The decision to temporarily pause administration of Johnson & Johnson’s COVID-19 vaccine while regulators investigated a rare adverse effect has focused attention on the federal process for evaluating postmarket vaccine safety. Right now, different federal agencies maintain overlapping jurisdictions, obligations, and techniques to monitor vaccine safety. The system is rigorous and has many virtues, but to improve its functions, this mission should be consolidated under a single agency.
One of the primary tools for collecting information about potential vaccine-related adverse events is the Vaccine Adverse Event Reporting System (VAERS), a program primarily operated by the US Centers for Disease Control and Prevention (CDC), although the US Food and Drug Administration (FDA) provides funding and advises on its operation. To uncover postmarket safety events that occur after administration of vaccines, the system relies largely on spontaneous reports typically entered by clinicians. The data, which the CDC stores electronically in the Vaccine Safety Datalink, provide an important tripwire to help identify early safety signals that require deeper investigation.
However, like the FDA’s MedWatch program, VAERS is mostly a passive system that relies on self-reporting by physicians. The program was created as part of the 1986 National Childhood Vaccine Injury Act, which required clinicians to report on potential vaccine-associated adverse events. Because not all clinicians report to VAERS or are likely to associate a potential safety issue with a vaccine, the system tends to capture only certain events.1 To complement VAERS, the CDC’s Vaccine Safety Datalink also incorporates information from a more active surveillance system, using data from a set of health maintenance organizations; however, in an era of rich electronic data sets, the project is limited in its scope and the types of patients who are included.
Recognizing the limitations of passive reporting for postmarket pharmacovigilance,2 the FDA has led a substantial effort in recent years to create a postmarket safety surveillance system that relies on near–real-time reporting using information gathered from electronic health records (EHRs).3 These records can allow more timely analysis and are now being used by the FDA as part of its postmarket surveillance of the COVID-19 vaccines, including its evaluation of Johnson & Johnson’s product.
As part of this broader undertaking, the FDA’s Center for Biologics Evaluation and Research uses its Biologics Effectiveness and Safety (BEST) program, which incorporates the use of real-world evidence with the agency’s other surveillance tools. The BEST system comprises data derived from medical claims, EHRs, and linked claims-EHR databases. This FDA program also collaborates with the Centers for Medicare & Medicaid Services to leverage Medicare claims data for assessments of the safety of vaccines for people aged 65 years or older. Because real-world data are often captured in unstructured documents, sometimes as part of free text included in the EHR, the FDA has also led the development of tools for standardizing information and assembling it into formats that enable easier analysis.4 The agency’s investment in these modern tools was accelerated as part of a formal budget request in 2018 that was funded by Congress.
These new real-time reporting programs augment the FDA’s Sentinel Initiative, another electronic postmarket surveillance program that uses claims data submitted to payers. Using these claims data, the FDA can associate the administration of drugs and vaccines with medical claims to identify adverse events that may have been related to the use of a medical product.5 The FDA’s initiatives for real-time surveillance, including the BEST program, are coupled to the Sentinel system. Along with the passive reporting provided by systems like VAERS, this integrated data platform is now the backbone of a modern, robust organization for monitoring the postmarket safety of vaccines.
But there is overlapping jurisdiction for evaluating postmarket safety information related to vaccines, with the CDC taking primary charge for passive reporting through VAERS and the FDA directed in recent years to create a system for active, near–real-time surveillance. This raises the question of whether these separate tasks of maintaining both backward-looking and forward-looking surveillance systems should instead be consolidated into a single integrated effort.
The FDA’s work on postmarket pharmacovigilance related to drugs provides a model for joining these capabilities. The agency operates a passive reporting program for drugs, the FDA Adverse Event Reporting System (FAERS), that is similar to VAERS. Coupling the information derived from FAERS with data from the Sentinel system provides a critical tool for safety researchers.6 The drug program shows how the utility of passive reporting can be expanded by embedding it with an active reporting system like the one the FDA has developed, so that when signals are first identified, they can be quickly assessed through focused investigations using real-world data. The proximity of FAERS to the Sentinel system (both are housed at the FDA) enables more seamless integration.
To build a unified vaccine surveillance system, moving the VAERS program to the FDA should be considered along with structuring the postmarket vaccine safety program similarly to the way drug safety surveillance is organized, joining passive and active monitoring into an integrated platform. Ultimately, the goal should be a tool that can become a national utility to inform on a host of important postmarket questions related to vaccines. The dual jurisdiction maintained for vaccine safety surveillance (in part, a product of the 1986 law that created VAERS) was adequate in a world when most of the monitoring was done through passive reports. As the FDA develops better systems for active monitoring and near–real-time surveillance using EHRs, the passive tools will maintain their maximum utility only as part of a combined system.7,8
In the case of Johnson & Johnson’s vaccine, both the FDA and the CDC conducted separate investigations, even as they collaborated on key elements of this work. Each agency has a distinct mandate—the CDC through its administration of VAERs and its recent commitment to bring vaccine safety questions before it to the agency’s Advisory Committee on Immunization Practices and the FDA through its platform for leveraging EHRs, its substantial resources and authority for collecting detailed information from clinicians and sponsors to conduct focused evaluations, and its responsibility for the postmarket regulation of product-specific safety issues.
The dual jurisdiction and separate responsibilities have created some confusion and complexity in the conduct of this critical investigation. Rather than continue to maintain these functions across 2 agencies, with the challenges that may come with that potential fragmentation, it is time to consider the adoption of a single integrated vaccine safety program housed inside the FDA.
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Gottlieb S. JAMA Health Forum.
Corresponding Author: Scott Gottlieb, MD, American Enterprise Institute, 1789 Massachusetts Ave NW, Washington, DC 20036 (firstname.lastname@example.org).
Conflict of Interest Disclosures: Dr Gottlieb reported receiving personal fees from Pfizer, Illumina, Tempus, National Resilience, Mount Sinai, New Enterprise Associates, and American Enterprise Associates. No other disclosures were reported.
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Gottlieb S. Evaluating Postmarket Vaccine Safety—Time to Consolidate This Mission at a Single Agency. JAMA Health Forum. 2021;2(4):e211236. doi:10.1001/jamahealthforum.2021.1236