How to Build Trust in Covid-19 Vaccines: Fresh thinking and behavioral research are needed to build trust and complement authoritative and data-oriented communications. A lot has been written on the importance of known, trusted messengers of information including doctors and nurses, community thought leaders like ministers, or heads of important community groups. However, our existing knowledge base is in the context of childhood vaccines. Trusted voices and strategies to support a potential COVID-19 vaccine need to be identified. Discussions with family and friends can help address people’s concerns, yet this is not part of the current strategy to encourage vaccination.25 There is evidence that traditionally trusted sources like the U.S. Centers for Disease Control and Prevention are seen as less reliable in the context of a COVID-19 vaccine than are doctors and nurses.26 Given the importance of community opinions and social norms, vaccine messaging and engagement should address specific communities known for low vaccination compliance.27 We have a window of opportunity to course correct to ensure that we have a vaccine that is not just safe, effective and available but is also trusted. That work should begin immediately.
The placebo paradox: Why a COVID-19 vaccine trial participant might drop out: A third solution to the placebo paradox—and the holy grail of vaccine research—is called a “correlate of protection,” a measurement of a specific immune system marker that vaccine researchers could use to predict immunity requirements for protection from the virus that causes COVID-19, SARS-CoV-2. Last week, vaccine expert Dan Barouch and a team of researchers published their discoveries from a new primate study that suggests future vaccines could be licensed based on immune correlates, rather than clinical efficacy. Testing future Covid-19 vaccines swiftly and without human subjects removes the placebo control arm dilemma entirely and is already done annually with influenza vaccines.
To further these possible solutions, the 21st Century Cures Act was signed into law in 2016, mandating research into new ways of generating “real world evidence” from “sources other than randomized control studies.”
For today’s crisis, ensuring the safe approval of the quantities and variety of vaccines needed to supply the entire world will require the FDA and other regulatory bodies to consider implementing variants of these solutions, with the same open mind that allowed the initial rapid success of the Pfizer and Moderna vaccines. If the FDA finds a way for trial participants to make informed decisions and provides a reasonable endpoint for the studies, those of us who can safely and practically do so will not abandon our posts.
