Examining the evidence on vaccine safety
We are part of the Vaccine Safety Datalink (VSD), a collaboration between the Centers for Disease Control and Prevention and several large health care systems, including HealthPartners.
Since 2014, our Institute VSD team has led several large observational studies. Findings from this research have been presented at national conferences and to the Advisory Committee on Immunization Practices (ACIP). ACIP is a group of medical and public health experts that develop recommendations on use of vaccines for people in the United States.
Recently, our team has been studying the safety and effectiveness of COVID-19 vaccines in general, and when given during pregnancy. We also completed a National Institutes of Health (NIH)-funded study of the safety of influenza vaccine in children with asthma.
Investigators
Key projects
COVID-19 mRNA vaccines not linked to increased risk of miscarriage
We led a study of new surveillance data that showed mRNA vaccines given during pregnancy did not increase the risk of miscarriage. The data suggest that COVID-19 vaccines are safe for people who are pregnant. The pregnancy data came from HealthPartners and eight other large health systems that are part of the VSD.
Study of 6.2 million patients shows mRNA vaccines are safe
This study, co-authored by an Institute researcher, validates existing safety data and provides reassurance to those who may be hesitant to get vaccinated. Researchers looked at 23 potential side effects that were monitored during vaccine clinical trials and reported among those who received the vaccines. After complex statistical analyses, researchers found that neither mRNA vaccine in use produced any recurring concerns.
Effectiveness of COVID-19 vaccines against Delta variant
We co-authored two studies on the effectiveness of COVID-19 vaccines against the Delta variant. Researchers looked at 30,000 urgent care visits, emergency department visits, and hospital admissions during June and July 2021, after the Delta variant was widely circulating in the United States. They determined that the effectiveness of the vaccines against COVID-19 hospitalizations and emergency and urgent care encounters remained similar to the vaccine effectiveness prior to the Delta variant predominance.
Phase 3 clinical trial for a COVID-19 vaccine
In September 2020, we began participation in the AstraZeneca COVID-19 vaccine trial. We were the first site in Minnesota to participate in a COVID-19 vaccine trial, chosen because of our strengths as an integrated system with nationally recognized clinical research expertise. Among the roughly 100 research institutions participating in the trial, our organization was one of the highest enrolling sites. Our trial participants reflected the diverse community we serve, with more than 36 percent of participants from communities of color. This diverse representation leads to better science and, ultimately, better health. Data published in the New England Journal of Medicine (NEJM) show the AstraZeneca COVID-19 vaccine is highly effective at protecting against the virus. The AstraZeneca COVID-19 vaccine is effective, affordable, relatively easy to store and critical to helping prevent COVID-19 around the world.
Safety of influenza and pertussis vaccines when given during pregnancy
The influenza and pertussis vaccines are recommended for all women during pregnancy. As part of the VSD, we led a series of studies to assess the safety of this practice. We examined mother and infant outcomes after vaccination in pregnancy. Overall, our research supports the safety of current vaccine recommendations to give pregnant women influenza and pertussis vaccines.
Safety of inadvertent exposures to HPV vaccine during pregnancy
The human papillomavirus (HPV) vaccine is not recommended in pregnancy. However, it is necessary for women of child bearing age and for those who are accidentally exposed to HPV during or around the time of pregnancy. As part of the VSD, we are currently studying whether accidental HPV exposures in pregnancy are associated with increased risk of fetal death.
Safety of live attenuated influenza vaccine in children with asthma
Children with asthma are at high risk for complications from influenza. In this study, we demonstrated the safety of a policy to administer live attenuated influenza vaccine in children with asthma. This study was funded by the National Institute of Allergy and Infectious Disease, as part of the NIH.
Key publications
Learn more about our Vaccine investigators and their publications by visiting Knowledge Exchange.
