Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis

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

doi:10.1097/md.0000000000032954

Cited by 4 publications

(2 citation statements)

References 35 publications

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“…Considering the growing body of evidence on this topic, we are conducting a living systematic review to evaluate the safety, immunogenicity, and efficacy/effectiveness of COVID-19 vaccines for pregnant persons. [156] The results are being presented in a web-based, highly parameterizable interface is provided that yields available estimates and live meta-analyses of the above outcomes of interest by relevant subgroups. [157] We included 134 studies (87% RNA vaccines) published until December 31, 2022.…”

Section: Discussionmentioning

confidence: 99%

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

Ciapponi

Berrueta

Parker

et al. 2023

Vaccine

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Section: Discussionmentioning

confidence: 99%

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

Ciapponi

Berrueta

Parker

et al. 2023

Vaccine

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“…Available literature presents a combination of systematic reviews and consensus-building processes used to harmonize pregnancy and child outcomes for monitoring safety of novel vaccines during pregnancy, mainly related to COVID-19 vaccination in low-and middle-income countries (LMICs) [18][19][20][21][22][23]. So far, no uni ed set of outcomes has been proposed for maternal and perinatal research conducted during emerging and ongoing epidemic threats.…”

Section: Introductionmentioning

confidence: 99%

A systematic review of maternal and perinatal health outcomes in the context of epidemic threats: towards the development of a core outcome set.

Mazzoni,

Berrueta,

Babinska

et al. 2024

Preprint

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Objective To systematically identify and classify maternal and perinatal health outcomes reported in research conducted in the epidemic and pandemic context. Study design and Setting We conducted a systematic review following Cochrane Methods. We searched MEDLINE, EMBASE, LILACS, SCI-EXPANDED, CINAHL, Cochrane Central Register of Controlled Trials, PsycINFO, AMED, ClinicalTrials.gov and ICTRP, between January 2015 and March 2023. Experimental, quasi-experimental, observational studies, phase IV trials, and post-marketing studies, published protocols and ongoing registered studies reporting maternal and perinatal health outcomes were included. Studies only reporting coverage of interventions, access to routine health services, clinical presentation of infectious diseases, and reviews were excluded. A sampling strategy was used for COVID-19 studies, due to their very high numbers. Outcome verbatims were extracted and categorized in unique outcome, and further classified into domains and subdomains. Frequency of outcome reporting was calculated. Results 94 maternal and pregnancy and 47 unique neonatal outcomes were identified, from a total of 917 and 657 verbatims, respectively, reported across 440 included studies. At least 20% of included studies reported maternal and pregnancy outcomes of mode of delivery (56.1%), stillbirth (33.0%), preterm birth (28.6%), hypertensive disorders of pregnancy (26.6%), and maternal death (20.7%). These outcomes were identified across all three types of studies identified (epidemiological, product development or post-authorization surveillance). Gestational age at birth (29.8%), congenital malformations of the nervous system (26.1%), birth weight (23.4%), neonatal admission to intensive care unit (23.2%), and neonatal death (19.1%) were the most frequently reported neonatal outcomes. Conclusions Our study provides the basis for developing a core outcome set to measure maternal and perinatal health during outbreaks, which would help improve data collection of harmonized data, data synthesis, and timely development of informed public health guidance and clinical care responding to the needs of pregnant women. .

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Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis

Ciapponi,

Berrueta,

Argento

et al. 2024

Drug Saf

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Background Pregnant persons are susceptible to significant complications following COVID-19, even death. However, worldwide COVID-19 vaccination coverage during pregnancy remains suboptimal. Objective This study assessed the safety and effectiveness of COVID-19 vaccines administered to pregnant persons and shared this evidence via an interactive online website. Methods We followed Cochrane methods to conduct this living systematic review. We included studies assessing the effects of COVID-19 vaccines in pregnant persons. We conducted searches every other week for studies until October 2023, without restrictions on language or publication status, in ten databases, guidelines, preprint servers, and COVID-19 websites. The reference lists of eligible studies were hand searched to identify additional relevant studies. Pairs of review authors independently selected eligible studies using the web-based software COVIDENCE. Data extraction and risk of bias assessment were performed independently by pairs of authors. Disagreements were resolved by consensus. We performed random-effects meta-analyses of adjusted relative effects for relevant confounders of comparative studies and proportional meta-analyses to summarize frequencies from one-sample studies using R statistical software. We present the GRADE certainty of evidence from comparative studies. Findings are available on an interactive living systematic review webpage, including an updated evidence map and real-time meta-analyses customizable by subgroups and filters. Results We included 177 studies involving 638,791 participants from 41 countries. Among the 11 types of COVID-19 vaccines identified, the most frequently used platforms were mRNA (154 studies), viral vector (51), and inactivated virus vaccines (17). Low to very low-certainty evidence suggests that vaccination may result in minimal to no important differences compared to no vaccination in all assessed maternal and infant safety outcomes from 26 fewer to 17 more events per 1000 pregnant persons, and 13 fewer to 9 more events per 1000 neonates, respectively. We found statistically significant reductions in emergency cesarean deliveries (9%) with mRNA vaccines, and in stillbirth (75–83%) with mRNA/viral vector vaccines. Low to very low-certainty evidence suggests that vaccination during pregnancy with mRNA vaccines may reduce severe cases or hospitalizations in pregnant persons with COVID-19 (72%; 95% confidence interval [CI] 42–86), symptomatic COVID-19 (78%; 95% CI 21–94), and virologically confirmed SARS-CoV-2 infection (82%; 95% CI 39–95). Reductions were lower with other vaccine types and during Omicron variant dominance than Alpha and Delta dominance. Infants also presented with fewer severe cases or hospitalizations due to COVID-19 and laboratory-confirmed SARS-CoV-2 infection (64%; 95% CI 37–80 and 66%; 95% CI 37–81, respectively). Conclusions We found a large body of e...

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Safety, immunogenicity, and effectiveness of COVID-19 vaccines for pregnant persons: A protocol for systematic review and meta analysis

Cited by 4 publications

References 35 publications

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

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

A systematic review of maternal and perinatal health outcomes in the context of epidemic threats: towards the development of a core outcome set.

Safety and Effectiveness of COVID-19 Vaccines During Pregnancy: A Living Systematic Review and Meta-analysis

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