Safety of COVID-19 Vaccination in Pregnancy: A Systematic Review.
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ABSTRACT:
SUBMITTER: Gerede A
PROVIDER: S-EPMC11354065 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
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Safety of COVID-19 Vaccination in Pregnancy: A Systematic Review.
Gerede Angeliki A Daskalakis Georgios G Mikos Themistoklis T Chatzakis Christos C Vavoulidis Eleftherios E Eleftheriades Makarios M Domali Ekaterini E Nikolettos Konstantinos K Oikonomou Efthymios E Antsaklis Panagiotis P Theodora Marianna M Psarris Alexandros A Margioula-Siarkou Chrysoula C Petousis Stamatios S Stavros Sofoklis S Potiris Anastasios A Athanasiadis Apostolos A Dinas Konstantinos K Tsikouras Panagiotis P Nikolettos Nikolaos N Sotiriadis Alexandros A
Diagnostics (Basel, Switzerland) 20240814 16
The COVID-19 pandemic has posed significant risks to pregnant women and those recently pregnant, leading to heightened mortality and morbidity rates. Vaccination has emerged as a pivotal strategy in reducing COVID-19-related deaths and illnesses worldwide. However, the initial exclusion of pregnant individuals from most clinical trials raised concerns about vaccine safety in this population, contributing to vaccine hesitancy. This review aims to consolidate the existing literature to assess the ...[more]
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Project description:BackgroundSARS-CoV-2 exposure during pregnancy is related to adverse effects for both the mother and the infant. SARS-CoV-2 vaccination has lowered the risk of symptomatic disease substantially. Recently published studies have evaluated the outcomes of women who received the COVID-19 vaccine during pregnancy; systematic evidence regarding vaccination safety is crucial to ensure that COVID-19 vaccination is not associated with adverse pregnancy and neonatal outcomes.MethodsPubmed/MEDLINE, EMBASE, Scopus, Web of Science, and Clinicaltrials.gov were searched from each database's inception through April 7, 2022. All interventional and observational studies comparing neonatal or pregnancy outcomes between pregnant women who received COVID-19 vaccines during their pregnancy and unvaccinated pregnant women were included. The random-effects model was used in the meta-analyses.ResultsA total of 11 studies comprising 756,098 pregnant mothers were included. The rate of neonates with 5-min Apgar score ≤ 7 (log RR -0.08 (95% CI: -0.15 to -0.00), (P = 0.03)) and pregnant mothers with preterm birth (log RR -0.11 (95% CI: -0.21 to -0.01), (P = 0.02)) was significantly lower among vaccinated group. No significant difference was observed in adverse neonatal outcomes (log RR -0.07 (95% CI: -0.17 to 0.03)), small for gestational age (log RR -0.06 (95% CI: -0.14 to 0.02)), caesarean delivery (log RR 0.05 (95% CI: -0.05 to 0.15)), postpartum hemorrhage (log RR -0.05 (95% CI: -0.13 to 0.02)), stillbirth (log RR -0.05 (95% CI: -0.54 to 0.45)).Conclusions and relevanceIn this systematic review and meta-analysis, no evident differences were observed when comparing vaccinated pregnant mothers with those who had not received COVID-19 vaccines. Based on low certainty of evidence, vaccination during pregnancy was accompanied by a favorable Apgar score in neonates and fewer preterm births.
| S-EPMC9853484 | biostudies-literature
Project description:ObjectiveWe conducted a systematic review to evaluate associations between influenza vaccination during pregnancy and adverse birth outcomes and maternal non-obstetric serious adverse events (SAEs), taking into consideration confounding and temporal biases.MethodsElectronic databases (Ovid MEDLINE ALL, Embase Classic+Embase and the Cochrane Central Register of Controlled Trials) were searched to June 2021 for observational studies assessing associations between influenza vaccination during pregnancy and maternal non-obstetric SAEs and adverse birth outcomes, including preterm birth, spontaneous abortion, stillbirth, small-for-gestational-age birth and congenital anomalies. Studies of live attenuated vaccines, single-arm cohort studies and abstract-only publications were excluded. Records were screened using a liberal accelerated approach initially, followed by a dual independent approach for full-text screening, data extraction and risk of bias assessment. Pairwise meta-analyses were conducted, where two or more studies met methodological criteria for inclusion. The Grading of Recommendations, Assessment, Development and Evaluation approach was used to assess evidence certainty.ResultsOf 9443 records screened, 63 studies were included. Twenty-nine studies (24 cohort and 5 case-control) evaluated seasonal influenza vaccination (trivalent and/or quadrivalent) versus no vaccination and were the focus of our prioritised syntheses; 34 studies of pandemic vaccines (2009 A/H1N1 and others), combinations of pandemic and seasonal vaccines, and seasonal versus seasonal vaccines were also reviewed. Control for confounding and temporal biases was inconsistent across studies, limiting pooling of data. Meta-analyses for preterm birth, spontaneous abortion and small-for-gestational-age birth demonstrated no significant associations with seasonal influenza vaccination. Immortal time bias was observed in a sensitivity analysis of meta-analysing risk-based preterm birth data. In descriptive summaries for stillbirth, congenital anomalies and maternal non-obstetric SAEs, no significant association with increased risk was found in any studies. All evidence was of very low certainty.ConclusionsEvidence of very low certainty suggests that seasonal influenza vaccination during pregnancy is not associated with adverse birth outcomes or maternal non-obstetric SAEs. Appropriate control of confounding and temporal biases in future studies would improve the evidence base.
| S-EPMC10496691 | biostudies-literature
Project description:BackgroundThe safety of coronavirus disease 2019 (COVID-19) vaccines during pregnancy is a particular concern. Here, we addressed the neonatal outcomes after maternal vaccination of COVID-19 during pregnancy.MethodsWe systematically searched PubMed, EMBASE, and the WHO COVID-19 Database for studies on neonatal outcomes after maternal COVID-19 vaccination from inception to 3 July 2022. Main neonatal outcomes were related to preterm, small for gestation (SGA), NICU admission, low Apgar score at 5 min (<7), and additional neonatal outcomes such as gestation <34 weeks, low birth weight and some neonatal morbidity were all also analyzed.ResultsA total of 15 studies were included. We found that maternal vaccination during pregnancy was related to the reduction rates of Preterm, SGA, Low Apgar score at 5 min (<7). In addition, there was no evidence of a higher risk of adverse neonatal outcomes after maternal vaccination of COVID-19 during pregnancy, including NICU admission, preterm birth with gestation <34 weeks, low birth weight, very low birth weight, congenital anomalies, and so on.ConclusionsCOVID-19 vaccination in pregnant women does not raise significant adverse effects on neonatal outcomes and is related to a protective effect on some neonatal outcomes.ImpactPresent study has addressed the neonatal outcomes after maternal vaccination of COVID-19 during pregnancy. COVID-19 vaccination in pregnant women does not raise significant adverse effects on neonatal outcomes and is related to a protective effect on some neonatal outcomes. The present study could encourage pregnant women to be vaccinated against COVID-19.
| S-EPMC9808682 | biostudies-literature
Project description:BackgroundAssessment of COVID-19 vaccines safety during pregnancy is urgently needed.MethodsWe conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185).ResultsWe retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49-15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56-2.12). Animal studies showed consistent results with studies in pregnant persons.ConclusionWe found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.
| S-EPMC10040368 | biostudies-literature
Project description:ObjectivesThis study aimed to provide guidance for clinical treatment and increase public confidence in COVID-19 vaccines.MethodsThe Cochrane Library, Embase, PubMed, Web of Science, ClinicalKey, and other COVID-19 datasets were searched from December 2019 to May 2022. Case-control studies and prospective cohort studies of COVID-19 vaccine effectiveness and safety in pregnant women were included.ResultsFrom day 11 to day 13, after the first dose of the COVID-19 messenger RNA vaccine, the effectiveness was 54% (95% confidence interval: 0.33-0.69). On days 14 to 27, the effectiveness was 59%. There was a 14% increase in vaccine effectiveness 28 days after the first dose was given. The inactivated vaccines showed similar effectiveness. The proportions of placental abruptions, postpartum hemorrhages, miscarriages, stillbirths, premature births, and small for gestational age infants were not significantly different between vaccinated and nonvaccinated pregnant women. Fatigue and fever were also not associated with pregnancy.ConclusionOur findings affirm that the effectiveness varies for different types of vaccines and is significantly and positively correlated with time in the pregnant population. COVID-19 vaccines have also been deemed safe for pregnant women. Thus, we developed a comprehensive understanding of the role of vaccines in pregnant women.
| S-EPMC9873368 | biostudies-literature
Project description:Vaccination has become an essential means of protection for solid tumour patients against coronavirus disease 2019 (COVID-19). In this systematic review, we sought to identify common safety profiles of the COVID-19 vaccine in patients with solid tumours. A search of Web of Science, PubMed, EMBASE and Cochrane was conducted for studies in English full-text that reported side-effect data experienced by patients with cancer who were at least 12 years old with solid tumours or a recent history of solid tumours after receiving either one or multiple doses of the COVID-19 vaccination. Study quality was assessed with the Newcastle Ottawa Scale criteria. Acceptable study types were retrospective and prospective cohorts, retrospective and prospective observational studies, observational analyses and case series; systematic reviews, meta-analyses and case reports were excluded. Among local/injection site symptoms, the most commonly reported were injection site pain and ipsilateral axillary/clavicular lymphadenopathy, whereas the most commonly reported systemic effects were fatigue/malaise, musculoskeletal symptoms and headache. Most side-effects reported were characterised as mild to moderate. A thorough evaluation of the randomised controlled trials for each featured vaccine led to the conclusion that in the USA and abroad, the safety profile seen in patients with solid tumours is comparable with that seen in the general public.
| S-EPMC10014476 | biostudies-literature
Project description:ImportanceThe risk and benefits of COVID-19 vaccination during pregnancy are under investigation. Pooled evidence regarding neonatal and maternal outcomes in association with COVID-19 vaccination during pregnancy is scarce.ObjectiveTo evaluate the association between COVID-19 vaccination during pregnancy and peripartum outcomes.Data sourcesPubMed and EMBASE databases were searched on April 5, 2022. Language restrictions were not applied.Study selectionProspective trials and observational studies comparing the individuals who received at least 1 COVID-19 vaccination during pregnancy with those who did not and reporting the neonatal outcomes, including preterm birth, small for gestational age, low Apgar score, neonatal intensive care units (NICU) admission, and intrauterine fetal death (IFD).Data extraction and synthesisTwo independent investigators extracted relevant data from each study. Odds ratios (ORs) were calculated using a random-effects model. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines.Main outcomes and measuresThe primary outcomes were the neonatal outcomes, including preterm birth, small for gestational age, low Apgar score, NICU admission, and IFD. The secondary outcomes were maternal outcomes, including maternal SARS-CoV-2 infection, cesarean delivery, postpartum hemorrhage, and chorioamnionitis.ResultsNine observational studies involving 81 349 vaccinated (mean age, 32-35 years) and 255 346 unvaccinated individuals during pregnancy (mean age, 29.5-33 years) were included. COVID-19 vaccination during pregnancy was associated with lower risk of NICU admission (OR, 0.88; 95% CI, 0.80-0.97) and IFD (OR, 0.73; 95% CI, 0.57-0.94), whereas there was no statistically significant association with preterm birth (OR, 0.89; 95% CI, 0.76-1.04), small for gestational age (OR, 0.99; 95% CI, 0.94-1.04), and low Apgar score (OR, 0.94; 95% CI, 0.87-1.02). COVID-19 vaccination during pregnancy was associated with a lower risk of maternal SARS-CoV-2 infection (OR, 0.46; 95% CI, 0.22-0.93), whereas it was not associated with increased risk of cesarean delivery (OR, 1.05; 95% CI, 0.93-1.20), postpartum hemorrhage (OR, 0.95; 95% CI, 0.83-1.07), and chorioamnionitis (OR, 0.95; 95% CI, 0.83-1.07).Conclusions and relevanceCOVID-19 vaccination during pregnancy was not associated with an increase in the risk of peripartum outcomes, was associated with a decreased risk of NICU admission, IFD, and maternal SARS-CoV-2 infection. Thus, COVID-19 vaccination should be encouraged for pregnant individuals.
| S-EPMC9531099 | biostudies-literature
Project description:Despite a recent endorsement from official and professional bodies unequivocally recommending COVID-19 vaccination, vaccine hesitancy among pregnant people remains high. The accumulated evidence demonstrates that pregnant people are a special risk group for COVID-19, with an increased risk of intensive care unit admission, extracorporeal membranous oxygenation requirement, preterm birth, and perinatal death. These risks are further increased with some variants of concern, and vaccination of pregnant people reduces the COVID-19-related increase in maternal or fetal morbidity. Data from more than 180,000 vaccinated persons show that immunization against COVID-19 with an mRNA vaccine is safe for pregnant people. Many observational studies comparing perinatal outcomes between vaccinated and unvaccinated pregnant people have had reassuring findings and did not demonstrate harmful effects on pregnancy or the newborn. Immunization with mRNA vaccines does not increase the risk of miscarriage, preterm delivery, low birthweight, maternal or neonatal intensive care unit admission, fetal death, fetal abnormality, or pulmonary embolism. Moreover, observational data corroborate the findings of randomized trials that mRNA vaccination is highly effective at preventing severe SARS-CoV-2 infection in pregnant people, emphasizing that the potential maternal and fetal benefits of vaccination greatly outweigh the potential risks of vaccination. Ensuring pregnant people have unrestricted access to COVID-19 vaccination should be a priority in every country worldwide.
| S-EPMC9093065 | biostudies-literature
Project description:BACKGROUND:Infants < 3 months of age are at highest risk for developing severe complications after pertussis. The majority of pregnant women has low concentrations of pertussis-specific antibodies and thus newborns are insufficiently protected by maternally transferred antibodies. Acellular pertussis vaccination during pregnancy was recently implemented in various countries. Here, we assessed the evidence for safety and effectiveness of pertussis vaccination during pregnancy. METHODS:We searched Medline, Embase, and ClinicalTrials.gov from January 1st 2010 to January 10th 2019. We assessed risk of bias (ROB) using the Cochrane ROB tool and ROBINS-I. We evaluated the quality of evidence using the GRADE approach. RESULTS:We identified 1273 articles and included 22 studies (14 for safety; 8 for effectiveness), comprising 1.4 million pregnant women in safety studies and 855,546 mother-infant-pairs in effectiveness studies. No significant differences between vaccinated and unvaccinated women and their infants were observed for safety outcomes with the exception of fever and chorioamnionitis. Compared to no vaccination, three studies showed a significantly increased relative risk for the presence of the ICD-9 code for chorioamnionitis in electronic patient data after pertussis vaccination. However, no study reported an increased risk for clinical sequelae of chorioamnionitis after vaccination during pregnancy, such as preterm birth or neonatal intensive care unit admission. Vaccine effectiveness against pertussis in infants of immunized mothers ranged from 69 to 91% for pertussis prevention, from 91 to 94% for prevention of hospitalization and was 95% for prevention of death due to pertussis. Risk of bias was serious to critical for safety outcomes and moderate to serious for effectiveness outcomes. GRADE evidence quality was moderate to very low, depending on outcome. CONCLUSION:Although an increased risk for a diagnosis of fever and chorioamnionitis was detected in pregnant women after pertussis vaccination, there was no association with a higher frequency of clinically relevant sequelae. Vaccine effectiveness for prevention of infant pertussis, hospitalization and death is high. Pertussis vaccination during pregnancy has an overall positive benefit-risk ratio. In view of the overall quality of available evidence ongoing surveillance of chorioamnionitis and its potential sequelae is recommended when pertussis vaccination in pregnancy is implemented. TRIAL REGISTRATION:PROSPERO CRD42018087814, CRD42018090357.
| S-EPMC7020352 | biostudies-literature
Project description:Post COVID-19 condition (PCC) refers to persistent or recurring symptoms (>8 weeks) occurring ≤12 weeks following acute COVID-19. The objective of this systematic review was to assess the evidence on the risk of PCC with vaccination before or after COVID-19 or after developing PCC, and the safety of vaccination among those already experiencing PCC. A search was conducted up to 13 December 2022 and standard systematic review methodology was followed. Thirty-one observational studies were included. There is moderate confidence that two doses of vaccine given pre-infection reduced the odds of PCC (pooled OR (pOR) 0.67, 95% CI 0.60-0.74, I2 = 59.9%), but low confidence that one dose may not reduce the odds (pOR 0.64, 95% CI 0.31#x2013;1.31, I2 = 99.2%), and the evidence is very uncertain about the effect of three doses (pOR 0.45, 95% CI 0.10#x2013;1.99, I2 = 30.9%). One of three studies suggested vaccination shortly after COVID-19 may offer additional protection from developing PCC compared to unvaccinated individuals, but this evidence was very uncertain. For those with PCC, vaccination was not associated with worsening PCC symptoms (10 studies) and appears safe (3 studies), but it is unclear if vaccination may change established PCC symptoms.
| S-EPMC10540166 | biostudies-literature