Electronic health data systems that still can’t fully talk to one another will create challenges flagging side effects of any Covid-19 vaccine once it hits the market.
Surveillance systems to monitor everything from vaccines to cough drops have been in place for decades, and the CDC said it plans to beef up what it does for Covid-19. But finding long-term safety data on a vaccine that will likely be authorized for some segments of the population after a few months—and not years as is typical for a vaccine monitoring—will require changing the culture of patients and health-care providers who aren’t used to reporting side effects, drug safety experts said.
“For this vaccine, ideally what you’d like to have is a big network in which you could find all the people that have adverse events,” David Westfall Bates, who is the medical director of clinical and quality analysis and information systems at Partners HealthCare System Inc., said. Models already exist such as the Vaccine Safety Datalink, a program between the Centers for Disease Control and Prevention and nine health-care organizations to monitor safety and study adverse events, he said. But for a Covid-19 vaccine, “you’d want to like roll it out all over the country.”
“These adverse events can be pretty rare. And they may not occur frequently enough to show up in the population that you’re studying,” Bates said.
The Department of Health and Human Services Office of the National Coordinator for Health Information Technology for years worked on rules to ensure medical systems were able to communicate with one another, making it easier for patients to access their medical records and boosting the market for medical apps. Connecting the databases necessary to track the distribution and possible side effects of a Covid-19 vaccine will pose a significant test of those efforts.
The FDA requires large clinical trials to follow patients for a median of two months after their last shot because that’s when most adverse events happen. Vaccine trials for shingles and other diseases followed patients for years after the last shot, but Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said doing so could delay ending the pandemic, especially when the vaccine already demonstrated safety.
The FDA may issue an emergency use authorization for a Covid-19 vaccine to speed access for frontline health-care workers and other priority recipients.
Tracking Side Effects
Using a patient registry to augment information gleaned from insurance claims and electronic health records will allow drug safety monitors to compare any outcomes of people who were vaccinated with those never received a shot, Nancy A. Dreyer, chief scientific officer and the head of the Center for Advanced Evidence Generation at IQVIA Real World Solutions, said. That will also make it easier to compare different vaccines.
“Yes, this will continue to push our IT infrastructure, but we’ve already started down this path, with many successful examples to learn from,” she said.
The Food and Drug Administration and CDC have managed a vaccines adverse event reporting system (VAERS) since 1990, and the FDA’s Sentinel system has monitored the safety of approved medical products since 2008. For Covid-19 vaccines, the FDA said it plans to use Sentintel’s biologics effectiveness and safety system, or BEST, combined with data from the Centers for Medicare & Medicaid Services and Veterans Administration to monitor the safety and effectiveness of vaccines.
Drug safety programs work well in Massachusetts, which has a statewide repository where doctors can readily import most vaccinations they’ve administered, Bates said. But collecting vaccine data is uneven from state to state and most people don’t report a vaccine-related event because they’re not used to doing it.
Jay C. Butler, CDC’s deputy director for infectious diseases, said the centers are setting up a program called Be Safe allowing patients to report any adverse events directly.
Making the Data Match
CDC leaders plan to beef up monitoring programs for Covid-19, but the government already has the capacity as to conduct this type of post-market surveillance because it does this for all vaccines, Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said at Everbridge’s Covid-19 symposium.
“We continue to evaluate vaccines forever. We’re evaluating vaccines now that were introduced 20 years ago,” she said. “The current vaccine safety systems are strong and robust.”
But a lack of standards for data collection and the inability of health systems to talk to one another will be challenges that will need to be ironed out.
“We’re all aware of all these wonderful things that promise interoperability. And I think, frankly, we’ll eventually deliver interoperability,” said Christopher G. Chute, chief research information officer of Johns Hopkins Medicine and deputy director of the Institute for Clinical and Translational Research. But in the real world of 2020, the different vocabulary, data elements, and data sets that each institution uses when collecting patient information may mean these data aren’t necessarily comparable, he said.
Christoph Lehmann, director of the clinical informatics center at University of Texas Southwestern Medical Center, said relying on existing data systems is misguided.
The problems with hospitals reporting Covid-19 data to federal agencies—which he called an unfunded mandate that required almost a dozen full-time employees—created quality issues because of inconsistencies in different electronic health records and state and local health departments working with outdated technology because of chronic underfunding. That suggests the IT infrastructure isn’t ready, he said.
“At best, it will be a very incomplete, inaccurate picture of what’s happening in real life,” Lehmann said. “The Covid pandemic has challenged our health systems in a matter that it essentially broke it and resulted in really, really bad data.”
A registry that provides an easy way for patients to report side effects directly to the CDC or FDA is a best case scenario, said Catherine Baldridge, owner of Essential Pharmacovigilance LLC. At the same time, she said using combined medical records, claims data, and registries could complicate data collection. There needs to be ways to weed out duplicate incidents.
Improving reporting systems hasn’t been a priority for health-care organizations or electronic health record vendors, Bates said.
“We could use a little more progress around making it easy to send things out from electronic health records,” he said. “Obviously, Covid has changed the way that people look at things. And it’s obvious in terms of Covid how important an infection like this is. But most of the rest of the time this [has] just been placed fairly low on the priority list.”
The FDA acknowledged shortcomings of electronic health records, noting patients often receive health care at different facilities and one record is unlikely to capture a patient’s complete health information.
“Many times these facilities provide healthcare for very specific conditions or diseases and may not capture the primary care that patients receive on a regular basis such as annual physicals, vaccinations and other routine care,” FDA said.
Baldridge, who is the past chair of the Drug Information Association’s Clinical Safety and Pharmacovigilance Community, said educating patients and health-care teams about the importance of reporting any side effects could go a long way.
“That’s not in our culture of drug development,” she said. Most patients don’t know they can report side effects directly to the FDA or the pharmaceutical company. “We’re only as good as the data we have. And that’s always been the case.”