COVID-19 Vaccination Safety During Pregnancy
COVID-19 vaccination is recommended for all pregnant women as the benefits of vaccination outweigh the potential risks. 1
Risk of COVID-19 Infection During Pregnancy
- Pregnant women are at increased risk for severe COVID-19 disease and death compared to non-pregnant women of reproductive age 1
- COVID-19 infection during pregnancy is associated with adverse pregnancy outcomes including:
- Symptomatic pregnant women have 2-3 fold higher rates of ICU admission, invasive ventilation, and mortality from COVID-19 compared to symptomatic non-pregnant women 1
- Risk factors for severe COVID-19 in pregnancy include:
Current Recommendations
- CDC: COVID-19 vaccination is recommended for all people aged 12 years and older, including people who are pregnant, breastfeeding, trying to get pregnant, or might become pregnant in the future 1
- WHO: COVID-19 vaccination is recommended for pregnant women when the benefits outweigh the potential risks 1
Vaccine Safety in Pregnancy
- FDA label states: "Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy" 2
- Animal studies have shown no evidence of harm to the fetus due to the vaccine 2
- A developmental toxicity study in female rats receiving the equivalent of a single human dose of Pfizer-BioNTech COVID-19 Vaccine showed no vaccine-related adverse effects on female fertility, fetal development, or postnatal development 2
- Real-world data from 90,000 pregnant women collected through the V-safe COVID-19 vaccine pregnancy registry did not identify any safety signals 1
- Observational data confirm that the benefits of vaccination outweigh the potential risks 3
Timing of Vaccination
- There are currently no data to guide recommendations for vaccine administration at a particular gestational age 1
- In practice, many women receive the vaccine during the second or third trimester, as they may wish to avoid theoretical concerns around vaccination in the first trimester when organogenesis occurs 1
- WHO does not recommend pregnancy testing before vaccination or delaying/terminating pregnancy because of vaccination 1
Benefits to Infant
- Recent studies demonstrate placental transfer of vaccine-specific anti-SARS-CoV-2 IgG antibodies 1
- Anti-SARS-CoV-2 IgA and IgG antibodies have been detected in breast milk of vaccinated women for up to 6 weeks after the first vaccine dose 1
- Maternal vaccination during pregnancy has shown 61% effectiveness against COVID-19 hospitalization in infants aged <6 months 4
Vaccine Coverage and Disparities
- Vaccine coverage among pregnant women in the United States is estimated at 31% 1
- Vaccination rates are highest among women aged 35-49 years (22.7%) and lowest among those aged 18-24 years (5.5%) 5
- Higher vaccination rates are seen among non-Hispanic Asian (24.7%) and non-Hispanic White women (19.7%) compared to Hispanic (11.9%) and non-Hispanic Black women (6.0%) 5
Special Considerations
- For pregnant women with high-risk conditions (healthcare workers, age >35, multiple gestation, chronic medical conditions), vaccination is particularly important 1
- Contraindications to vaccination include severe allergic reaction to a previous dose or any component of the vaccine 1
Lactation Considerations
- It is not known whether Pfizer-BioNTech COVID-19 Vaccine is excreted in human milk 2
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vaccination 2
- Experts agree that vaccination poses minimal to no potential risk to the newborn during breastfeeding 1
In conclusion, while initial clinical trials excluded pregnant women, accumulated observational data strongly support the safety and benefits of COVID-19 vaccination during pregnancy. The risks of COVID-19 infection during pregnancy far outweigh any theoretical risks of vaccination.