Summary of Teratology Studies:
MAJOR CONGENITAL ANOMALIES
No epidemiological studies of congenital anomalies among infants born to women who received any type of COVID-19 vaccine during pregnancy have been reported.
PREGNANCY AND NEONATAL OUTCOMES
The rate of spontaneous abortion (12.6%) reported among 827 pregnant women in the v-safe pregnancy registry who received an mRNA COVID-19 vaccine in the first trimester was similar to that expected in the general population (Shimabukuro et al., 2021). In the same preliminary study, no neonatal deaths were reported among 724 liveborn infants of mothers who received an mRNA COVID-19 vaccine in the third trimester of pregnancy, and rates for preterm birth (9.4%), small for gestational age (3.2%), and stillbirth (0.1%) were similar to background population rates.
SARS-CoV-2 IgG antibodies were detectable in the cord blood of 25 out of 28 infants whose mothers were vaccinated with an mRNA vaccine in the third trimester of pregnancy in a prospective case-series (Mithal et al., 2021).
ANIMAL TERATOLOGY STUDIES
Animal teratology studies of COVID-19 vaccines conducted by the manufacturer have not been published in the peer-reviewed literature.
(Each paper is classified as a review [R], human case report [C], human epidemiological study [E], human clinical series [S], animal study [A], or other [O].)
Mithal LB, Otero S, Shanes ED, Goldstein JA, Miller ES: Cord blood antibodies following maternal coronavirus disease 2019 vaccination during pregnancy. Am J Obstet Gynecol 2021 Apr 1 (published online ahead of print). [S]
Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, Marquez PL, Olson CK, Liu R, Chang KT, Ellington SR, Burkel VK, Smoots AN, Green CJ, Licata C, Zhang BC, Alimchandani M, Mba-Jonas A, Martin SW, Gee JM, Meaney-Delman DM: Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. N Engl J Med 2021 Apr 21 (published online ahead of print). [E]
COVID-19 VACCINE PREGNANCY REGISTRIES
Healthcare providers are encouraged to enroll their patients, whether they have been given the vaccine or not, to the following registries:
A registry collecting health information from people who received COVID-19 vaccinations in the periconception period or during pregnancy is being maintained by the Centers for Disease Control. The registry attempts to assist individuals and healthcare providers to make informed decisions about COVID-19 vaccination.
Pregnant people who would like to participate must be enrolled in v-safe (a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccine. People who enroll in v-safe and report that they were pregnant at the time of vaccination or after vaccination, may be contacted by the registry staff for additional details.
COVID-PRICE (COVID-19 Pregnancy Related Immunological, Clinical, and Epidemiological Factors and Perinatal Outcomes)
A registry collecting health and exposure information from women who were diagnosed with COVID-19 or have received vaccinations against COVID-19 during pregnancy or while breastfeeding. The registry is maintained by Thomas Jefferson University in Philadelphia, Penn. It is a prospective cohort study of pregnant patients followed up to six weeks postpartum.
Healthcare providers may find more information about this registry here.
C-VIPER (COVID-19 Vaccines International Pregnancy Exposure Registry)
A registry collecting information from pregnant women who were vaccinated against COVID-19 during pregnancy and is maintained by Pregistry in Los Angeles, Calif. This registry evaluates obstetric, neonatal, and infant outcomes among women vaccinated during pregnancy to prevent COVID-19.
Healthcare providers may find additional information about this study here.