Monitoring COVID-19 vaccine safety

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.

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.

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.

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.

For a lot of epidemiological and health economic research, that time lag is not a major problem. But for vaccine surveillance, we need that data much sooner.

Another difficulty comes from people getting vaccinated without filing an insurance claim. For example, the millions of people who have gotten their shots at mass vaccination sites.

In terms of public health, mass vaccination, regardless of insurance status, is a great thing. But the absence of those insurance claims makes it harder to match vaccinated individuals with any adverse events they report — at least for the purposes of large-scale safety studies.

Much of our analysis depends on having access to the claims data that are generated after a health care encounter.

I’ll start with the data lag. Reducing this lag is a large part of the Optum initiative with the FDA. We’ve been able to set up a data feed that is not dependent on the adjudication process, shortening that lag significantly.

For the "missing claim" problem, state registries should capture anyone who got a shot at those public vaccination sites, so we are working with the states to access that information and further improve the accuracy of any inferences drawn from our analysis.

Our host, Dr. Mark McClellan from the Duke-Margolis Center for Health Policy, called this surveillance capability “a foundation that has many applications going forward,” including the continued analysis of our nation’s response to COVID-19 and any future public health emergencies.

We take pride in our ability to contribute to these efforts, and we stand ready to continue to play our part to help ensure the safety and well-being of all populations across the country.