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Coronavirus Disease 2019 (COVID-19) Vaccines and Pregnancy: What Obstetricians Need to Know
Sonja A Rasmussen1, Colleen F Kelley, John P Horton
1Departments of Pediatrics, Obstetrics and Gynecology, and Epidemiology, University of Florida College of Medicine and College of Public Health and Health Professions, Gainesville, Florida; and the Division of Infectious Diseases and the Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, the Grady Healthcare System, Infectious Diseases Program, Atlanta, and the Hope Clinic of the Emory Vaccine Center, Decatur, Georgia.
Insights
Pregnant individuals need guidance on COVID-19 vaccines. Limited data exists, but available information helps weigh benefits against risks for expectant mothers and their babies.
Area of Science:
- Obstetrics and Gynecology
- Vaccinology
- Infectious Diseases
Background:
- Coronavirus disease 2019 (COVID-19) vaccines are being distributed, with initial priority for healthcare workers and long-term care residents.
- Pregnant individuals were excluded from initial COVID-19 vaccine clinical trials, resulting in limited safety and efficacy data during pregnancy.
Purpose of the Study:
- To address the need for guidance on COVID-19 vaccine administration in pregnant individuals.
- To outline factors for healthcare providers and pregnant patients to consider when evaluating COVID-19 vaccine benefits and risks.
Main Methods:
- Review of available data, including animal studies and inadvertently exposed pregnancies.
- Consideration of vaccine reactogenicity, timing, and established safety of other vaccines in pregnancy.
- Assessment of COVID-19 risks for pregnant individuals and potential mitigation strategies.
Main Results:
- Professional organizations (CDC, ACOG, SMMFM) support offering COVID-19 vaccines to pregnant individuals.
- Decision-making requires weighing potential risks of vaccination against the risks of COVID-19 infection during pregnancy.
Conclusions:
- Pregnant individuals and their obstetricians must utilize current data to make informed vaccination decisions.
- Ongoing monitoring of clinical trial data and real-world evidence from vaccinated pregnant individuals is crucial.
- Healthcare providers need to stay updated on emerging information regarding COVID-19 vaccines in pregnancy.
Abstract:
Coronavirus disease 2019 (COVID-19) vaccines have begun to be distributed across the United States and to be offered initially to priority groups including health care personnel and persons living in long-term care facilities. Guidance regarding whether pregnant persons should receive a COVID-19 vaccine is needed. Because pregnant persons were excluded from the initial phase 3 clinical trials of COVID-19 vaccines, limited data are available on their efficacy and safety during pregnancy. After developmental and reproductive toxicology studies are completed, some companies are expected to conduct clinical trials in pregnant persons. Until then, pregnant persons and their obstetricians will need to use available data to weigh the benefits and risks of COVID-19 vaccines. Issues to be considered when counseling pregnant persons include data from animal studies and inadvertently exposed pregnancies during vaccine clinical trials when available, potential risks to pregnancy of vaccine reactogenicity, timing of vaccination during pregnancy, evidence for safety of other vaccines during pregnancy, risk of COVID-19 complications due to pregnancy and the pregnant person's underlying conditions, and risk of exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and potential for risk mitigation. The Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine have each issued guidance supportive of offering COVID-19 vaccine to pregnant persons. As additional information from clinical trials and from data collected on vaccinated pregnant persons becomes available, it will be critical for obstetricians to keep up to date with this information.
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