Safety of COVID-19 vaccines in pregnancy: a Canadian National Vaccine Safety (CANVAS) network cohort study

Sadarangani, Manish; Soe, Phyumar; Shulha, Hennady P.; Valiquette, Louis; Vanderkooi, Otto G; Kellner, James D.; Muller, Matthew P.; Top, Karina A; Isenor, Jennifer E.; McGeer, Allison; Irvine, Michael A.; Serres, Gaston De; Marty, Kimberly; Bettinger, Julie A.

doi:10.1016/s1473-3099(22)00426-1

Cited by 57 publications

(50 citation statements)

References 23 publications

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“…It may be that recent experiences of discrimination during pregnancy exert a triggering effect on the hypothalamic-pituitary axis leading to the inflammatory cascade and vascular dysfunction that contribute to PTB. 13 This conceptual model fits with the few studies in this review that showed recent experiences versus lifetime experiences exerted a stronger effect on PTB. This review also highlights that the effects of racism have been poorly studied in relation to maternal outcomes and deserve to be the focus of further research.…”

supporting

confidence: 82%

“…The data being collected in the general population to date have been promising on short‐term safety of the current COVID‐19 vaccines except for rare problem of myocarditis in younger people, particularly men 11,12 . The same can be said for data on the safety of COVID‐19 vaccines in pregnancy from the United States and Canada, but both studies depended on self‐reported data, which are much more likely to be biased 13,14 . Longer‐term, well‐designed cohort studies will be needed to provide the best, unbiased information.…”

Section: Featured Reviewmentioning

confidence: 99%

“…11,12 The same can be said for data on the safety of COVID-19 vaccines in pregnancy from the United States and Canada, but both studies depended on self-reported data, which are much more likely to be biased. 13,14 Longer-term, well-designed cohort studies will be needed to provide the best, unbiased information. On the other hand, the influenza vaccine is a traditional vaccine has been administered to populations for 20 years.…”

Section: Systematic Reviews In Cdsr: Neonatal and Infant Healthmentioning

confidence: 99%

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Systematic Reviews to Inform Practice, November/December 2022

Barger¹

2022

J Midwife Womens Health

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supporting

confidence: 82%

Section: Featured Reviewmentioning

confidence: 99%

Section: Systematic Reviews In Cdsr: Neonatal and Infant Healthmentioning

confidence: 99%

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Systematic Reviews to Inform Practice, November/December 2022

Barger¹

2022

J Midwife Womens Health

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“…( 3 ) reported that in the United States, more than 35,691 pregnant women have been vaccinated with mRNA COVID-19 vaccines and a total of about 29,255 reports were received concerning local and systemic reactions. Additionally, a recent study found a lower rate of significant health events in pregnant women than non-pregnant individuals after COVID-19 vaccination ( 21 ).…”

Section: Discussionmentioning

confidence: 99%

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study

et al. 2022

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IntroductionAlthough the European Medicines Agency (EMA) encourage coronavirus disease 2019 (COVID-19) vaccination in pregnant women, the scientific evidence supporting the use of COVID-19 vaccines during pregnancy is still limited.AimWe aimed to investigate adverse events following immunization (AEFI) with COVID-19 vaccines during pregnancy.MethodsWe retrieved Individual Case Safety Reports (ICSRs) related to the use of COVID-19 vaccines during pregnancy from the EudraVigilance database for the year 2021. We analyzed AEFI related to the mother and fetus/newborn. The reporting odds ratio (ROR) was computed to compare the reporting probability of spontaneous abortion between COVID-19 vaccines.ResultsDuring the study period, among 1,315,315 ICSRs related to COVID-19 vaccines, we retrieved 3,252 (0.25%) reports related to the use in pregnancy. More than half (58.24%) of ICSRs were submitted by non-healthcare professionals. Although the majority (87.82%) of ICSRs concerned serious AEFI, their outcomes were mostly favorable. In this study, 85.0% of total ICSRs referred to pregnant women (n = 2,764), while 7.9% referred to fetuses/newborns (n = 258). We identified 16,569 AEFI. Moreover, 55.16% were AEFI not related to pregnancy (mostly headache, pyrexia, and fatigue), while 17.92% were pregnancy-, newborn-, or fetus-related AEFI. Among pregnancy-related AEFI, the most reported was spontaneous abortion. Messenger RNA (mRNA) vaccines had a lower reporting probability of spontaneous abortion than viral vector-based vaccines (ROR 0.80, 95% CI 0.69–0.93). Moderna and Oxford-AstraZeneca vaccines had a higher reporting probability of spontaneous abortion (ROR 1.2, 95% CI 1.05–1.38 and ROR 1.26, 95% CI 1.08–1.47, respectively), while a lower reporting probability was found for Pfizer-BioNTech vaccine compared with all other COVID-19 vaccines (ROR 0.73, 95% CI 0.64–0.84). In addition, 5.8% of ICSRs reported a fatal outcome.ConclusionsNo strong insight of unknown AEFI associated with COVID-19 vaccination in pregnant women was observed. Considering the high risk associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, our analysis suggests that the benefits of COVID-19 vaccines during pregnancy outweigh the possible risks. However, it is important to continue monitoring the safety profile of COVID-19 vaccines in this subpopulation.

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“…Las vacunas de ARNm COVID-19 han tenido un buen perfil de seguridad en el embarazo. Estos datos pueden utilizarse para informar adecuadamente a las gestantes sobre la reactogenicidad de las vacunas COVID-19 durante el embarazo y deben ser considerados junto con los datos de eficacia e inmunogenicidad para hacer recomendaciones adecuadas sobre el mejor uso de las vacunas COVID-19 en la gestación (27) .…”

Section: Vacunasunclassified

El enigma del coronavirus – ¿El final de la pandemia COVID-19? – La mujer, la gestante y el feto – Vacunas - Futuro

Romero¹

2022

Rev peru ginecol obstet.

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El Director General de la OMS Tedros Adhanom Ghebreyesus ha dicho recientemente que ‘Elfin de la pandemia está cerca. Todavía no hemos llegado, pero el final está a la vista’. Y elpresidente de los EE. UU. Joe Biden, con alrededor de 400 muertes por día en los EE. UU., harepetido dicha aseveración. Por lo que podemos leer en la literatura, aún no estaríamos en talsituación y pudiera haber un buen trecho por recorrer. Si bien se conoce más acerca del virusy su capacidad de transformación en variantes y subvariantes de manera de ingresar con másfacilidad al huésped, algunas de estas transformaciones son motivo de preocupación.Hacemos una revisión somera sobre lo aprendido sobre la morbimortalidad por el SARS-CoV-2, cómo ha empeorado la salud de las mujeres, algunas alteraciones en el esperma, lasdefensas ante el virus, las reinfecciones, su accionar malsano sobre la gestante, el feto y elneonato, las vacunas y refuerzos y una visión de lo que nos espera.

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Safety of COVID-19 vaccines in pregnancy: a Canadian National Vaccine Safety (CANVAS) network cohort study

Cited by 57 publications

References 23 publications

Systematic Reviews to Inform Practice, November/December 2022

Systematic Reviews to Inform Practice, November/December 2022

Maternal, fetal and neonatal outcomes among pregnant women receiving COVID-19 vaccination: The preg-co-vax study

El enigma del coronavirus – ¿El final de la pandemia COVID-19? – La mujer, la gestante y el feto – Vacunas - Futuro

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