Multiple federal agencies have longstanding systems set up to receive and investigate reports of adverse events from vaccination, and more are being put into place because of COVID-19.
Given the unprecedented scale of COVID-19 vaccination efforts, Dr. Albert Ko, professor of epidemiology and medicine and department chair at the Yale School of Public Health, is concerned about getting reports investigated quickly, in part because stories can spiral on social media.
For example, he said a nursing home resident could get immunized “and 24 to 48 hours afterward, they have a stroke, for completely separate reasons.”
Similarly, state Rep. William Petit, R-Plainville, noted that association doesn’t imply causality, but that’s lost on many people.
“You may have some coincidental occurrences, and it’s going to be important to tease them out before they develop a life of their own, and run in the wrong direction and send people the wrong message,” said Petit, a physician. He said rapidity in investigating “will be critical so people can feel reassured and make the best decision they can for themselves and their family.”
Ko and Petit are members of the state’s COVID-19 Vaccine Advisory Group Science Subcommittee, which met virtually Monday night.
The main agenda item was an overview from Kathy Kudish, immunization program manager for the state Department of Public Health, on COVID-19 vaccine safety surveillance and reporting systems. Largely using content from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, she explained the various systems.
Anyone can submit a report to the Vaccine Adverse Event Reporting System, which is co-managed by the CDC and the Food and Drug Administration. Kudish said VAERS collects reports of adverse events from health care professionals, vaccine manufacturers and the public after vaccination.
“VAERS is not meant to determine if an adverse event is caused by a vaccine, but rather to capture a wide net of adverse events reported, in particular the unexpected, those that appear to happen more often than expected, or that have unusual patterns,” Kudish explained. She said since VAERS reports don’t detect causal associations, public misinterpretation of the information is a struggle.
Kudish said these reports are followed up on for specific studies and, for reports classified as serious, scientists will try to obtain medical records and documentation.
According to an October presentation from Tom Shimabukuro, of the Vaccine Safety Team on the CDC COVID-19 Vaccine Task Force, processing times from COVID-19 vaccine reports — “i.e. reviewed, coded, incorporated into VAERS database” — will be one day for death reports and three days for reports classified as serious.
Veterans Affairs, the Department of Defense and the CDC’s National Healthcare Safety Network, which provides long-term care facilities a system to track infections and prevention measures, feed their own reporting into VAERS.
There’s also V-safe, an optional smartphone-based survey program to conduct health checks on early vaccine recipients — daily for the first week after vaccination and then weekly for six weeks.
Those reporting a “clinically important” adverse event will get a telephone follow-up, and a VAERS report will be taken if appropriate.
Kudish said DPH is encouraging vaccinators to hang information about V-safe where the vaccine is offered and encourage recipients to register, which can be done by scanning a QR code. She said DPH will try to get information on the percentage of people who opt in.
Dr. Keith Grant, senior system director of infection prevention for Hartford HealthCare, said this process needs to be stressed more.
“It was very easy for me to get the vaccine and go back to my office and not participate in what needs to be an extension of this process, to see how it’s going and to give confidence and really exemplify what our work is,” he said.
VAERS and V-Safe are for reporting, whereas there are other programs for the monitoring that follows. For example, the Vaccine Safety Datalink is a collaboration between the CDC’s Immunization Safety Office and nine health care organizations.
Kudish said the FDA’s system with the Centers for Medicare & Medicaid Services will capture a large amount of safety data for those over age 65, and a new initiative from Genesis HealthCare will capture safety information on long-term care facility residents.
She noted that DPH’s immunization program has a designated vaccine safety officer, and that DPH can pull weekly information reported into VAERS. She said Connecticut will begin to receive reports from the CDC this week.
“We have such a small percentage of the population, but it is good to monitor the portal, and we will be doing that to have some insight as to what’s going on here in Connecticut,” Kudish said.
She said if DPH hears reports separately, it will follow up with the CDC to make sure it received the report and will take down any information to help with the process.