Kaiser to Track Serious Adverse Events From COVID-19 Vaccination

January 13, 2021 - Kaiser Permanente Vaccine Study Center, part of the company’s Northern California Division of Research, recently announced that it will oversee electronic patient records and uncover any adverse health events due to COVID-19 vaccination. 

The Center will carry out a Rapid Cycle Analysis (RCA) through the CDC’s Vaccine Safety Datalink (VSD) network. The healthcare organizations that participate in the VSD and share weekly reports on the selected diagnoses include five Kaiser Permanente regions, HealthPartners in Minneapolis, and the Marshfield Clinic in Wisconsin.

Data analysts are looking to find connections between a diagnosis that indicates a serious adverse event and a COVID-19 vaccination.

Rather than focusing on mild side effects that have been previously reported with the two FDA-approved COVID-19 vaccines from Pfizer/BioNTech and Moderna, analysts will look at any serious adverse events and compare them with the number that would generally be expected in a specific population.

One of the notable adverse events being monitored is heart attack. It is currently unclear if the coronavirus vaccine poses a risk to cardiovascular events. And although serious adverse events do not mean a patient is infected with the virus, it can be an indication that their immune system is responding to the vaccine.

“We’ll monitor to see if there are excess cases, and if so, whether an increased risk is associated with a COVID-19 vaccine,” Nicola Klein, MD, PhD, director of Kaiser Permanente’s Vaccine Study Center, said in the announcement. “The Vaccine Safety Datalink is the premier system in the United States, and arguably in the world, for active, real-time safety surveillance of vaccines.”

“Kaiser Permanente’s Vaccine Study Center is really well suited to carry out this Rapid Cycle Analysis because we are experienced doing these analyses, and actually found a safety finding in the past,” Klein continued. 

Kaiser Permanente’s Vaccine Study Center has been evaluating vaccines for over 30 years and carrying out response studies through VSD for over 10 years. 

In 2008, Klein explained that she and her colleagues identified an increase in fever seizures in toddlers who received a combination measles, mumps, rubella, and varicella (MMRV) vaccine using the same RCA approach that is being used for COVID-19 vaccinations. 

The analyses related to COVID-19 are expected to begin soon now that individuals are receiving the Pfizer/ BioNTech and Moderna vaccines. Specifically, researchers have finalized a list of outcomes to be tracked.

“The spirit of our data analyses and surveillance is the same as usual, but we expect that there will be more visibility within the VSD network, the CDC, and the public about our findings,” Klein stated. 

The weekly VSD analyses are one part of the government’s effort to monitor the safety of the new COVID-19 vaccines as they are rolled out for general use. If concerns about new adverse events due to a COVID-19 vaccine arise over time, they can be added to VSD’s surveillance list.

So far, nearly 9 million people have received the first dose of Pfizer/BioNTech or Moderna’s respective COVID-19 vaccines in the US, according to the CDC. 

In September, HHS and the Department of Defense (DoD) released two documents outlining the Trump Administration’s COVID-19 vaccine distribution strategy as promising vaccines were progressing through clinical trials. 

The documents provide four necessary tasks to guide public health programs on how to strategically plan and operationalize a vaccination response to COVID-19.

So far, the US has surpassed steps one and two, which were to communicate information around the vaccines, promote vaccine uptake, and begin distributing vaccines upon emergency use authorization.

The third task, the task that the US is currently facing, is to ensure safe administration of the approved vaccines and availability of administration supplies.

And finally, the fourth task is to monitor necessary data from the vaccination program through an IT system capable of supporting and tracking distribution, administration, and other data.