TERIS Agent
Updated: 05/2023
COVID-19 mRNA VACCINES
COVID-19 vaccines provide protection against the COVID-19 virus, SARS-CoV-2, and are administered by injection. Several different COVID-19 vaccines have been developed.
Messenger ribonucleic acid (mRNA) vaccines use mRNA as the genetic vector to encode a spike protein of SARS-CoV-2, the protein found on the surface of the virus, to trigger an immune response. The mRNA does not enter the nucleus and therefore does not integrate into the DNA. The mRNA is degraded into the cell cytoplasm within hours to days after injection.
Messenger ribonucleic acid (mRNA) vaccines use mRNA as the genetic vector to encode a spike protein of SARS-CoV-2, the protein found on the surface of the virus, to trigger an immune response. The mRNA does not enter the nucleus and therefore does not integrate into the DNA. The mRNA is degraded into the cell cytoplasm within hours to days after injection.
Magnitude of Teratogenic Risk to Child Born After Exposure During Gestation
NONE
Quality and Quantity of Data on Which Risk Estimate is Based
GOOD
Comments
NONE.
Summary of Available Literature:
MAJOR CONGENITAL ANOMALIES
The rates of major malformations overall, and of congenital heart defects specifically, were no different among liveborn infants of 2134 mothers who were vaccinated with an mRNA COVID-19 vaccine in the first trimester of pregnancy and the infants of 3584 unvaccinated pregnant women in a large cohort study conducted in Israel (Goldshtein et al., 2022). In a record-linkage study from Scotland, congenital anomalies of non-genetic causes were reported in 84 (1.5%) of 5498 liveborn infants whose mothers were vaccinated with an mRNA COVID-19 vaccine anytime shortly before and up to 20 weeks of pregnancy compared to 309 (1.9%) infants of 16949 unvaccinated pregnant women (adjusted odds ratio=0.85, 95% confidence interval 0.66-1.10) (Calvert et al., 2023).
In a retrospective cohort study based on data from electronic medical records, the rate of major congenital anomalies identified on second trimester ultrasonography among fetuses of 1149 women who received at least one dose of a COVID-19 vaccine anytime 30 days before conception through 14 weeks of gestation was similar to that seen in the fetuses of 2007 women who were unvaccinated or vaccinated outside the first trimester (adjusted odds ratio=1.01, 95% confidence interval 0.69-1.48) (Ruderman et al., 2022). No teratogenic effect was found when the window of exposure was narrowed down to two to ten weeks gestation. Although the authors of this study do not specify how many women actually received a COVID-19 mRNA vaccine, it can be safety presumed based on the location and timing of the study that the majority were immunized with a COVID-19 mRNA vaccine. Another record-linkage study from Australia reported no significant difference in the frequency of congenital anomalies among the infants of 2442 women vaccinated with an mRNA COVID-19 vaccine in the first half of pregnancy compared to infants of 2668 unvaccinated women (Hui et al., 2023).
PREGNANCY AND NEONATAL OUTCOMES
Several systematic reviews and meta-analyses of epidemiological studies reporting on more than 127,273 vaccinated pregnancies--almost exclusively with mRNA vaccines--showed no significant differences in the overall frequency of adverse pregnancy and neonatal outcomes (spontaneous abortion, preterm birth, low birth weight, small for gestational age, NICU admission, and low Apgar scores) between vaccinated and unvaccinated pregnancies (Carbone et al., 2022; Ma et al., 2022; Prasad et al., 2022; Watanabe et al., 2022; Ding et al., 2023; Tormen et al., 2023; Zhang et al., 2023). In fact, the incidence of some of these adverse outcomes, including stillbirth and preterm birth, were slightly reduced among vaccinated women compared to the rates seen in the unvaccinated group in some of these studies (Carbone et al., 2022; Prasad et al., 2022; Watanabe et al., 2022). Some of the studies included in those meta-analyses and reviews are discussed below.
The cumulative risk of spontaneous abortion (14.1%, 95% confidence interval 12.1-16.1) reported among 2456 pregnant women in the v-safe pregnancy registry who had received at least one dose of an mRNA COVID-19 vaccine either before conception or before 20 weeks of gestation was similar to that expected in the general population, and remained in the expected range in a secondary analysis using maternal age-standardization to the reference population (12.8%, 95% confidence interval 10.8-14.8) (Zauche et al., 2021). Similarly, the cumulative risk of spontaneous abortion (13.5%) among 6840 pregnant women in the Vaccines International Pregnancy Exposure Registry (C-VIPER) was similar to the expected risk in the general population (Mansour et al., 2023). In two subsequent retrospective cohort studies, administration of an mRNA COVID-19 vaccine was not associated with a risk of early pregnancy loss among a total of 1149 vaccinated women compared to unvaccinated women (Aharon et al., 2022; Citu et al., 2022). No association was found with spontaneous abortions in a Scottish record-linkage study with a total of 15,935 women vaccinated with a mRNA COVID-19 vaccine shortly before conception or anytime through 19 weeks post-gestation (Calvert et al., 2022). No evidence of an increased rate of spontaneous abortion following first trimester COVID-19 mRNA vaccination was found in other reports (Magnus et al., 2021; Trostle et al., 2021).
In a European pharmacovigilance study, the frequency of spontaneous abortion was lower among 2612 pregnant women who received an mRNA vaccine compared to 619 women who received a COVID-19 viral vector vaccine (odds ratio=0.80, 95% confidence interval 0.69-0.93) (Mascolo et al., 2022). In a case-control surveillance study, with a total of 112,718 pregnancies, the odds of having received a third mRNA COVID-19 booster vaccination within 28 days of a spontaneous abortion was not increased compared to ongoing pregnancies (Kharbanda et al., 2023). In fact, a protective effect of the third booster vaccination was seen in subsequent analyses of the data (odds ratio=0.78, 95% confidence interval 0.69-0.89) (Vazquez-Benitez et al., 2023).
In a preliminary study of the v-safe pregnancy registry, 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 (Shimabukuro et al., 2021). Similarly, no significant differences in early infant morbidity or mortality were detected among 16,697 liveborn infants who were prenatally exposed to an mRNA vaccine compared to liveborn infants born to 7591 unvaccinated pregnant women in a large cohort study in Israel (Goldshtein et al., 2022). In other population-based studies conducted in Canada, Israel, Malaysia, Sweden, Norway, and the United Kingdom, vaccination against SARS-CoV-2 during pregnancy was not significantly associated with an increased risk of adverse pregnancy and neonatal outcomes, including stillbirth, small for gestational age, preterm delivery, low Apgar scores, or NICU admission, compared to the outcome of unvaccinated pregnant women (Arulappen et al., 2022; Blakeway et al., 2022; Fell et al., 2022; Magnus et al., 2022; Sadarangani et al., 2022; Kugelman et al., 2023). Most of the vaccinations in those studies were mRNA COVID-19 vaccines and were given during the second and third trimesters of pregnancy.
Three cohort studies from Mexico, Australia, and the United States reported significantly reduced incidences of stillbirth and preterm birth among a total of more than 46,226 vaccinated pregnant women with an mRNA vaccine compared to unvaccinated women (Piekos et al., 2022; Hui et al., 2023; Morgan et al., 2023).
TRANSPLACENTAL PASSAGE OF SARS-CoV-2 ANTIBODIES
Several studies reported SARS-CoV-2 IgG antibodies being detectable in the cord blood of infants whose mothers were vaccinated with an mRNA vaccine in the second half of pregnancy (Gray et al., 2021; Mithal et al., 2021; Rottenstreich et al., 2021; Kassis et al., 2022; Shook et al., 2022). Evidence of transplacental passage following vaccination in early pregnancy has also been demonstrated in some other reports (Atyeo et al., 2022; Rottenstreich et al., 2022; Sourouni et al., 2022).
ANIMAL TERATOLOGY STUDIES
No teratogenic or other adverse fetal effects were observed among the offspring of mice and rats injected with mRNA-1273 vaccine during early pregnancy with 50-300 times greater doses than those used in humans (Bowman et al., 2021; Lu-Culligan et al., 2022). In both studies, pregnant dams vaccinated prior to placental establishment and fetal circulation conferred fetal transfer of antibodies up to the time of birth.
The rates of major malformations overall, and of congenital heart defects specifically, were no different among liveborn infants of 2134 mothers who were vaccinated with an mRNA COVID-19 vaccine in the first trimester of pregnancy and the infants of 3584 unvaccinated pregnant women in a large cohort study conducted in Israel (Goldshtein et al., 2022). In a record-linkage study from Scotland, congenital anomalies of non-genetic causes were reported in 84 (1.5%) of 5498 liveborn infants whose mothers were vaccinated with an mRNA COVID-19 vaccine anytime shortly before and up to 20 weeks of pregnancy compared to 309 (1.9%) infants of 16949 unvaccinated pregnant women (adjusted odds ratio=0.85, 95% confidence interval 0.66-1.10) (Calvert et al., 2023).
In a retrospective cohort study based on data from electronic medical records, the rate of major congenital anomalies identified on second trimester ultrasonography among fetuses of 1149 women who received at least one dose of a COVID-19 vaccine anytime 30 days before conception through 14 weeks of gestation was similar to that seen in the fetuses of 2007 women who were unvaccinated or vaccinated outside the first trimester (adjusted odds ratio=1.01, 95% confidence interval 0.69-1.48) (Ruderman et al., 2022). No teratogenic effect was found when the window of exposure was narrowed down to two to ten weeks gestation. Although the authors of this study do not specify how many women actually received a COVID-19 mRNA vaccine, it can be safety presumed based on the location and timing of the study that the majority were immunized with a COVID-19 mRNA vaccine. Another record-linkage study from Australia reported no significant difference in the frequency of congenital anomalies among the infants of 2442 women vaccinated with an mRNA COVID-19 vaccine in the first half of pregnancy compared to infants of 2668 unvaccinated women (Hui et al., 2023).
PREGNANCY AND NEONATAL OUTCOMES
Several systematic reviews and meta-analyses of epidemiological studies reporting on more than 127,273 vaccinated pregnancies--almost exclusively with mRNA vaccines--showed no significant differences in the overall frequency of adverse pregnancy and neonatal outcomes (spontaneous abortion, preterm birth, low birth weight, small for gestational age, NICU admission, and low Apgar scores) between vaccinated and unvaccinated pregnancies (Carbone et al., 2022; Ma et al., 2022; Prasad et al., 2022; Watanabe et al., 2022; Ding et al., 2023; Tormen et al., 2023; Zhang et al., 2023). In fact, the incidence of some of these adverse outcomes, including stillbirth and preterm birth, were slightly reduced among vaccinated women compared to the rates seen in the unvaccinated group in some of these studies (Carbone et al., 2022; Prasad et al., 2022; Watanabe et al., 2022). Some of the studies included in those meta-analyses and reviews are discussed below.
The cumulative risk of spontaneous abortion (14.1%, 95% confidence interval 12.1-16.1) reported among 2456 pregnant women in the v-safe pregnancy registry who had received at least one dose of an mRNA COVID-19 vaccine either before conception or before 20 weeks of gestation was similar to that expected in the general population, and remained in the expected range in a secondary analysis using maternal age-standardization to the reference population (12.8%, 95% confidence interval 10.8-14.8) (Zauche et al., 2021). Similarly, the cumulative risk of spontaneous abortion (13.5%) among 6840 pregnant women in the Vaccines International Pregnancy Exposure Registry (C-VIPER) was similar to the expected risk in the general population (Mansour et al., 2023). In two subsequent retrospective cohort studies, administration of an mRNA COVID-19 vaccine was not associated with a risk of early pregnancy loss among a total of 1149 vaccinated women compared to unvaccinated women (Aharon et al., 2022; Citu et al., 2022). No association was found with spontaneous abortions in a Scottish record-linkage study with a total of 15,935 women vaccinated with a mRNA COVID-19 vaccine shortly before conception or anytime through 19 weeks post-gestation (Calvert et al., 2022). No evidence of an increased rate of spontaneous abortion following first trimester COVID-19 mRNA vaccination was found in other reports (Magnus et al., 2021; Trostle et al., 2021).
In a European pharmacovigilance study, the frequency of spontaneous abortion was lower among 2612 pregnant women who received an mRNA vaccine compared to 619 women who received a COVID-19 viral vector vaccine (odds ratio=0.80, 95% confidence interval 0.69-0.93) (Mascolo et al., 2022). In a case-control surveillance study, with a total of 112,718 pregnancies, the odds of having received a third mRNA COVID-19 booster vaccination within 28 days of a spontaneous abortion was not increased compared to ongoing pregnancies (Kharbanda et al., 2023). In fact, a protective effect of the third booster vaccination was seen in subsequent analyses of the data (odds ratio=0.78, 95% confidence interval 0.69-0.89) (Vazquez-Benitez et al., 2023).
In a preliminary study of the v-safe pregnancy registry, 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 (Shimabukuro et al., 2021). Similarly, no significant differences in early infant morbidity or mortality were detected among 16,697 liveborn infants who were prenatally exposed to an mRNA vaccine compared to liveborn infants born to 7591 unvaccinated pregnant women in a large cohort study in Israel (Goldshtein et al., 2022). In other population-based studies conducted in Canada, Israel, Malaysia, Sweden, Norway, and the United Kingdom, vaccination against SARS-CoV-2 during pregnancy was not significantly associated with an increased risk of adverse pregnancy and neonatal outcomes, including stillbirth, small for gestational age, preterm delivery, low Apgar scores, or NICU admission, compared to the outcome of unvaccinated pregnant women (Arulappen et al., 2022; Blakeway et al., 2022; Fell et al., 2022; Magnus et al., 2022; Sadarangani et al., 2022; Kugelman et al., 2023). Most of the vaccinations in those studies were mRNA COVID-19 vaccines and were given during the second and third trimesters of pregnancy.
Three cohort studies from Mexico, Australia, and the United States reported significantly reduced incidences of stillbirth and preterm birth among a total of more than 46,226 vaccinated pregnant women with an mRNA vaccine compared to unvaccinated women (Piekos et al., 2022; Hui et al., 2023; Morgan et al., 2023).
TRANSPLACENTAL PASSAGE OF SARS-CoV-2 ANTIBODIES
Several studies reported SARS-CoV-2 IgG antibodies being detectable in the cord blood of infants whose mothers were vaccinated with an mRNA vaccine in the second half of pregnancy (Gray et al., 2021; Mithal et al., 2021; Rottenstreich et al., 2021; Kassis et al., 2022; Shook et al., 2022). Evidence of transplacental passage following vaccination in early pregnancy has also been demonstrated in some other reports (Atyeo et al., 2022; Rottenstreich et al., 2022; Sourouni et al., 2022).
ANIMAL TERATOLOGY STUDIES
No teratogenic or other adverse fetal effects were observed among the offspring of mice and rats injected with mRNA-1273 vaccine during early pregnancy with 50-300 times greater doses than those used in humans (Bowman et al., 2021; Lu-Culligan et al., 2022). In both studies, pregnant dams vaccinated prior to placental establishment and fetal circulation conferred fetal transfer of antibodies up to the time of birth.
References:
(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].)
Aharon D, Lederman M, Ghofranian A, Hernandez-Nieto C, Canon C, Hanley W, Gounko D, Lee JA, Stein D, Buyuk E, Copperman AB: In vitro fertilization and early pregnancy outcomes after coronavirus disease 2019 (COVID-19) vaccination. Obstet Gynecol 139(4):490-497, 2022. [E]
Arulappen AL, Danial M, Shanmugam G, Cheng JT, Dulasi M, Chow TS: A multicenter cohort study on the adverse effects evaluation after messenger RNA COVID-19 vaccination among pregnant healthcare employees in Penang general hospitals. Front Public Health 10:876966, 2022. [E]
Atyeo CG, Shook LL, Brigida S, De Guzman RM, Demidkin S, Muir C, Akinwunmi B, Baez AM, Sheehan ML, McSweeney E, Burns MD, Nayak R, Kumar MK, Patel CD, Fialkowski A, Cvrk D, Goldfarb IT, Yonker LM, Fasano A, Balazs AB, Elovitz MA, Gray KJ, Alter G, Edlow AG: Maternal immune response and placental antibody transfer after COVID-19 vaccination across trimester and platforms. Nat Commun 13(1):3571, 2022. [E]
Blakeway H, Prasad S, Kalafat E, Heath PT, Ladhani SN, Le Doare K, Magee LA, O'Brien P, Rezvani A, von Dadelszen P, Khalil A: COVID-19 vaccination during pregnancy: coverage and safety. Am J Obstet Gynecol 226(2):236.e1-236.e14, 2022. [E]
Bowman CJ, Bouressam M, Campion SN, Cappon GD, Catlin NR, Cutler MW, Diekmann J, Rohde CM, Sellers RS, Lindemann C. Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine. Reprod Toxicol 103:28-35, 2021. [A]
Calvert C, Carruthers J, Denny C, Donaghy J, Hillman S, Hopcroft LEM, Hopkins L, Goulding A, Lindsay L, McLaughlin T, Moore E, Pan J, Taylor B, Almaghrabi F, Auyeung B, Bhaskaran K, Gibbons CL, Katikireddi SV, McCowan C, Murray J, O'Leary M, Ritchie LD, Shah SA, Simpson CR, Robertson C, Sheikh A, Stock SJ, Wood R: A population-based matched cohort study of early pregnancy outcomes following COVID-19 vaccination and SARS-CoV-2 infection. Nat Commun 13(1):6124, 2022. [E]
Calvert C, Carruthers J, Denny C, Donaghy J, Hopcroft LEM, Hopkins L, Goulding A, Lindsay L, McLaughlin T, Moore E, Taylor B, Loane M, Dolk H, Morris J, Auyeung B, Bhaskaran K, Gibbons CL, Katikireddi SV, O'Leary M, McAllister D, Shi T, Simpson CR, Robertson C, Sheikh A, Stock SJ, Wood R: A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection. Nat Commun 14(1):107, 2023. [E]
Carbone L, Trinchillo MG, Di Girolamo R, Raffone A, Saccone G, Iorio GG, Gabrielli O, Maruotti GM: COVID-19 vaccine and pregnancy outcomes: a systematic review and meta-analysis. Int J Gynaecol Obstet 159(3):651-661, 2022. [R]
Citu IM, Citu C, Gorun F, Sas I, Bratosin F, Motoc A, Burlea B, Rosca O, Malita D, Gorun OM: The risk of spontaneous abortion does not increase following first trimester mRNA COVID-19 vaccination. J Clin Med 11(6):1698, 2022. [E]
Ding C, Liu Y, Pang W, Zhang D, Wang K, Chen Y: Associations of COVID-19 vaccination during pregnancy with adverse neonatal and maternal outcomes: a systematic review and meta-analysis. Front Public Health 11:1044031, 2023. [R]
Fell DB, Dhinsa T, Alton GD, Torok E, Dimanlig-Cruz S, Regan AK, Sprague AE, Buchan SA, Kwong JC, Wilson SE, Haberg SE, Gravel CA, Wilson K, El-Chaar D, Walker MC, Barrett J, MacDonald SE, Okun N, Shah PS, Dougan SD, Dunn S, Bisnaire L: Association of COVID-19 vaccination in pregnancy with adverse peripartum outcomes. JAMA 327(15):1478-1487, 2022. [E]
Goldshtein I, Steinberg DM, Kuint J, Chodick G, Segal Y, Shapiro Ben David S, Ben-Tov A: Association of BNT162b2 COVID-19 vaccination during pregnancy with neonatal and early infant outcomes. JAMA Pediatr 176(5):470-477, 2022. [E]
Gray KJ, Bordt EA, Atyeo C, Deriso E, Akinwunmi B, Young N, Baez AM, Shook LL, Cvrk D, James K, De Guzman R, Brigida S, Diouf K, Goldfarb I, Bebell LM, Yonker LM, Fasano A, Rabi SA, Elovitz MA, Alter G, Edlow AG: Coronavirus disease 2019 vaccine response in pregnant and lactating women: a cohort study. Am J Obstet Gynecol 225(3):303.e1-303.e17, 2021. [E]
Hui L, Marzan MB, Rolnik DL, Potenza S, Pritchard N, Said JM, Palmer KR, Whitehead CL, Sheehan PM, Ford J, Mol BW, Walker SP: Reductions in stillbirths and preterm birth in COVID-19 vaccinated women: a multi-center cohort study of vaccination uptake and perinatal outcomes. Am J Obstet Gynecol 228(5):585.e1-585.e16, 2023. [E]
Kassis NE, Abdallah W, Chakra RA, Arab W, Sassine S, Atallah D: COVID-19 mRNA vaccine in pregnancy and newborn passive immunization: a case report. Future Sci OA 8(1):FSO761, 2022. [C]
Kharbanda EO, Haapala J, Lipkind HS, DeSilva MB, Zhu J, Vesco KK, Daley MF, Donahue JG, Getahun D, Hambidge SJ, Irving SA, Klein NP, Nelson JC, Weintraub ES, Williams JTB, Vazquez-Benitez G: COVID-19 booster vaccination in early pregnancy and surveillance for spontaneous abortion. JAMA Netw Open 6(5):e2314350, 2023. [E]
Kugelman N, Riskin A, Kedar R, Riskin-Mashiah S: Safety of COVID-19 vaccination in pregnant women: a study of the adverse perinatal outcomes. Int J Gynaecol Obstet 161(1):298-302, 2023. [E]
Lu-Culligan A, Tabachnikova A, Perez-Then E, Tokuyama M, Lee HJ, Lucas C, Silva Monteiro V, Miric M, Brache V, Cochon L, Muenker MC, Mohanty S, Huang J, Kang I, Dela Cruz C, Farhadian S, Campbell M, Yildirim I, Shaw AC, Ma S, Vermund SH, Ko AI, Omer SB, Iwasaki A: No evidence of fetal defects or anti-syncytin-1 antibody induction following COVID-19 mRNA vaccination. PLoS Biol 20(5):e3001506, 2022. [A]
Ma Y, Deng J, Liu Q, Du M, Liu M, Liu J: Effectiveness and safety of COVID-19 vaccine among pregnant women in real-world studies: a systematic review and meta-analysis. Vaccines 10(2):246, 2022. [R]
Magnus MC, Gjessing HK, Eide HN, Wilcox AJ, Fell DB, Haberg SE: Covid-19 vaccination during pregnancy and first-trimester miscarriage. N Engl J Med 385(21):2008-2010, 2021. [E]
Magnus MC, Ortqvist AK, Dahlqwist E, Ljung R, Skar F, Oakley L, Macsali F, Pasternak B, Gjessing HK, Haberg SE, Stephansson O: Association of SARS-CoV-2 vaccination during pregnancy with pregnancy outcomes. JAMA 327(15):1469-1477, 2022. [E]
Mansour O, Hernandez-Diaz S, Wyszynski DF: mRNA COVID-19 vaccination early in pregnancy and the risk of spontaneous abortion in an international pregnancy registry. Pharmacoepidemiol Drug Saf 32(6):685-693, 2023. [E]
Mascolo A, di Mauro G, Fraenza F, Gaio M, Zinzi A, Pentella C, Rossi F, Capuano A, Sportiello L: Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: the preg-co-vax study. Front Immunol 13:965171, 2022. [E]
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 225(2):192-194, 2021. [S]
Morgan JA, Biggio JR Jr, Martin JK, Mussarat N, Elmayan A, Chawla HK, Kandalaft S, Magalski GR, Puri P, Williams FB: Pregnancy outcomes in patients after completion of the mRNA coronavirus disease 2019 (COVID-19) vaccination series compared with unvaccinated patients. Obstet Gynecol 141(3):555-562, 2023. [E]
Piekos SN, Hwang YM, Roper RT, Sorensen T, Price ND, Hood L, Hadlock JJ. The effect of COVID-19 vaccination and booster on maternal-fetal outcomes: a retrospective multicenter cohort study (Preprint). medRxiv 2022 Aug 18. DOI: 10.1101/2022.08.12.22278727 (accessed December 2022). [E]
Prasad S, Kalafat E, Blakeway H, Townsend R, O'Brien P, Morris E, Draycott T, Thangaratinam S, Le Doare K, Ladhani S, von Dadelszen P, Magee LA, Heath P, Khalil A: Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy. Nat Commun 13(1):2414, 2022. [R]
Rottenstreich A, Zarbiv G, Oiknine-Djian E, Vorontsov O, Zigron R, Kleinstern G, Wolf DG, Porat S: The effect of gestational age at BNT162b2 mRNA vaccination on maternal and neonatal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody levels. Clin Infect Dis 75(1):e603-e610, 2022. [S]
Rottenstreich A, Zarbiv G, Oiknine-Djian E, Zigron R, Wolf DG, Porat S: Efficient maternofetal transplacental transfer of anti- SARS-CoV-2 spike antibodies after antenatal SARS-CoV-2 BNT162b2 mRNA vaccination. Clin Infect Dis 73(10):1909-1912, 2021. [S]
Ruderman RS, Mormol J, Trawick E, Perry MF, Allen EC, Millan D, Miller ES: Association of COVID-19 Vaccination During early pregnancy with risk of congenital fetal anomalies. JAMA Pediatr 176(7):717-719, 2022. [E]
Sadarangani M, Soe P, Shulha HP, Valiquette L, Vanderkooi OG, Kellner JD, Muller MP, Top KA, Isenor JE, McGeer A, Irvine M, De Serres G, Marty K, Bettinger JA: Safety of COVID-19 vaccines in pregnancy: a Canadian National Vaccine Safety (CANVAS) network cohort study. Lancet Infect Dis 22(11):1553-1564, 2022. [E]
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 384(24):2273-2282, 2021. [E]
Shook LL, Atyeo CG, Yonker LM, Fasano A, Gray KJ, Alter G, Edlow AG: Durability of anti-spike antibodies in infants after maternal COVID-19 vaccination or natural infection. JAMA 327(11):1087-1089. 2022. [E]
Sourouni M, Braun J, Oelmeier K, Mollers M, Willy D, Hennies MT, Koster HA, Pecks U, Klockenbusch W, Schmitz R: Assessment of neonatal cord blood SARS-CoV-2 antibodies after COVID-19 vaccination in pregnancy: a prospective cohort study. Geburtshilfe Frauenheilkd 82(5):510-516, 2022. [S]
Tormen M, Taliento C, Salvioli S, Piccolotti I, Scutiero G, Cappadona R, Greco P: Effectiveness and safety of COVID-19 vaccine in pregnant women: a systematic review with meta-analysis. BJOG 130(4):348-357, 2023. [R]
Trostle ME, Limaye MA, Avtushka V, Lighter JL, Penfield CA, Roman AS: COVID-19 vaccination in pregnancy: early experience from a single institution. Am J Obstet Gynecol MFM 3(6):100464, 2021. [E]
Vazquez-Benitez G, Haapala JL, Lipkind HS, DeSilva MB, Zhu J, Daley MF, Getahun D, Klein NP, Vesco KK, Irving SA, Nelson JC, Williams JTB, Hambidge SJ, Donahue J, Fuller CC, Weintraub ES, Olson C, Kharbanda EO: COVID-19 vaccine safety surveillance in early pregnancy in the United States: design factors affecting the association between vaccine and spontaneous abortion. Am J Epidemiol 2023 Mar 16 (published online ahead of print). [E]
Watanabe A, Yasuhara J, Iwagami M, Miyamoto Y, Yamada Y, Suzuki Y, Takagi H, Kuno T: Peripartum outcomes associated with COVID-19 vaccination during pregnancy: a systematic review and meta-analysis [published erratum appears in JAMA Pediatr 176(11):1154, 2022]. JAMA Pediatr 176(11):1098-1106, 2022. [R]
Zauche LH, Wallace B, Smoots AN, Olson CK, Oduyebo T, Kim SY, Petersen EE, Ju J, Beauregard J, Wilcox AJ, Rose CE, Meaney-Delman DM, Ellington SR; CDC v-safe Covid-19 Pregnancy Registry Team: Receipt of mRNA Covid-19 vaccines and risk of spontaneous abortion. N Engl J Med 385(16):1533-1535, 2021. [E]
Zhang D, Huang T, Chen Z, Zhang L, Gao Q, Liu G, Zheng J, Ding F: Systematic review and meta-analysis of neonatal outcomes of COVID-19 vaccination in pregnancy. Pediatr Res 2023 Jan 3 (published online ahead of print). [R]
Arulappen AL, Danial M, Shanmugam G, Cheng JT, Dulasi M, Chow TS: A multicenter cohort study on the adverse effects evaluation after messenger RNA COVID-19 vaccination among pregnant healthcare employees in Penang general hospitals. Front Public Health 10:876966, 2022. [E]
Atyeo CG, Shook LL, Brigida S, De Guzman RM, Demidkin S, Muir C, Akinwunmi B, Baez AM, Sheehan ML, McSweeney E, Burns MD, Nayak R, Kumar MK, Patel CD, Fialkowski A, Cvrk D, Goldfarb IT, Yonker LM, Fasano A, Balazs AB, Elovitz MA, Gray KJ, Alter G, Edlow AG: Maternal immune response and placental antibody transfer after COVID-19 vaccination across trimester and platforms. Nat Commun 13(1):3571, 2022. [E]
Blakeway H, Prasad S, Kalafat E, Heath PT, Ladhani SN, Le Doare K, Magee LA, O'Brien P, Rezvani A, von Dadelszen P, Khalil A: COVID-19 vaccination during pregnancy: coverage and safety. Am J Obstet Gynecol 226(2):236.e1-236.e14, 2022. [E]
Bowman CJ, Bouressam M, Campion SN, Cappon GD, Catlin NR, Cutler MW, Diekmann J, Rohde CM, Sellers RS, Lindemann C. Lack of effects on female fertility and prenatal and postnatal offspring development in rats with BNT162b2, a mRNA-based COVID-19 vaccine. Reprod Toxicol 103:28-35, 2021. [A]
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COVID-19 VACCINE PREGNANCY REGISTRIES
Healthcare providers are encouraged to suggest their patients enroll in the following registries:
COVID-19 Vaccine Study
An observational pregnancy study by MotherToBaby has been established for women who received one or more doses of a COVID-19 vaccine during pregnancy or within one month prior to becoming pregnant. All study research will be performed via phone and office visits will not be required.
Additional information about the study can be found at MotherToBaby’s COVID-19 Vaccines (https://mothertobaby.org/ongoing-study/covid19-vaccines/). Healthcare providers are encouraged to enroll such patients at https://mothertobaby.org/join-a-study-form/.
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 at: https://www.clinicaltrials.gov/ct2/show/NCT04705116.
CANADIAN COVID-19 VACCINE REGISTRY FOR PREGNANT AND LACTATING INDIVIDUALS
A registry collecting information from women who are currently pregnant or breastfeeding regardless of vaccination status is maintained by the University of British Columbia in Vancouver, B.C., CANADA and in partnership with other Canadian vaccine surveillance networks. The registry is a longitudinal survey monitoring the safety, effectiveness, and opinions related to the COVID-19 vaccine.
Healthcare providers may find more information about this registry at: https://covered.med.ubc.ca/.
Healthcare providers are encouraged to suggest their patients enroll in the following registries:
COVID-19 Vaccine Study
An observational pregnancy study by MotherToBaby has been established for women who received one or more doses of a COVID-19 vaccine during pregnancy or within one month prior to becoming pregnant. All study research will be performed via phone and office visits will not be required.
Additional information about the study can be found at MotherToBaby’s COVID-19 Vaccines (https://mothertobaby.org/ongoing-study/covid19-vaccines/). Healthcare providers are encouraged to enroll such patients at https://mothertobaby.org/join-a-study-form/.
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 at: https://www.clinicaltrials.gov/ct2/show/NCT04705116.
CANADIAN COVID-19 VACCINE REGISTRY FOR PREGNANT AND LACTATING INDIVIDUALS
A registry collecting information from women who are currently pregnant or breastfeeding regardless of vaccination status is maintained by the University of British Columbia in Vancouver, B.C., CANADA and in partnership with other Canadian vaccine surveillance networks. The registry is a longitudinal survey monitoring the safety, effectiveness, and opinions related to the COVID-19 vaccine.
Healthcare providers may find more information about this registry at: https://covered.med.ubc.ca/.
Agent Metadata
| TERIS Agent Number: | 6816 |
| Bibliographic Search Date: | 05/2023 |