The Centers for Disease Prevention and Control selected Kaiser Permanente’s Vaccine Study Center to conduct an ongoing analysis of Covid-19 vaccine data in an effort to identify potential adverse reactions.
Part of the Kaiser Permanente Northern California Division of Research, the study center will conduct a rapid cycle analysis of data shared through the CDC’s Vaccine Safety Datalink network. Several organizations share data through the network, including five Kaiser Permanente regions, HealthPartners in Minneapolis and the Marshfield Clinic in Wisconsin.
The rapid cycle analysis involves assessing weekly data reports from the Vaccine Safety Datalink network. These analyses use selected diagnoses from EHRs and search for possible associations between those diagnoses and having received the Covid-19 vaccine, Dr. Nicola Klein, director of the Vaccine Study Center, said in an email.
The analyses will focus on identifying potential adverse reactions to the vaccine, such as strokes or severe allergic reactions.
“The analysts looks for rates of specific adverse outcomes and compare them with the number that would be typically expected in a given patient population,” Klein said. “In other words, they look for excess cases of particular diagnoses or outcomes. The intent is to provide population-level surveillance for potential serious adverse reactions to a Covid-19 vaccine.”
For example, the center’s analysts will drill down on specific conditions — like heart attacks — and see if there has been an increase in cases. If there has been a rise, the analysts will examine whether it is linked to receiving the Covid-19 vaccine.
Kaiser Permanente’s Vaccine Study Center has experience with this sort of analysis, having been involved in evaluating vaccines for more than three decades. In 2008, Klein’s team discovered there was an increase in fever seizure in toddlers who received a combination measles, mumps, rubella and varicella vaccine using the rapid cycle analysis approach, according to a Kaiser Permanente news release.
The center has started the rapid cycle analysis of Covid-19 vaccine data, which will continue for the next three years, “but given the fluid nature of the Covid-19 pandemic, the specifics of the rapid cycle analysis may evolve over time,” Klein added.
Results of the analysis will be shared weekly within the Vaccine Safety Datalink network, which includes CDC representatives. Any potential concerns will also be discussed by the CDC’s Advisory Committee on Immunization Practices.
As of Jan. 11, 25 million doses of the Covid-19 vaccine have been distributed across the country, and 8.9 million people have received their first dose, according to CDC data. But, the vaccine distribution appears to be moving slowly in comparison with how quickly cases are rising — the seven-day moving average of Covid-19 cases in the U.S. was 244,702 as of Jan. 10, the data shows.
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