What We Do
We help protect public health with the following programs:
Pre-licensure Clinical Trials
We conduct studies for manufacturers who are developing new vaccines that are not yet licensed. Our role is to examine how the vaccines work and how effective they are. Study participants are drawn from our large population of Kaiser Permanente members. We carry out randomized, controlled clinical trials at many different Kaiser Permanente medical facilities, under the direction of full-time clinical research registered nurses, with oversight from physicians at each facility. The information from these trials goes to the Food and Drug Administration (FDA), which decides whether or not to license the vaccine.
Post-licensure Surveillance Studies
Once the vaccine is licensed and marketed, the FDA requires the manufacturer to conduct another study with larger numbers of participants to test the vaccine's safety in real-world use. We monitor the records of vaccine recipients, using a variety of studies that we design and carry out, to make sure the vaccine is safe.
Collaboration with Federal Partners
We collaborate with the following operating divisions of the United States Department of Health and Human Services (DHHS):
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
Centers for Disease Control and Prevention (CDC)
Our work for the CDC involves vaccine surveillance and retrospective research examining vaccine safety.
We collaborate with CDC's Immunization Safety Office (ISO), which includes the following:
- Vaccine Safety Datalink (VSD) Project
- Clinical Immunization Safety Assessment (CISA) Network
- Vaccine Adverse Event Reporting System (VAERS) – See Food and Drug Administration, below
The Kaiser Permanente Vaccine Study Center is the only organization in the country that participates in both the CISA Network and the VSD Project.
In partnership with the CDC and other large health care organizations, we conduct studies of vaccine safety using large linked databases. This approach enables us to study large numbers of people who have received a vaccine to determine whether they have had any adverse outcomes. Studying large populations is particularly important for detecting the possibility of a relationship between vaccines and adverse events, such as illnesses, especially if the adverse event is rare.
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In partnership with the CDC and six academic medical research centers throughout the United States, we examine the physiological mechanisms of adverse reactions to vaccines and the risk factors associated with having an adverse event following immunization (AEFI). CISA also counsels clinicians about vaccine safety and is developing evidence-based evaluation guidelines for clinicians.Learn more »
Food and Drug Administration (FDA)
We participate with other research organizations in the Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program co-sponsored by the CDC and the FDA. As part of VAERS, we help gather, analyze and disseminate information about possible adverse outcomes that occur after vaccines licensed for use in the United States have been administered. VAERS also disseminates information about vaccine safety.
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We collaborate with other researchers, industry, and government to study the impact of a disease on the public and to assess whether or not the impact is sufficiently serious and widespread to warrant developing a new vaccine to prevent the disease.
Surveillance of Influenza and other Respiratory Viruses
Respiratory viruses, including influenza and respiratory syncytial virus (RSV), have a significant impact on public health, and bring outbreaks of respiratory disease every winter. For many years, the Kaiser Permanente Vaccine Study Center has tracked these viruses and their impact on our members. We send memos to all our physicians giving them the most current information about how to test and treat patients. We know before anyone else in the state when the flu season begins.
Studies of Vaccine Effectiveness
Our studies seek to determine how well vaccines prevent the illness they are designed to prevent. We have developed new, more precise epidemiological methods for assessing the effectiveness of the flu vaccine. Our new methods address certain biases in data that have affected such studies in the past. We are grateful to
Kaiser Permanente's Community Benefit Program for supporting this work.
Studies of Vaccine Safety in Special Populations
We conduct studies specifically evaluating the safety of vaccines administered to children in special populations. These can include infants and children such as babies born prematurely or children with genetic or chronic medical conditions. These children are vulnerable to becoming very sick from vaccine-preventable diseases, but there have been limited numbers of studies investigating the safety of vaccinating this fragile population.
Genetics of Vaccine Responses and Adverse Events Following Immunization
We are very interested in studies evaluating genomic influences on both vaccine responses and vaccine adverse events.