The first large, real-world study of the effectiveness of mRNA COVID-19 vaccines during pregnancy found these vaccines, especially two initial doses followed by a booster, are effective in protecting against serious disease in expectant mothers whether the shots are administered before or during pregnancy.
Pregnant women were excluded from COVID-19 mRNA vaccine clinical trials, so this new study fills a significant knowledge gap, providing strong evidence that vaccinating women who are or might become pregnant protects against hospitalization for the disease during pregnancy.
"That two doses plus a booster are known to be safe and demonstrate protection against severe disease in pregnant women is reassuring, given growing evidence of increased risk of poor maternal outcomes associated with COVID-19 infection during pregnancy," said study co-author Brian Dixon, PhD, MPA, director of public health informatics for Regenstrief Institute and Indiana University Richard M. Fairbanks School of Public Health. "This strongly suggests that, along with other preventive measures that expectant mothers or women who are considering getting pregnant can take to promote a healthy pregnancy, getting vaccinated and boosted against COVID should be high on the list." Dr. Dixon also is the interim director of the Regenstrief Center for Biomedical Informatics.
The researchers found that mRNA COVID-19 vaccination protects pregnant women against emergency department (E.D.) or urgent care center visits and protects even more strongly against hospitalizations for COVID-19, three venues for receipt of medical attention for the disease. As with other evaluations of mRNA COVID-19 vaccines in adults, a lower effectiveness in protecting against E.D. and urgent care visits than for hospitalizations was seen in pregnant women, most significantly in the Omicron period among those receiving only two vaccine doses.
Also, similar to findings among non-pregnant adults, two-dose protection waned over time (after four months) and vaccine effectiveness was highest among pregnant women with three doses (initial two vaccinations plus a booster shot).
Data on a total of 3,445 E.D. or urgent care visits and 781 hospitalizations among pregnant women with COVID-19 confirmed by molecular testing was extracted from electronic medical records from 306 hospitals and 164 E.D. and urgent care facilities in eight health systems across 10 U.S. states. This information was analyzed by the VISION network, which includes Baylor Scott & White Health (Texas), Columbia University Irving Medical Center (New York), HealthPartners (Minnesota and Wisconsin), Intermountain Healthcare (Utah), Kaiser Permanente Northern California (California), Kaiser Permanente Northwest (Oregon and Washington), Regenstrief Institute (Indiana), and University of Colorado (Colorado).
"This study indicates that pregnancy doesn't diminish mRNA vaccine performance in protecting against severe COVID-19 despite immune differences between pregnant and non-pregnant women," said study co-author Shaun Grannis, M.D., M.S., vice president for data and analytics at Regenstrief Institute, Regenstrief Professor of Medical Informatics and professor of family medicine at Indiana University School of Medicine. "Vaccine utilization among expectant mothers remains low compared to similarly aged non-pregnant individuals for both the first two vaccines and a booster dose. Hopefully this study will provide pregnant women with the evidence they need to get vaccinated and boosted."
Current guidance from the Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists recommends that all pregnant women receive two vaccine doses and a booster dose, with a preference for mRNA vaccines.
"Estimation of COVID-19 mRNA Vaccine Effectiveness Against Medically Attended COVID-19 in Pregnancy During Periods of Delta and Omicron Variant Predominance in the United States" is published in JAMA Network Open.
Regenstrief Institute contributors to the study, in addition to Drs. Dixon and Grannis are William F. Fadel, PhD, Regenstrief Institute Center for Biomedical Informatics and IU Fairbanks School of Public Health; and Nimish R. Valvi, DrPH, Regenstrief Institute Center for Biomedical Informatics.
Authors of the study are Stephanie Schrag, DPhil, CDC COVID-19 Emergency Response Team; Jennifer R. Verani, M.D., CDC COVID-19 Emergency Response Team; Brian E. Dixon, PhD, Center for Biomedical Informatics, Regenstrief Institute, Fairbanks School of Public Health, Indiana University; Jessica M. Page, MD, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Intermountain Healthcare, University of Utah; Kristen A. Butterfield, MPH, Westat; Manjusha Gaglani, MBBS, Baylor Scott & White Health Temple, Texas A&M University College of Medicine; Gabriela Vazquez Benitez, PhD, HealthPartners Institute; Ousseny Zerbo, PhD, Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research; Karthik Natarajan, PhD, Department of Biomedical Informatics, Columbia University Irving Medical Center, New York-Presbyterian Hospital; Toan C. Ong, PhD, School of Medicine, University of Colorado Anschutz Medical Campus; Victoria Lazariu, PhD, Westat; Suchitra Rao, MBBS, School of Medicine, University of Colorado Anschutz Medical Campus; Ryan Beaver, D.O., Baylor Scott & White Health Temple; Sascha R. Ellington, PhD, CDC COVID-19 Emergency Response Team; Nicola P. Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research; Stephanie A. Irving, MHS, Center for Health Research, Kaiser Permanente Northwest; Shaun J. Grannis, MD, Center for Biomedical Informatics, Regenstrief Institute, Indiana University School of Medicine; Salome Kiduko, MPH, Westat; Michelle A. Barron, MD, School of Medicine, University of Colorado Anschutz Medical Campus; John Midturi, D.O., Baylor Scott & White Health Temple; Monica Dickerson, CDC COVID-19 Emergency Response Team; Ned Lewis, MPH, Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research; Melissa Stockwell, MD, New York-Presbyterian Hospital, Division of Child and Adolescent Health, Department of Pediatrics, Columbia University Vagelos College of Physicians and Surgeons, Department of Population and Family Health, Columbia University Mailman School of Public Health; Edward Stenehjem, MD, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Intermountain Healthcare, University of Utah; William F. Fadel, PhD, Center for Biomedical Informatics, Regenstrief Institute, Fairbanks School of Public Health, Indiana University; Ruth Link-Gelles, CDC COVID-19 Emergency Response Team; Kempapura Murthy, MBBS, Baylor Scott & White Health Temple; Kristin Goddard, MPH, Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research; Nancy Grisel, MPP, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Intermountain Healthcare, University of Utah; Nimish R. Valvi, DrPH, Center for Biomedical Informatics, Regenstrief Institute; Bruce Fireman, Kaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California Division of Research; Julie Arndorfer, MPH, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Intermountain Healthcare, University of Utah; Deepika Konatham, Baylor Scott & White Health Temple; Sarah Ball, PhD, Westat; Mark G. Thompson, PhD, CDC COVID-19 Emergency Response Team; and Allison L. Naleway, PhD, Center for Health Research, Kaiser Permanente Northwest.
This work was supported by the U.S. Centers for Disease Control and Prevention (CDC).
About Brian E. Dixon, PhD, MPA
In addition to his role as the interim director of the Clem McDonald Center for Biomedical Informatics at Regenstrief and director of public health informatics for Regenstrief Institute and Indiana University Richard M. Fairbanks School of Public Health, Brian E. Dixon, PhD, MPA is a research scientist at Regenstrief and a professor of epidemiology at the Fairbanks School of Public Health. He is also an affiliate scientist at the U.S. Department of Veterans Affairs Health Services Research and Development Center for Health Information and Communication, Richard L. Roudebush VA Medical Center.
About Shaun Grannis, M.D., M.S.
In addition to his role as the vice president for data and analytics at Regenstrief Institute, Shaun Grannis, M.D., M.S., is the Regenstrief Professor of Medical Informatics and a professor of family medicine at Indiana University School of Medicine.
About Regenstrief Institute
Founded in 1969 in Indianapolis, the Regenstrief Institute is a local, national and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its research scientists are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.
Sam Regenstrief, a nationally successful entrepreneur from Connersville, Indiana, founded the institute with the goal of making healthcare more efficient and accessible for everyone. His vision continues to guide the institute's research mission.
About the Richard M. Fairbanks School of Public Health
Located on the IUPUI and Fort Wayne campuses, the Richard M. Fairbanks School of Public Health is committed to advancing the public's health and well-being through education, innovation and leadership. The Fairbanks School of Public Health is known for its expertise in biostatistics, epidemiology, cancer research, community health, environmental public health, global health, health policy and health services administration.
About IU School of Medicine
IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.
