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Article ; Online: mRNA Covid-19 Vaccines in Pregnant Women.

Riley, Laura E

2021 Volume 384, Issue 24, Page(s) 2342–2343

MeSH term(s)	COVID-19 ; COVID-19 Vaccines ; Female ; Humans ; Pregnancy ; Pregnancy Complications, Infectious/prevention & control ; Pregnant Women ; RNA, Messenger ; SARS-CoV-2
Chemical Substances	COVID-19 Vaccines ; RNA, Messenger
Language	English
Publishing date	2021-07-12
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMe2107070
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Article ; Online: mRNA Covid-19 Vaccines in Pregnant Women.

The New England journal of medicine

2021 Volume 385, Issue 16, Page(s) 1536

Language	English
Publishing date	2021-09-08
Publishing country	United States
Document type	Published Erratum
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMx210017
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Article ; Online: Immunogenicity of COVID-19 mRNA Vaccines in Pregnant and Lactating Women.

Collier, Ai-Ris Y / McMahan, Katherine / Yu, Jingyou / Tostanoski, Lisa H / Aguayo, Ricardo / Ansel, Jessica / Chandrashekar, Abishek / Patel, Shivani / Apraku Bondzie, Esther / Sellers, Daniel / Barrett, Julia / Sanborn, Owen / Wan, Huahua / Chang, Aiquan / Anioke, Tochi / Nkolola, Joseph / Bradshaw, Connor / Jacob-Dolan, Catherine / Feldman, Jared /

Gebre, Makda / Borducchi, Erica N / Liu, Jinyan / Schmidt, Aaron G / Suscovich, Todd / Linde, Caitlyn / Alter, Galit / Hacker, Michele R / Barouch, Dan H

JAMA

2021 Volume 325, Issue 23, Page(s) 2370–2380

Abstract: ... women who received either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines and 22 ... of a COVID-19 mRNA vaccine was immunogenic in pregnant women, and vaccine-elicited antibodies were ... mRNA) vaccines in pregnant and lactating women, including against emerging SARS-CoV-2 variants ...

Abstract	Importance: Pregnant women are at increased risk of morbidity and mortality from COVID-19 but have been excluded from the phase 3 COVID-19 vaccine trials. Data on vaccine safety and immunogenicity in these populations are therefore limited. Objective: To evaluate the immunogenicity of COVID-19 messenger RNA (mRNA) vaccines in pregnant and lactating women, including against emerging SARS-CoV-2 variants of concern. Design, setting, and participants: An exploratory, descriptive, prospective cohort study enrolled 103 women who received a COVID-19 vaccine from December 2020 through March 2021 and 28 women who had confirmed SARS-CoV-2 infection from April 2020 through March 2021 (the last follow-up date was March 26, 2021). This study enrolled 30 pregnant, 16 lactating, and 57 neither pregnant nor lactating women who received either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines and 22 pregnant and 6 nonpregnant unvaccinated women with SARS-CoV-2 infection. Main outcomes and measures: SARS-CoV-2 receptor binding domain binding, neutralizing, and functional nonneutralizing antibody responses from pregnant, lactating, and nonpregnant women were assessed following vaccination. Spike-specific T-cell responses were evaluated using IFN-γ enzyme-linked immunospot and multiparameter intracellular cytokine-staining assays. Humoral and cellular immune responses were determined against the original SARS-CoV-2 USA-WA1/2020 strain as well as against the B.1.1.7 and B.1.351 variants. Results: This study enrolled 103 women aged 18 to 45 years (66% non-Hispanic White) who received a COVID-19 mRNA vaccine. After the second vaccine dose, fever was reported in 4 pregnant women (14%; SD, 6%), 7 lactating women (44%; SD, 12%), and 27 nonpregnant women (52%; SD, 7%). Binding, neutralizing, and functional nonneutralizing antibody responses as well as CD4 and CD8 T-cell responses were present in pregnant, lactating, and nonpregnant women following vaccination. Binding and neutralizing antibodies were also observed in infant cord blood and breast milk. Binding and neutralizing antibody titers against the SARS-CoV-2 B.1.1.7 and B.1.351 variants of concern were reduced, but T-cell responses were preserved against viral variants. Conclusion and relevance: In this exploratory analysis of a convenience sample, receipt of a COVID-19 mRNA vaccine was immunogenic in pregnant women, and vaccine-elicited antibodies were transported to infant cord blood and breast milk. Pregnant and nonpregnant women who were vaccinated developed cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants of concern.
MeSH term(s)	2019-nCoV Vaccine mRNA-1273 ; Adult ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; BNT162 Vaccine ; COVID-19/immunology ; COVID-19 Vaccines/immunology ; Cross Reactions/immunology ; Female ; Fetal Blood/immunology ; Humans ; Immunoassay ; Immunogenicity, Vaccine ; Lactation ; Leukocytes, Mononuclear/physiology ; Middle Aged ; Milk, Human/immunology ; Pregnancy/immunology ; Prospective Studies ; SARS-CoV-2/immunology ; T-Lymphocytes/immunology ; Vaccines, Synthetic/immunology ; Young Adult ; mRNA Vaccines
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines ; Vaccines, Synthetic ; 2019-nCoV Vaccine mRNA-1273 (EPK39PL4R4) ; BNT162 Vaccine (N38TVC63NU)
Language	English
Publishing date	2021-04-23
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2021.7563
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Article ; Online: Systematic Review: Safety and Efficacy of mRNA COVID-19 Vaccines in Pregnant Women.

Lam, Julie Ngoc / Nehira, Jeffrey / Phung, Olivia / Deng, Bin

Journal of pharmacy practice

2023 , Page(s) 8971900231196065

Abstract: ... and safety of mRNA COVID-19 vaccines in pregnant women. A total of five studies including 42,782 women ... in this population. This systematic review explored the safety and efficacy of mRNA vaccines in pregnant women ... were included in the systematic review. Humoral immunity to COVID-19 was detected in pregnant women ...

Abstract	Since pregnant women were excluded from clinical trials for vaccines against SARS-CoV-2, the novel coronavirus disease 2019 (COVID-19), there is limited data on the safety and efficacy of vaccines in this population. This systematic review explored the safety and efficacy of mRNA vaccines in pregnant women. A literature search was performed using Ovid databases through November 2021 for all studies evaluated efficacy and safety of mRNA COVID-19 vaccines in pregnant women. A total of five studies including 42,782 women were included in the systematic review. Humoral immunity to COVID-19 was detected in pregnant women who received the vaccine and no differences found in spike-specific T-cell responses. Incidence of high-grade chronic villitis is higher in the unvaccinated group with adjusted odds ratio of .31 (.1-.97),
Language	English
Publishing date	2023-08-22
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1027474-1
ISSN	1531-1937 ; 0897-1900
ISSN (online)	1531-1937
ISSN	0897-1900
DOI	10.1177/08971900231196065
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Article ; Online: Effects of SARS-Cov-2 mRNA vaccine on placental histopathology: Comparison of a population of uncomplicated COVID-19 positive pregnant women.

Tartaglia, Silvio / Di Ilio, Chiara / Romanzi, Federica / Moresi, Sascia / Nardi, Eleonora / Bevilacqua, Elisa / Arena, Vincenzo / Lanzone, Antonio

Placenta

2024 Volume 149, Page(s) 64–71

Abstract: ... COVID-19-positive women were admitted for delivery. Of these, 98 with non-severe symptoms were analyzed ... on placental tissue in COVID-19-infected pregnant patients. Notably, no side effects were reported post ... histopathology in pregnant women, comparing outcomes between vaccinated and non-vaccinated individuals. Despite ...

Abstract	1. Introduction: This study investigates the impact of SARS-CoV-2 infection on placental histopathology in pregnant women, comparing outcomes between vaccinated and non-vaccinated individuals. Despite known adverse pregnancy outcomes linked to SARS-CoV-2 infection, the specific effects on the placenta remain unclear. Although vaccination has demonstrated a substantial reduction in infection severity, its impact on placental health requires more insight. 2. Methods: Between March 2021 and July 2022, 387 COVID-19-positive women were admitted for delivery. Of these, 98 with non-severe symptoms were analyzed: 35 vaccinated during pregnancy, and 63 non-vaccinated. Two independent pathologists evaluated all placental specimens. 3. Results: The only differing obstetrical characteristic between groups was the mode of delivery (p 0.047), lacking clinical implications. Over 85% of placentas exhibited microscopic abnormalities, predominantly maternal vascular supply disorders (vaccinated 89.1%; unvaccinated 85.5%). Comparing vaccinated and unvaccinated groups revealed statistically significant differences, notably in increased focal perivillous fibrin deposits (IFPFD) [17.1% vs. 33.3% (p 0.04)] and avascular fibrotic villi (AFV) [0% vs. 11.1% (p 0.04)]. Binomial logistic regression confirmed the vaccine's protective role against IFPFD (aOR 0.36; 95%CI 013-0.99) and AVF (aOR 0.06, 95% CI 0.003-0.98). A sub-analysis in vaccinated women showed a positive correlation between the timing of the first dose and IFPFD presence (p 0.018). 4. Discussion: The lower incidence of maternal and fetal vascular malperfusion placental features in vaccinated women, coupled with the timing correlation, supports the vaccine's protective effect on placental tissue in COVID-19-infected pregnant patients. Notably, no side effects were reported post-vaccination, emphasizing the vaccine's safety and advocating for its secure administration in pregnant populations.
MeSH term(s)	Pregnancy ; Humans ; Female ; COVID-19 Vaccines ; COVID-19/prevention & control ; mRNA Vaccines ; SARS-CoV-2 ; Pregnant Women ; Placenta ; Pregnancy Complications, Infectious/prevention & control
Chemical Substances	COVID-19 Vaccines ; mRNA Vaccines
Language	English
Publishing date	2024-03-14
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	603951-0
ISSN	1532-3102 ; 0143-4004
ISSN (online)	1532-3102
ISSN	0143-4004
DOI	10.1016/j.placenta.2024.03.008
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Article: COVID-19 mRNA vaccines drive differential Fc-functional profiles in pregnant, lactating, and non-pregnant women.

Atyeo, Caroline / DeRiso, Elizabeth A / Davis, Christine / Bordt, Evan A / DeGuzman, Rose M / Shook, Lydia L / Yonker, Lael M / Fasano, Alessio / Akinwunmi, Babatunde / Lauffenburger, Douglas A / Elovitz, Michal A / Gray, Kathryn J / Edlow, Andrea G / Alter, Galit

bioRxiv : the preprint server for biology

2021

Abstract: ... more severe COVID-19 disease. Whether these changes also make pregnant women less responsive ... the humoral vaccine response in a group of pregnant and lactating women and non-pregnant age-matched controls ... Vaccine-specific titers were comparable, albeit slightly lower, between pregnant and lactating women ...

Abstract	Significant immunological changes occur throughout pregnancy to tolerize the mother and allow growth of the fetal graft. However, additional local and systemic immunological adaptations also occur, allowing the maternal immune system to continue to protect the dyad against foreign invaders both during pregnancy and after birth through lactation. This fine balance of tolerance and immunity, along with physiological and hormonal changes, contribute to increased susceptibility to particular infections in pregnancy, including more severe COVID-19 disease. Whether these changes also make pregnant women less responsive to vaccination or induce altered immune responses to vaccination remains incompletely understood. To holistically define potential changes in vaccine response during pregnancy and lactation, we deeply profiled the humoral vaccine response in a group of pregnant and lactating women and non-pregnant age-matched controls. Vaccine-specific titers were comparable, albeit slightly lower, between pregnant and lactating women, compared to non-pregnant controls. Among pregnant women, we found higher antibody titers and functions in those vaccinated with the Moderna vaccine. FcR-binding and antibody effector functions were induced with delayed kinetics in both pregnant and lactating women compared to non-pregnant women. Antibody boosting resulted in high FcR-binding titers in breastmilk. These data point to an immune resistance to generate highly inflammatory antibodies during pregnancy and lactation, and a critical need to follow prime/boost timelines in this vulnerable population to ensure full immunity is attained.
Language	English
Publishing date	2021-04-05
Publishing country	United States
Document type	Preprint
DOI	10.1101/2021.04.04.438404
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Article ; Online: COVID-19 mRNA vaccines drive differential antibody Fc-functional profiles in pregnant, lactating, and nonpregnant women.

Atyeo, Caroline / DeRiso, Elizabeth A / Davis, Christine / Bordt, Evan A / De Guzman, Rose M / Shook, Lydia L / Yonker, Lael M / Fasano, Alessio / Akinwunmi, Babatunde / Lauffenburger, Douglas A / Elovitz, Michal A / Gray, Kathryn J / Edlow, Andrea G / Alter, Galit

Science translational medicine

2021 Volume 13, Issue 617, Page(s) eabi8631

Abstract: ... we undertook deep sequencing of the humoral vaccine response in a group of pregnant and lactating women and ... induced with delayed kinetics in both pregnant and lactating women compared with nonpregnant women after ... nonpregnant age-matched controls. Vaccine-specific titers were comparable between pregnant women, lactating ...

Abstract	Substantial immunological changes occur throughout pregnancy to render the mother immunologically tolerant to the fetus and allow fetal growth. However, additional local and systemic immunological adaptations also occur, allowing the maternal immune system to continue to protect the dyad against pathogens both during pregnancy and after birth through lactation. This fine balance of tolerance and immunity, along with physiological and hormonal changes, contributes to increased susceptibility to particular infections in pregnancy, including more severe coronavirus disease 2019 (COVID-19). Whether these changes also make pregnant women less responsive to vaccination or induce altered immune responses to vaccination remains incompletely understood. To define potential changes in vaccine response during pregnancy and lactation, we undertook deep sequencing of the humoral vaccine response in a group of pregnant and lactating women and nonpregnant age-matched controls. Vaccine-specific titers were comparable between pregnant women, lactating women, and nonpregnant controls. However, Fc receptor (FcR) binding and antibody effector functions were induced with delayed kinetics in both pregnant and lactating women compared with nonpregnant women after the first vaccine dose, which normalized after the second dose. Vaccine boosting resulted in high FcR-binding titers in breastmilk. These data suggest that pregnancy promotes resistance to generating proinflammatory antibodies and indicates that there is a critical need to follow prime-boost timelines in this vulnerable population to ensure full immunity is attained.
MeSH term(s)	COVID-19 ; COVID-19 Vaccines ; Female ; Humans ; Lactation ; Pregnancy ; RNA, Messenger ; SARS-CoV-2
Chemical Substances	COVID-19 Vaccines ; RNA, Messenger
Language	English
Publishing date	2021-10-27
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2518854-9
ISSN	1946-6242 ; 1946-6234
ISSN (online)	1946-6242
ISSN	1946-6234
DOI	10.1126/scitranslmed.abi8631
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Article ; Online: COVID-19 mRNA vaccination status and concerns among pregnant women in Japan: a multicenter questionnaire survey.

Takahashi, Ken / Samura, Osamu / Hasegawa, Akihiro / Okubo, Haruna / Morimoto, Keiji / Horiya, Madoka / Okamoto, Aikou / Ochiai, Daigo / Tanaka, Mamoru / Sekiguchi, Masaki / Miyasaka, Naoyuki / Suzuki, Yuto / Tabata, Tsutomu / Hayata, Eijiro / Nakata, Masahiko / Suzuki, Tomoo / Nishi, Hirotaka / Toda, Yumi / Tanigaki, Shinji /

Furuya, Natsumi / Hasegawa, Junichi / Tamaru, Shunsuke / Kamei, Yoshimasa / Sayama, Seisuke / Nagamatsu, Takeshi / Takahashi, Yuka Otera / Kitagawa, Michihiro / Arakaki, Tatsuya / Sekizawa, Akihiko

BMC pregnancy and childbirth

2023 Volume 23, Issue 1, Page(s) 332

Abstract: ... the main reasons that prevented pregnant women from being vaccinated. To resolve concerns, it is necessary ... into vaccinated and unvaccinated groups. Perinatal outcomes, COVID-19 prevalence, and disease severity were ... demonstrated low COVID-19 morbidity and severity. In the vaccinated group, the preterm birth rate ...

Abstract	Background: mRNA vaccination is an effective, safe, and widespread strategy for protecting pregnant women against infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, information on factors such as perinatal outcomes, safety, and coverage of mRNA vaccinations among pregnant women is limited in Japan. Therefore, this study aimed to investigate the perinatal outcomes, coverage, adverse effects, and short-term safety of mRNA vaccination as well as vaccine hesitancy among pregnant women. Methods: We conducted a multicenter online survey of postpartum women who delivered their offspring at 15 institutions around Tokyo from October 2021 to March 2022. Postpartum women were divided into vaccinated and unvaccinated groups. Perinatal outcomes, COVID-19 prevalence, and disease severity were compared between the two groups. Adverse reactions in the vaccinated group and the reasons for being unvaccinated were also investigated retrospectively. Results: A total of 1,051 eligible postpartum women were included. Of these, 834 (79.4%) had received an mRNA vaccine, while 217 (20.6%) had not, mainly due to concerns about the effect of vaccination on the fetus. Vaccination did not increase the incidence of adverse perinatal outcomes, including fetal morphological abnormalities. The vaccinated group demonstrated low COVID-19 morbidity and severity. In the vaccinated group, the preterm birth rate, cesarean section rate, and COVID-19 incidence were 7.2%, 33.2%, and 3.3%, respectively, compared with the 13.7%, 42.2%, and 7.8% in the unvaccinated group, respectively. Almost no serious adverse reactions were associated with vaccination. Conclusions: mRNA vaccines did not demonstrate any adverse effects pertaining to short-term perinatal outcomes and might have prevented SARS-CoV-2 infection or reduced COVID-19 severity. Concerns regarding the safety of the vaccine in relation to the fetus and the mother were the main reasons that prevented pregnant women from being vaccinated. To resolve concerns, it is necessary to conduct further research to confirm not only the short-term safety but also the long-term safety of mRNA vaccines.
MeSH term(s)	Infant, Newborn ; Pregnancy ; Female ; Humans ; Japan/epidemiology ; Pregnant Women ; Cesarean Section ; Retrospective Studies ; COVID-19/epidemiology ; COVID-19/prevention & control ; SARS-CoV-2 ; Premature Birth/epidemiology ; Vaccination/adverse effects ; Drug-Related Side Effects and Adverse Reactions ; Surveys and Questionnaires
Language	English
Publishing date	2023-05-09
Publishing country	England
Document type	Multicenter Study ; Journal Article
ZDB-ID	2059869-5
ISSN	1471-2393 ; 1471-2393
ISSN (online)	1471-2393
ISSN	1471-2393
DOI	10.1186/s12884-023-05669-4
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Article ; Online: Corrigendum to "Effects of SARS-Cov-2 mRNA vaccine on placental histopathology: Comparison of a population of uncomplicated COVID-19 positive pregnant women" [Placenta 149 (2024) 64-71].

Tartaglia, Silvio / Di Ilio, Chiara / Romanzi, Federica / Moresi, Sascia / Nardi, Eleonora / Bevilacqua, Elisa / Arena, Vincenzo / Lanzone, Antonio

Placenta

2024 Volume 151, Page(s) 18

Language	English
Publishing date	2024-04-17
Publishing country	Netherlands
Document type	Published Erratum
ZDB-ID	603951-0
ISSN	1532-3102 ; 0143-4004
ISSN (online)	1532-3102
ISSN	0143-4004
DOI	10.1016/j.placenta.2024.04.004
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Article ; Online: COVID-19 mRNA vaccines drive differential Fc-functional profiles in pregnant, lactating, and non-pregnant women

Atyeo, Caroline / Deriso, Elizabeth A. / Davis, Christine / Bordt, Evan A / De Guzman, Rose M. / Shook, Lydia L. / Yonker, Lael M. / Fasano, Alessio / Akinwunmi, Babatunde / Lauffenburger, Douglas A / Elovitz, Michal A. / Gray, Kathryn J. / Edlow, Andrea G. / Alter, Galit J.

bioRxiv

Abstract	Significant immunological changes occur throughout pregnancy to tolerize the mother and allow growth of the fetal graft. However, additional local and systemic immunological adaptations also occur, allowing the maternal immune system to continue to protect the dyad against foreign invaders both during pregnancy and after birth through lactation. This fine balance of tolerance and immunity, along with physiological and hormonal changes, contribute to increased susceptibility to particular infections in pregnancy, including more severe COVID-19 disease. Whether these changes also make pregnant women less responsive to vaccination or induce altered immune responses to vaccination remains incompletely understood. To holistically define potential changes in vaccine response during pregnancy and lactation, we deeply profiled the humoral vaccine response in a group of pregnant and lactating women and non-pregnant age-matched controls. Vaccine-specific titers were comparable, albeit slightly lower, between pregnant and lactating women, compared to non-pregnant controls. Among pregnant women, we found higher antibody titers and functions in those vaccinated with the Moderna vaccine. FcR-binding and antibody effector functions were induced with delayed kinetics in both pregnant and lactating women compared to non-pregnant women. Antibody boosting resulted in high FcR-binding titers in breastmilk. These data point to an immune resistance to generate highly inflammatory antibodies during pregnancy and lactation, and a critical need to follow prime/boost timelines in this vulnerable population to ensure full immunity is attained.
Keywords	covid19
Language	English
Publishing date	2021-04-05
Publisher	Cold Spring Harbor Laboratory
Document type	Article ; Online
DOI	10.1101/2021.04.04.438404
Database	COVID19

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