After nearly one year of suffering, isolation, and economic downturn on an unprecedented international scale, the expedited development and authorization of COVID-19 vaccines has shown us the light at the tunnel’s end. Having an end in sight is not the same as getting there, however: inoculating the majority of American citizens in a matter of months would be complicated under the best of circumstances. Beyond logistical considerations, continued work is needed to ensure that Americans can have confidence in the safety of these vaccines.
The evidence bar for safety is high and cannot be compromised—especially for diverse populations and settings underrepresented in clinical trials. According to Kaiser Family Foundation, people are most worried about possible side effects, and they lack trust in the government to ensure vaccine safety and effectiveness. A recent Gallup poll reports that about one-third of Americans are not yet willing to receive a vaccine.
The only way to address the public’s skepticism is to assess data on the safety and effectiveness of vaccines in near real time, with technology built for the purpose of producing real-world evidence (RWE). While RWE has long been used for post-marketing safety studies, the pandemic has created new urgency for unlocking what our everyday interactions with the health care system tell us about what health treatments work best for whom, when.
U.S. Food and Drug Administration (FDA) Principal Deputy Commissioner Amy Abernethy M.D., Ph.D., has said that real-world data (RWD) drawn from health records, patients themselves, or even social media could have a more permanent place in drug evaluations, diagnostic tests, and basic clinical research. Importantly, these data reflect disparities based on race, geography, and co-morbidities that often are not captured in clinical trials.
Advancements in technology and scientific methodology enable us to assess these data from disparate sources with transparent, replicable studies. As we move forward with the distribution of vaccines, we can rely on these studies to help boost public confidence in vaccination, and to continue to advance understanding on safety and effectiveness amongst regulators and manufacturers.
Since April 2020, the FDA has been incorporating RWE into its analysis of critical COVID-19 treatment questions. Similarly, groups like the COVID-19 Evidence Accelerator, led by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, have been leading the charge to bring together stakeholders to build understanding of where and how RWE can play a role in fighting the pandemic.
While RWE has been an important tool to support understanding of potential treatments for COVID-19, it will play an even more prominent role in studying vaccine safety across subpopulations. For example, as vaccines are administered to residents of long term care facilities under the FDA’s recent emergency use authorizations, Medicare will begin capturing data on who receives the vaccine and any potential adverse reactions. And as the U.S. government prepares to deploy the vaccine to an even broader population, this will provide a critical source of evidence on the vaccine’s safety in older patients.
Manufacturers are moving quickly to put the right methods, tools, and data in place to enable rapid and improved deployment of RWE for vaccines across populations, but the stakes are high, and it’s crucial that they get this right. Fortunately, advances in technology and data capture can enable them to approach this in novel ways that will provide a roadmap for the future.
The rise of RWE analytics platforms enables manufacturers to conduct research using consistent methodology that can be applied across multiple data sets, and enables regulators to access data, test assumptions, and replicate analyses in a transparent way. RWE analytics also empower manufacturers to proactively prepare and quickly respond to any questions or requests from regulators, as Moderna has stated in its safety planning documents submitted to the FDA. New types of data collection and aggregation have helped advance the use of fit-for-purpose data, continuously updated and linked across care settings. Combining data about real-time patient activity with historical records, as an example, gives us a more complete picture of why a patient may have a given reaction to taking a vaccine. This context is critical to understanding whether the vaccine is safe and effective.
Americans are understandably skeptical of vaccines developed and authorized at a pace never before seen in world history. The effective deployment of RWE technology to assess vaccine safety and effectiveness in real time is the only way to build the public confidence we need to end the pandemic.
First published in Fierce Healthcare.