Dataset Information

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

ABSTRACT:

Introduction

Numerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding the safety of these vaccines for the pregnant person and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, reactogenicity, immunogenicity, and efficacy of COVID-19 vaccines for pregnant persons and neonates are becoming increasingly available. A living systematic review and meta-analysis of the safety and effectiveness of COVID-19 vaccines for pregnant persons and newborns could provide the information necessary to help guide vaccine policy decisions.

Methods and analysis

We aim to conduct a living systematic review and meta-analysis based on biweekly searches of medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries to systematically identify relevant studies of COVID-19 vaccines for pregnant persons. Pairs of reviewers will independently select, extract data, and conduct risk of bias assessments. We will include randomized clinical trials, quasi-experimental studies, cohort, case-control, cross-sectional studies, and case reports. Primary outcomes will be the safety, efficacy, and effectiveness of COVID-19 vaccines in pregnant persons, including neonatal outcomes. Secondary outcomes will be immunogenicity and reactogenicity. We will conduct paired meta-analyses, including prespecified subgroup and sensitivity analyses. We will use the grading of recommendations assessment, development, and evaluation approach to evaluate the certainty of evidence.

SUBMITTER: Ciapponi A

PROVIDER: S-EPMC9981247 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

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

Ciapponi Agustín A Berrueta Mabel M Ballivian Jamile J Bardach Ariel A Mazzoni Agustina A Anderson Steven S Argento Fernando J FJ Bok Karin K Comandé Daniel D Goucher Erin E Kampmann Beate B Parker Edward P K EPK Rodriguez-Cairoli Federico F Santa Maria Victoria V Stergachis Andy A Voss Gerald G Xiong Xu X Zaraa Sabra S Munoz Flor M FM Karron Ruth A RA Gottlieb Sami L SL Buekens Pierre M PM

Medicine 20230301 9

<h4>Introduction</h4>Numerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding the safety of these vaccines for the pregnant person and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, reactogenicity, immunogenicity, and efficacy of COVID-19 vaccines for p ...[more]

PMID: 36862871

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Project description:ObjectiveThe presented meta-analysis (MA) aims at identifying the vaccine safety and immunogenicity in published trials about SARS-CoV-2 vaccines.MethodsAll relevant publications were systematically searched and collected from different databases (Embase, Scopus, EBSCO, MEDLINE central/PubMed, Science Direct, Cochrane Central Register for Clinical Trials (CENTRAL), Clinical Trials.gov, WHO International Clinical Trials Registry Platform (ICTRP), COVID Trial, COVID Inato, Web of Science, ProQuest Thesis, ProQuest Coronavirus Database, SAGE Thesis, Google Scholar, Research Square, and Medxriv) up to January 10, 2021. The pooled vaccine safety and immunogenicity following vaccination in phase 1 and 2 vaccine clinical trials, as well as their 95% confidence intervals (CI), were estimated using the random-effects model.ResultsThe predefined inclusion criteria were met in 22 out of 8592 articles. The proportion of anti-severe acute respiratory distress coronavirus 2 (SARS-CoV-2) antibody responses after 7 days among 72 vaccinated persons included in 1 study was 81% (95% CI: 70-89), after 14 days among 888 vaccinated persons included in 6 studies was 80% (95% CI: 58-92), after 28 days among 1589 vaccinated persons included in 6 studies was 63% (95% CI: 59-67), after 42 days among 478 vaccinated persons included in 5 studies was 93% (95% CI: 80-98), and after 56 days among 432 vaccinated persons included in 2 studies was 93% (95% CI: 83-97). Meta regression explains more than 80% of this heterogeneity, where the main predictors were; the inactivated vaccine type (β = 2.027, P = 0.0007), measurement of antibodies at week 1 (β = -4.327, P < 0.0001) and at week 3 of the first dose (β = -2.02, P = 0.0025). Furthermore, the pooled proportion adverse effects 7 days after vaccination was 0.01 (0.08-0.14) for fever, headache 0.23 (0.19-0.27), fatigue 0.10 (0.07-0.13), and 0.18 (0.14-0.23) for muscle pain.ConclusionImmunogenicity following vaccination ranged from 63% to 93% depending on the time at which the antibody levels were measured.

Project description:ImportancePregnant women are at increased risk of morbidity and mortality from COVID-19 but have been excluded from the phase 3 COVID-19 vaccine trials. Data on vaccine safety and immunogenicity in these populations are therefore limited.ObjectiveTo evaluate the immunogenicity of COVID-19 messenger RNA (mRNA) vaccines in pregnant and lactating women, including against emerging SARS-CoV-2 variants of concern.Design, setting, and participantsAn exploratory, descriptive, prospective cohort study enrolled 103 women who received a COVID-19 vaccine from December 2020 through March 2021 and 28 women who had confirmed SARS-CoV-2 infection from April 2020 through March 2021 (the last follow-up date was March 26, 2021). This study enrolled 30 pregnant, 16 lactating, and 57 neither pregnant nor lactating women who received either the mRNA-1273 (Moderna) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines and 22 pregnant and 6 nonpregnant unvaccinated women with SARS-CoV-2 infection.Main outcomes and measuresSARS-CoV-2 receptor binding domain binding, neutralizing, and functional nonneutralizing antibody responses from pregnant, lactating, and nonpregnant women were assessed following vaccination. Spike-specific T-cell responses were evaluated using IFN-γ enzyme-linked immunospot and multiparameter intracellular cytokine-staining assays. Humoral and cellular immune responses were determined against the original SARS-CoV-2 USA-WA1/2020 strain as well as against the B.1.1.7 and B.1.351 variants.ResultsThis study enrolled 103 women aged 18 to 45 years (66% non-Hispanic White) who received a COVID-19 mRNA vaccine. After the second vaccine dose, fever was reported in 4 pregnant women (14%; SD, 6%), 7 lactating women (44%; SD, 12%), and 27 nonpregnant women (52%; SD, 7%). Binding, neutralizing, and functional nonneutralizing antibody responses as well as CD4 and CD8 T-cell responses were present in pregnant, lactating, and nonpregnant women following vaccination. Binding and neutralizing antibodies were also observed in infant cord blood and breast milk. Binding and neutralizing antibody titers against the SARS-CoV-2 B.1.1.7 and B.1.351 variants of concern were reduced, but T-cell responses were preserved against viral variants.Conclusion and relevanceIn this exploratory analysis of a convenience sample, receipt of a COVID-19 mRNA vaccine was immunogenic in pregnant women, and vaccine-elicited antibodies were transported to infant cord blood and breast milk. Pregnant and nonpregnant women who were vaccinated developed cross-reactive antibody responses and T-cell responses against SARS-CoV-2 variants of concern.

Project description:BackgroundDuring the coronavirus disease 2019 (COVID-19) pandemic, there is an urgent need for safe and effective COVID-19 vaccines to protect children and adolescents. This study aims to provide scientific evidence and recommendations for the application of COVID-19 vaccines in children and adolescents by analyzing the latest studies.MethodsWe systematically searched MEDLINE (accessed through PubMed), Embase, and Web of Science from January 1, 2020, to October 8, 2022. Eligible clinical trials, cohort studies, case‒control studies, and cross-sectional studies with extractable data were included in immunogenicity, effectiveness, and safety analyses. According to the heterogeneity, we chose a fixed-effect model (when I2 ≤ 50) or a random-effects model (when I2 > 50) to pool effect values.ResultsA total of 88 articles were included. The seroconversion rates after the first, second, and third doses of the vaccines were 86.10%, 96.52%, and 99.87%, respectively. After the first and second doses, vaccine effectiveness (VE) against severe acute respiratory syndrome coronavirus 2 infection was 42.87% [95% confidence interval (CI) = 27.09%-58.65%] and 63.33% (95% CI = 52.09%-74.56%), respectively. After the first and second doses, VE against COVID-19 was 60.65% (95% CI = 44.80%-76.50%) and 75.77% (95% CI = 63.99%-87.56%), respectively. VE against hospitalization due to COVID-19 after the first and second doses was 72.74% (95% CI = 51.48%-94.01%) and 82.78% (95% CI = 75.78%-89.78%), respectively. The most common adverse events were injection site pain, fatigue/asthenia/tiredness, headache, myalgia/muscle pain, and chills. The incidence rate of myocarditis or pericarditis was 2.42/100,000 people. In addition, the subgroup analysis showed that children aged ≤ 5 years had the lowest incidence of adverse events, and the incidence rate of adverse events was higher for mRNA vaccines than for inactivated vaccines.ConclusionsCOVID-19 vaccines have good immunogenicity, effectiveness, and safety among children and adolescents. We recommend that children and adolescents be vaccinated as soon as possible to protect them and slow the spread of COVID-19.

Dataset Information

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

Introduction

Methods and analysis

Publications

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

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