Monitoring COVID-19 vaccine safety

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During the Duke-Margolis Thirteenth Annual Sentinel Initiative Public Workshop, Dr. John Seeger of Optum took part in the discussion involving collaborators on the Food and Drug Administration’s (FDA) Biologics Effectiveness and Safety (BEST) program. I caught up with him about his experience.

Let’s begin with the basics. What is the BEST program, and how does it relate to the Sentinel Initiative?

I’ll start with the Sentinel Initiative. It’s the electronic system that helps the FDA monitor the safety of regulated products that fall under the agency’s purview, like drugs, biologics, medical devices, and vaccines.

The BEST system is part of the broader Sentinel Initiative, and its aim is to help the Center for Biologics Evaluation and Research (CBER) at the FDA conduct surveillance and epidemiologic studies by creating access to new methods, tools and sources of data.

The BEST Initiative pulls real-world data from multiple electronic health care sources, including claims, electronic health records (EHRs) and linked claims-EHR data, ultimately providing evidence for regulatory decisions.

When did Optum begin to work with BEST, and what major initiatives have you been working on?

Optum began working with the FDA in the fall of 2020, partnering to provide access to health care data and scientific expertise. We support the development of research studies, from defining objectives and identifying data sources to interpreting and communicating results.

Our team contributes to protocols related to the prevention and treatment of COVID-19, including vaccine safety monitoring and surveillance. We also leverage our robust claims and EHR databases to provide evidence for regulatory decisions and to execute epidemiologic protocols.

What were you asked to share at the Sentinel Initiative Public Workshop?

Because of our important work with the FDA, I was invited to lead part of the dialogue on COVID-19 Vaccine Surveillance within the BEST initiative, followed by a group discussion around the topic.

I shared information about how our team is reducing the research data lag through Rapid-Cycle Analysis — or RCA.

RCA empowers us to run quick, almost real-time analysis of vaccine outcomes by detecting adverse events and weighing them against the comparison group — a group of similar people who have not received the vaccine.

When I spoke at the Duke-Margolis event in early November, we had just completed an analysis that included data from vaccinations that were administered in mid-October.

That’s close to the theoretical minimum when it comes to time lags, because there’s usually a delay between when the shot goes into the arm and when the provider actually submits the claim.

This way, we're able to quickly form conclusions and inform the public on our latest vaccine safety analyses, which has become increasingly important as the virus causing COVID-19 continues to evolve.

Our work helps inform many of the risk-benefit questions that the FDA must address. For example, we evaluated the risk of rare heart-related side effects in children ages 5–11 for a COVID-19 vaccine.

The FDA advisory committee referenced that real-world evidence when it recommended the vaccine’s use in that population — a step that goes a long way toward a return to normalcy by helping to keep schools open and families safer.

Why is public surveillance so difficult, even for something as high profile as COVID-19 vaccines?

Our health system isn’t set up to share data easily across organizations or disciplines. Optum helps fill that gap by using our extensive databases to analyze health outcomes in different patient populations.

Unfortunately, there is usually a three to six-month lag between the time the patient sees a provider and when the associated claim is available to researchers.