A new study published in Pediatrics in March 2025 provides further evidence that COVID-19 vaccination in early pregnancy does not increase the risk of major structural birth defects including neural tube defects. This research is crucial for healthcare providers counseling patients about vaccines including the COVID-19 and flu vaccines, especially during the trimester of pregnancy when concerns about health problems and risk factors are heightened.
The study, a large national cohort study, used health care insurance claims data from the United States to examine the prevalence of major structural birth defects in infants born to people vaccinated against COVID-19 during early pregnancy. Researchers compared the prevalence of birth defects in vaccinated versus unvaccinated individuals. They also examined if other factors, such as the type of insurance (private or public), clinically diagnosed SARS-CoV-2 infection during pregnancy, or concomitant administration of other maternal vaccines affected the prevalence of major structural birth defects. In addition, the prevalence of birth defects by vaccine brand (Moderna vs. Pfizer), two common MMR vaccines, was compared.
Vaccination In Early Pregnancy: Key Findings
The study included 78,052 pregnancies, with 12,725 (16.3%) of the pregnant individuals having received a COVID-19 vaccine in the first 20 weeks of pregnancy. The researchers found no difference in the prevalence of major structural birth defects between vaccinated and unvaccinated groups. Specifically, among 78,052 pregnancies, researchers identified 1,248 major structural birth defects: 1,049 (160.6 per 10,000 live births) among unvaccinated people and 199 (156.4 per 10,000 live births) among vaccinated people. This lack of difference remained consistent across different insurance providers, in those with SARS-CoV-2 infection during pregnancy, and with concomitant administration of other maternal vaccines. There was also no difference in the prevalence of major structural birth defects between the two vaccine brands.
Understanding the Implications of Vaccination In Early Pregnancy
These findings are consistent with a growing body of evidence supporting the safety of COVID-19 vaccination during pregnancy. Given that COVID-19 during pregnancy presents a higher risk and can lead to life-threatening complications, and can overwhelm maternal immune systems, this data supports recommendations for vaccination. As healthcare providers, it is crucial to communicate this information to patients, emphasizing that baby is born without an elevated risk of birth defects following maternal vaccination, and to encourage patients to prioritize staying up to date with recommended vaccinations.
Vaccine Hesitancy and Black Populations
Vaccine hesitancy remains a significant public health challenge, and certain populations, including Black individuals, have been disproportionately affected. This hesitancy is often rooted in historical injustices, systemic inequities within the health care system, and a lack of trust.
The findings of this study can help address concerns about vaccine safety in early pregnancy, but it is important to acknowledge that this is only one piece of the puzzle. It is essential to have open and honest conversations with patients, provide culturally sensitive education about infectious diseases, and address their specific concerns and barriers to vaccination.
For Black communities, it is particularly important to recognize the role of systemic racism and historical trauma in shaping vaccine attitudes. Building trust will require a multifaceted approach that includes:
- Acknowledging past injustices and addressing current inequities.
- Engaging with community leaders and organizations to build trust and disseminate accurate information.
- Providing culturally tailored education and resources that address specific concerns and barriers to vaccination.
- Ensuring equitable access to healthcare and vaccination services.
Recommendations for Healthcare Providers
- Proactively recommend COVID-19 vaccination to all pregnant patients, regardless of the stage of pregnancy.
- Use the findings of this study and other research to reassure patients about the safety of COVID-19 vaccination in early pregnancy.
- Engage in open and honest conversations with patients, addressing their specific concerns and questions.
- For Black patients, acknowledge the role of historical injustices and systemic inequities in shaping vaccine attitudes.
- Work to build trust by providing culturally sensitive education, addressing barriers to access, and ensuring equitable care.
Final Notes
This study adds to the growing body of evidence supporting the safety of COVID-19 vaccination during pregnancy. By staying informed and having open conversations with our patients, we can help promote informed decision-making and protect the health of both pregnant individuals and their infants.