Benefits and potential harms of <scp>COVID</scp>‐19 vaccination during pregnancy: evidence summary for patient counseling

Kalafat, Erkan; O’Brien, Patrick; Heath, Paul T; Doaré, Kirsty Le; Dadelszen, Peter von; Magee, Laura A.; Ladhani, Shamez; Khalil, Asma

doi:10.1002/uog.23631

Cited by 22 publications

(24 citation statements)

References 35 publications

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“…At present, data on the safety and efficacy of COVID-19 vaccination in pregnancy are limited owing to the exclusion of pregnant women in clinical trials, 34 although trials are now underway to address this urgent need. This has motivated widespread hesitancy about recommendation of vaccination to all pregnant women, with governments and professional organizations initially recommending offering vaccination to pregnant women at high risk of either occupational exposure or severe disease 35 and pregnant women reluctant to take up a vaccine offer. 36 In the United States and Israel, where vaccination has been recommended to those at a higher risk, initial data provide a positive signal of safety and efficacy in pregnant women.…”

Section: Clinical and Research Implicationsmentioning

confidence: 99%

Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection at the time of birth in England: national cohort study

Gurol‐Urganci

Jardine

Carroll

et al. 2021

American Journal of Obstetrics and Gynecology

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233

190

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BACKGROUND: Some studies have suggested that women with SARS-CoV-2 infection during pregnancy are at increased risk of adverse pregnancy and neonatal outcomes, but these associations are still not clear. OBJECTIVE: This study aimed to determine the association between SARS-CoV-2 infection at the time of birth and maternal and perinatal outcomes. STUDY DESIGN: This is a population-based cohort study in England. The inclusion criteria were women with a recorded singleton birth between May 29, 2020, and January 31, 2021, in a national database of hospital admissions. Maternal and perinatal outcomes were compared between pregnant women with a laboratory-confirmed SARS-CoV-2 infection recorded in the birth episode and those without. Study outcomes were fetal death at or beyond 24 weeks' gestation (stillbirth), preterm birth (<37 weeks' gestation), small for gestational age infant (small for gestational age; birthweight at the .05) in the rate of other maternal outcomes. The risk of neonatal adverse outcome (adjusted odds ratio, 1.45; 95% confidence interval, 1.27e1.66; P<.001), need for specialist neonatal care (adjusted odds r...

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Section: Clinical and Research Implicationsmentioning

confidence: 99%

Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection at the time of birth in England: national cohort study

Gurol‐Urganci

Jardine

Carroll

et al. 2021

American Journal of Obstetrics and Gynecology

Self Cite

233

190

View full text Add to dashboard Cite

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“…2 Theoretically, COVID-19 vaccines are safe for use in pregnancy, as they do not contain a live attenuated virus. 3 For COVID-19 vaccination in pregnancy, there has been no major safety signal from animal reproductive toxicology studies, the very small number of inadvertent pregnancies in vaccine trials, the Centers for Disease Control and Prevention (CDC) V-safe postvaccination health checker (with limited data on >30,000 pregnant women, but only 827 women have given birth), or a formal pregnancy registry (>1800 enrolled to date). 4 A recent report of American health workers who were pregnant (n¼84) or lactating (n¼31) when vaccinated found that compared with nonpregnant controls (n¼16), vaccine-induced humoral immunity was similar, antibody titers were higher following an actual SARS-CoV-2 infection, and antibodies were present in umbilical cord blood and breast milk, suggesting that vaccination can confer maternal and perinatal immunity.…”

Section: Introductionmentioning

confidence: 99%

COVID-19 vaccination during pregnancy: coverage and safety

Blakeway

Prasad

Kalafat

et al. 2022

American Journal of Obstetrics and Gynecology

323

354

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Background Concerns have been raised regarding a potential surge of COVID-19 in pregnancy, secondary to rising numbers of COVID-19 in the community, easing of societal restrictions, and vaccine hesitancy. Even though COVID-19 vaccination is now offered to all pregnant women in the UK, there are limited data on its uptake and safety. Objectives and study design : This was a cohort study of pregnant women who gave birth at St George’s University Hospitals NHS Foundation Trust, London, UK, between March 1 st and July 4 th 2021. The primary outcome was uptake of COVID-19 vaccination and its determinants. The secondary outcomes were perinatal safety outcomes. Data were collected on COVID-19 vaccination uptake, vaccination type, gestational age at vaccination, as well as maternal characteristics including age, parity, ethnicity, index of multiple deprivation score and co-morbidities. Further data were collected on perinatal outcomes including stillbirth (fetal death ≥24 weeks’ gestation), preterm birth, fetal/congenital abnormalities and intrapartum complications. Pregnant women who received the vaccine were compared with a matched cohort of propensity balanced pregnant women to compare outcomes. Effect magnitudes of vaccination on perinatal outcomes were reported as mean differences or odds ratios with 95% confidence intervals. Factors associated with antenatal vaccination were assessed with logistic regression analysis. Results Data were available for 1328 pregnant women of whom 141 received at least one dose of vaccine before giving birth and 1187 women who did not; 85.8% of those vaccinated received their vaccine in the third trimester and 14.2% in the second trimester. Of those vaccinated, 128 (90.8%) received an mRNA vaccine and 13 (9.2%) a viral vector vaccine. There was evidence of reduced vaccine uptake in younger women (P=0.002), those with high levels of deprivation (i.e., fifth quintile of Index of Multiple Deprivation, P=0.008) and women of Afro-Caribbean or Asian ethnicity, compared to Caucasian ethnicity (P<0.001). Women with pre-pregnancy diabetes had increased vaccine uptake (P=0.008). In the multivariable model adjusting for variables that had a significant effect according to the univariable analysis, fifth deprivation quintile (most deprived) was significantly associated with lower antenatal vaccine uptake (adjusted OR 0.09, 95% CI 0.02–0.39, P=0.002), while pre-pregnancy diabetes was significantly associated with higher antenatal vaccine uptake (adjusted OR 11.1, 95% CI 2.01–81.6, P=0.008). In a propensity score matched cohort, compared with non-vaccinated pregnant women, 133 women who received at least one dose of the COVID-19 vaccine in pregnancy (vs. those unvaccinated) had similar rates of adverse pregnancy outcomes (P>0.05 for all): stillbirth (0.0% vs 0.3%), fetal abnormalities (2.2% vs 2.7%), intrapartum pyrexia (3.7% vs 1.5%), postpartum hemorrhage ...

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“…These spike proteins are expressed on the cellular surface, triggering the activation of cell-mediated and humoral immune systems and the creation of B memory cells which produce SARS-CoV-2-spike protein specific antibodies. The vaccine mRNA does not enter the nucleus or change host DNA, 63 are replication-deficient and have short lifespan characteristics, thus the likelihood of transplacental transfer of mRNA vaccine active compounds is low. 57,64,65 Pfizer-BioNTech's BNT162b2's Phase 3 clinical trial data reports side-effects such as local injection-site reactions (66%-88%), and mild to moderate systemic events including fever, fatigue, headache, and musculoskeletal pain (less than 60%).…”

Section: Covid-19 Vaccinesmentioning

confidence: 99%

“…These spike proteins are expressed on the cellular surface, triggering the activation of cell‐mediated and humoral immune systems and the creation of B memory cells which produce SARS‐CoV‐2‐spike protein specific antibodies. The vaccine mRNA does not enter the nucleus or change host DNA, 63 are replication‐deficient and have short lifespan characteristics, thus the likelihood of transplacental transfer of mRNA vaccine active compounds is low. 57 , 64 , 65…”

Section: Covid‐19 Vaccinesmentioning

confidence: 99%

A reasoned approach towards administering COVID‐19 vaccines to pregnant women

et al. 2021

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What is already known about this topic? COVID-19 infection in pregnancy leads to an increase in adverse maternal outcomes. Owing to paucity of data regarding SARS-CoV-2 vaccine use in pregnancy there is uncertainty regarding safety of use and subsequent pregnancy outcomes. What does this study add? Provides an overview of the available SARS-CoV-2 vaccines, their mechanisms of action and feasibility of use in pregnancy. Summarises recommendations regarding vaccination of pregnant or lactating women. Data Availability-Data sharing is not applicable to this article as no new data were created or analyzed in this study. Acknowledgements:We would like to acknowledge Mr Mohesh K Mohan for his assistance in the illustration, Ms Cecille Laureano Asibal for her administrative support.

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Benefits and potential harms of COVID‐19 vaccination during pregnancy: evidence summary for patient counseling

Abstract: This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as

Cited by 22 publications

References 35 publications

Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection at the time of birth in England: national cohort study

Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection at the time of birth in England: national cohort study

COVID-19 vaccination during pregnancy: coverage and safety

A reasoned approach towards administering COVID‐19 vaccines to pregnant women

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