Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis

Ciapponi, Agustín; Berrueta, Mabel; Parker, Edward P K; Bardach, Ariel; Mazzoni, Agustina; Anderson, Annaliesa S.; Argento, Fernando J.; Ballivian, Jamile; Bok, Karin; Comandé, Daniel; Goucher, Erin; Kampmann, Beate; Cairoli, Federico Rodríguez; María, Victoria Santa; Stergachis, Andy; Voss, Gérald; Xiong, Xu; Zamora, Natalia; Zaraa, Sabra; Buekens, Pierre

doi:10.1016/j.vaccine.2023.03.038

Cited by 26 publications

(11 citation statements)

References 142 publications

(207 reference statements)

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“…However, women vaccinated during pregnancy with mRNA CoVID-19 vaccine did not experience higher adverse pregnancy or neonatal outcomes in recent studies, suggesting a reasonable safety profile of lipid nanoparticles coating. 9 , 10 In the absence of human reproductive safety information, the Swiss summary of product characteristics states that pregnancy should be excluded before starting treatment with patisiran, and women of childbearing age should use effective contraception. In women planning a pregnancy, patisiran and vitamin A supplementation should be discontinued, and serum vitamin A levels should be monitored and been returned to normal before conception is attempted.…”

Section: Discussionmentioning

confidence: 99%

Patisiran exposure in early pregnancy: a case report

Loser,

Baumgartner,

Legardeur

et al. 2024

Ther Adv Neurol Disord

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We describe here the first case of exposure to patisiran treatment, a small interfering RNA molecule, during early pregnancy of a 36-year-old woman with symptomatic hereditary transthyretin-related amyloidosis. There were no major complications during pregnancy and delivery, except for a postpartum hemorrhage due to uterine atony. Vitamin A levels had to be closely monitored during pregnancy, and vitamin A substitution adapted accordingly. There was no sign of minor or major congenital abnormalities of the baby. One month after delivery, the patient showed slight clinical and electrophysiological signs of neuropathy progression due to patisiran treatment withdrawal. Patisiran infusions were resumed 3 months after delivery. Due to the unknown teratogenic potential of patisiran, the risk of neuropathy worsening associated with withholding treatment must of course be weighed against a potential teratogenic risk of treatment during pregnancy. Vitamin A levels need to be closely assessed, and substitution must be adapted accordingly, to avoid embryofetal adverse outcome due to vitamin A deficiency or toxicity.

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Section: Discussionmentioning

confidence: 99%

Patisiran exposure in early pregnancy: a case report

Loser,

Baumgartner,

Legardeur

et al. 2024

Ther Adv Neurol Disord

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“…The two pregnancy outcomes we included were (1) preterm birth and (2) stillbirth; these outcomes were chosen for various reasons, including content knowledge, the existing literature [ 8 , 9 , 21 , 22 ], biological plausibility [ 23 ], data availability [ 24 ], risk profiles of other vaccines [ 25 ], our confidence in outcome definition precision in EHR systems [ 26 ], and sufficient outcome counts to be powered to estimate associations. Pregnancy outcomes and maternal covariates were defined based on OMOP concept sets and ATLAS ( (accessed on 7 December 2023)), the graphical user interface for the OMOP common data model [ 24 ].…”

Section: Methodsmentioning

confidence: 99%

Pregnancy Outcomes among Pregnant Persons after COVID-19 Vaccination: Assessing Vaccine Safety in Retrospective Cohort Analysis of U.S. National COVID Cohort Collaborative (N3C)

Faherty,

Wilkins,

Jones

et al. 2024

Vaccines

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COVID-19 vaccines have been shown to be effective in preventing severe illness, including among pregnant persons. The vaccines appear to be safe in pregnancy, supporting a continuously favorable overall risk/benefit profile, though supportive data for the U.S. over different periods of variant predominance are lacking. We sought to analyze the association of adverse pregnancy outcomes with COVID-19 vaccinations in the pre-Delta, Delta, and Omicron SARS-CoV-2 variants’ dominant periods (constituting 50% or more of each pregnancy) for pregnant persons in a large, nationally sampled electronic health record repository in the U.S. Our overall analysis included 311,057 pregnant persons from December 2020 to October 2023 at a time when there were approximately 3.6 million births per year. We compared rates of preterm births and stillbirths among pregnant persons who were vaccinated before or during pregnancy to persons vaccinated after pregnancy or those who were not vaccinated. We performed a multivariable Poisson regression with generalized estimated equations to address data site heterogeneity for preterm births and unadjusted exact models for stillbirths, stratified by the dominant variant period. We found lower rates of preterm birth in the majority of modeled periods (adjusted incidence rate ratio [aIRR] range: 0.42 to 0.85; p-value range: <0.001 to 0.06) and lower rates of stillbirth (IRR range: 0.53 to 1.82; p-value range: <0.001 to 0.976) in most periods among those who were vaccinated before or during pregnancy compared to those who were vaccinated after pregnancy or not vaccinated. We largely found no adverse associations between COVID-19 vaccination and preterm birth or stillbirth; these findings reinforce the safety of COVID-19 vaccination during pregnancy and bolster confidence for pregnant persons, providers, and policymakers in the importance of COVID-19 vaccination for this group despite the end of the public health emergency.

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“…Given the high HIV burden in sub-Saharan African countries [18], as well as the risks of SARS-CoV-2 infection during pregnancy, it is critical to investigate immune responses to SARS-CoV-2 infection and associated variants in WLWH. Most studies have only compared humoral responses between pregnant and non-pregnant women following SARS-CoV-2 infection or Covid-19 vaccination [13,15,[19][20][21]. However, there is a paucity of information on SARS-CoV-2 cell-mediated immune responses in PWH from low-and middle-income settings [12].…”

Section: Introductionmentioning

confidence: 99%

T-cell responses to ancestral SARS-CoV-2 and Omicron variant among unvaccinated pregnant and postpartum women living with and without HIV in South Africa

McMahon,

Kwatra,

Izu

et al. 2023

Preprint

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SARS-CoV-2 cell-mediated immunity remains understudied during pregnancy in unvaccinated black African women living with HIV (WLWH) from low- and middle-income countries. We investigated SARS-CoV-2-specific T-cell responses one-month post infection in 24 HIV-uninfected women and 15 WLWH at any stage during pregnancy or postpartum. The full-length spike (FLS) glycoprotein and nucleocapsid (N) protein of wild-type (WT) SARS-CoV-2, as well as mutated spike protein regions found in the Omicron variant (B.1.1.529) were targeted by flow cytometry. WT-specific CD4+ and CD8+ T cells elicited similar FLS- and N-specific responses in HIV-uninfected women and WLWH. SARS-CoV-2-specific T-lymphocytes were TNF-α monofunctional in pregnant and postpartum women living with and without HIV, with fever cells producing either IFN-γ or IL-2. Furthermore, T-cell responses were unaffected by Omicron-specific spike mutations since similar responses between Omicron and the ancestral virus were detected for CD4+ and CD8+ T cells. Our results collectively demonstrate comparable T-cell responses between WLWH on antiretroviral therapy and HIV-uninfected pregnant and postpartum women who were naïve to Covid-19 vaccination. Additionally, we show that T cells from women infected with the ancestral virus, Beta variant (B.1.351), or Delta variant (B.1.617.2) can cross-recognize Omicron, which may suggest an overall preservation of T-cell immunity. MAIN TEXT

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Safety of COVID-19 vaccines during pregnancy: A systematic review and meta-analysis

Cited by 26 publications

References 142 publications

Patisiran exposure in early pregnancy: a case report

Patisiran exposure in early pregnancy: a case report

Pregnancy Outcomes among Pregnant Persons after COVID-19 Vaccination: Assessing Vaccine Safety in Retrospective Cohort Analysis of U.S. National COVID Cohort Collaborative (N3C)

T-cell responses to ancestral SARS-CoV-2 and Omicron variant among unvaccinated pregnant and postpartum women living with and without HIV in South Africa

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