preventive Medicine Department of the Federal University of São Paulo, Brazil, who speaks about conducting trials in times of emergencies. She describes the process of producing a Nuffield Working Group report (see Related Summaries, below) through the lens of ethics. As Thome explains, this report was largely based on an evidence gathering that involved researchers and survivor groups all over the the world. Something that emerged from this experience was the importance of conducting meaningful community engagement during these trials - indeed, from the very beginning. Of course, during a public health emergency, there are many reasons why it is especially challenging to do so. Thome talks about not only research participants or communities in which the trials will occur but also the local research groups/institutions and local research ethics committees. They can be engaged, for example, in reviewing research protocols if they are sensitised  to really look for how culturally appropriate a research protocol is going to be. Thome gives a practical example from participants in Brazil during the Zika epidemic. Among the lessons learned is around building the public's research literacy. Such lessons should be shared to make sure we go a step further in terms of really bringing communities into research endeavours - not just during the trial time but keeping people engaged and informed.
• Nellie Myburgh, Head Anthropologist, University of Witwatersrand, who talks about the challenges of maternal vaccination trials from the South African perspective. One lesson learned from her experience was that you need to find out who the key players are. South Africa has a strong public health system and a private health system. The public sector is guided by policy that comes from the government, so they vaccinate every pregnant mother with vaccines that are meant to help the mother (e.g., tetanus); in the private sector, it's different, in that different doctors tell their clients different things (and some mothers don't even get a tetanus vaccine). She also found that information relating to vaccines is not available to many, so the mothers in the trial were saying they really didn't know what vaccine they were getting and for what purpose. Even where the mothers were informed that a vaccine was good for them, they didn't understand most of the medical terms that were used. So, we have to find a way to translate high-tech knowledge so that people at the grassroots level understand. Other issues Myburgh discusses are the lack of guidelines for healthcare workers and vaccine stockouts.
• Primus Chi, Social Scientist at KEMRI-Wellcome Trust, Kenya, who explores public perceptions of human challenge studies, something that has generated debate - particularly in the area of confidence and the importance of public understanding. Chi focuses on challenge studies for malaria in Kenya. These studies involve a deliberate infection of a volunteers with the well-characterised strain of an effective agent using a controlled dose/environment, as well as a specific route of administration. The studies seem to be quite helpful in enhancing knowledge about pathogenesis of diseases and expediting the process of vaccine development. However, they raise various social and ethical issues, which Chi briefly examines. He also talks about KEMRI's experience with building community engagement platforms, pointing out the importance of volunteers really understanding what they are engaging in. Notably, the experiences the volunteers get shared back to their communities, which could have serious ramifications on the public perceptions of such studies and even on the products that emanate from them. This is a key thing to keep in mind in the context of COVID-19. Chi suggests that studies should be done in a developing country context where the health systems are strong enough to better manage the side effects that may come from the vaccine or from COVID-19 itself.

An interactive question-and-answer (Q&A) session follows. A few highlights:

• Any there any COVID-19-vaccine-related fake news or social concern studies being done in Brazil or elsewhere in Latin America? Thome indicated that the Ministry of Health in Brazil has been trying to maintain an updated database of fake news online. There are 2 major vaccine trials (both being phase 3 trials) that have already started recruiting participants - healthcare professionals, so the vaccine hesitancy for this group might be different from the general community. But there seems to be enthusiasm for the trials more broadly.
• Which countries are covered by the digital and social listening project? Karafillakis noted that it was a global analysis of multiple countries but with a strong focus on African countries.
• When and if a COVID-19 vaccine becomes available, how are we going to be prepared? The VCP is involved with a new initiative called COVID New Vaccine Information, Communication and Engagement (CONVINCE). (This initiative was discussed in more depth in the earlier webinar.)
• What about vaccine hesitancy beyond trials? Are there community-based tools or frameworks to address vaccine hesitancy? It was pointed out that publics don't really like surprises when it comes to vaccines, so the more we bring them along in this process of COVID-19 trials now, the better.
• Is there a central group related to vaccine confidence that has produced a resource video or short infographics/memes? In short, there are different groups trying to work with the same goal of mitigating fake news and bringing literacy to the larger community. The panellists offered a few examples from their own experience.

Robert Kanwagi, Programme coordinator for EBODAC, World Vision Ireland and Mateus Kambale Sahani, Research Fellow, VCP, LSHTM explore proactive communication and engagement to mitigate the spread of rumours and build resilience and confidence in vaccine trials, with a focus on Ebola trials (in various African countries) but reflecting on implications for other trial processes. They look at some of the reasons rumours surface during clinical trials, studies, or campaigns. The basic issue is uncertainty/anxiety, which is what we are seeing now with COVID-19. Sometimes, people pass on rumours simply for their own benefit (e.g., it helps their social status...some people want to be seen as the originators of information or the originators of a sensational video). The consequence of rumours could be a loss of credibility: People no longer believe in the trials. Rumours also affect participants' recruitment and/or retention, especially in the event of a 2-dose vaccine. If you don't address rumours during the pre- or development phase of the vaccine, these rumours will simply transition into your clinical trials and studies. So, it is critical to map out the different stages when rumours evolve and address them as they emerge.

Turning to the question of how can we proactively engage communities to mitigate the spread of rumours, these panelists delve into the issue of community engagement in terms of citizen participation and feedback, even during the development of the vaccines. Communities should be kept informed about what is being done from the very start and throughout the entire trial. The other thing they learned from the Ebola clinical trial is that you need to standardise the communication to the community. You do not want to have different frontline soldiers or health workers communicating different messages to the community, which could create confusion and even spark rumours. Flipcharts and fact sheets can assist in this regard, but - rather than just throwing these at communities - dialogue is crucial to understanding people's concerns and developing appropriate means to engage them. All frontline workers need to be trained on how to respond to questions that may arise. It can also help to do a social and political analysis to define effective roles for authorities, who can help in navigating the challenges that are likely to arise in ensuring community participation. Furthermore, social science research should inform all communications, and there should be an awareness of existing community structures so the study does not appear to be conflicting with those (at the risk of arousing suspicions). It can be effective to build on these existing structures and strengthen their capacity to lead and foster community partnerships and trust. Other points these panelists made relate to the importance of adhering to ethics in communication and community engagement, issues of child protection, and the need for a crisis communication plan.

Another Q&A session follows with these two presenters. Among the insights to emerge, in light of COVID-19, is that the source of the information is very important. Thus, researchers need to make sure the information is coming from someone the community can trust. This is why it can help to create a group of people who are in the community listening to people and then can give feedback. When publics feel like you're listening and willing to answer their questions, you can slow down or even prevent the spread of rumours because they're not going to other places trying to find information. There is no shortcut here: Give the facts and be transparent and honest, which builds the trust that community requires to participate. Also, it is necessary to assure participants during the entire process of the trial or the study that the providers of the vaccine will do everything possible to ensure their safety, as well as to re-emphasise that it is completely up to the participants to choose whether to participate in the trial or not.

Another question revolved around whether the panelists have experience with successful trainings for journalists to help with community outreach of positive trial messages and whether this an effective strategy. The response was that sometimes there is a sense that journalists are the mouthpiece of the government or whoever; depending on the country, it might be better to think about journalists not in terms of them spreading positive messages but, rather, bringing to light some of the questions they're hearing from the public. This provides researchers with an opportunity to be responsive through journalists to the emerging questions from the public in addition to getting the correct facts out there. As long as we engage with the media continuously - not only when we're living this (COVID-19) crisis - we'll be better off. Whether it's journalists or community members, the idea is not to jump in just in the moment and then be gone when the event or the trial is over; rather, this is a relationship. The more ongoing it is, the more those trusting relations are there with journalists, with community leaders, and/or with religious or political leaders. That will be an asset to any trial.