Alignment of national COVID-19 vaccine recommendations for pregnant and lactating women.
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ABSTRACT:
SUBMITTER: Giles ML
PROVIDER: S-EPMC8477428 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: Not available
| S-EPMC7989536 | biostudies-literature
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.
| S-EPMC8120446 | biostudies-literature
Project description:AIM:To compile recommendations and evidence on the practical management of pregnant women with COVIC-19 in order to clarify standards of obstetric care in the face of this new disease. METHODS:Scoping review based on literaature searches in national and international health science databases (Pubmed/Medline, Biblioteca virtual en salud (BVS), Scielo, COCHRANE and CUIDEN) and websites, and additionally by a "snowball" system. MeSH terms were used: "COVID-19", "Pregnancy", "Delivery, Obstetric" "Pregnant Women" and "Maternal". As limits in the search Spanish and English languages were selected. No limits were established in relation to the year of publication or type of article. RESULTS:A total of 49 documents and articles were detected, of which 27 were analyzed, 18 were used, and 9 were discarded because they did not contain practical recommendations. The recommendations were grouped into 9 subjects: Prevention of infection in pregnant women, Prevention of infection in health care personnel attending pregnant women, Form of presentation and severity in pregnant women, Maternal-fetal transmission (vertical and perinatal), Maternal-fetal control of the pregnant woman infected with COVID-19, Control of the severely pregnant woman with COVID-19, Treatment of the pregnant woman with COVID-19, Management and route of termination of labor, Neonatal outcomes in women with COVID-19 and Breastfeeding. CONCLUSIONS:Lack of strong evidence to support many of the recommendations for pregnant women with COVID-19, as they are based on previous experience with SARS-CoV and MERS-CoV infections. Further studies are needed to confirm the appropriateness of many of the recommendations and guidelines for action in the specific case of pregnant women and COVIC-19.
| S-EPMC7231730 | biostudies-literature
Project description:BackgroundPregnant and lactating women were excluded from initial coronavirus disease 2019 vaccine trials; thus, data to guide vaccine decision making are lacking.ObjectiveThis study aimed to evaluate the immunogenicity and reactogenicity of coronavirus disease 2019 messenger RNA vaccination in pregnant and lactating women compared with: (1) nonpregnant controls and (2) natural coronavirus disease 2019 infection in pregnancy.Study designA total of 131 reproductive-age vaccine recipients (84 pregnant, 31 lactating, and 16 nonpregnant women) were enrolled in a prospective cohort study at 2 academic medical centers. Titers of severe acute respiratory syndrome coronavirus 2 spike and receptor-binding domain immunoglobulin G, immunoglobulin A, and immunoglobulin M were quantified in participant sera (n=131) and breastmilk (n=31) at baseline, at the second vaccine dose, at 2 to 6 weeks after the second vaccine, and at delivery by Luminex. Umbilical cord sera (n=10) titers were assessed at delivery. Titers were compared with those of pregnant women 4 to 12 weeks from the natural infection (n=37) by enzyme-linked immunosorbent assay. A pseudovirus neutralization assay was used to quantify neutralizing antibody titers for the subset of women who delivered during the study period. Postvaccination symptoms were assessed via questionnaire. Kruskal-Wallis tests and a mixed-effects model, with correction for multiple comparisons, were used to assess differences among groups.ResultsVaccine-induced antibody titers were equivalent in pregnant and lactating compared with nonpregnant women (pregnant, median, 5.59; interquartile range, 4.68-5.89; lactating, median, 5.74; interquartile range, 5.06-6.22; nonpregnant, median, 5.62; interquartile range, 4.77-5.98, P=.24). All titers were significantly higher than those induced by severe acute respiratory syndrome coronavirus 2 infection during pregnancy (P<.0001). Vaccine-generated antibodies were present in all umbilical cord blood and breastmilk samples. Neutralizing antibody titers were lower in umbilical cord than maternal sera, although this finding did not achieve statistical significance (maternal sera, median, 104.7; interquartile range, 61.2-188.2; cord sera, median, 52.3; interquartile range, 11.7-69.6; P=.05). The second vaccine dose (boost dose) increased severe acute respiratory syndrome coronavirus 2-specific immunoglobulin G, but not immunoglobulin A, in maternal blood and breastmilk. No differences were noted in reactogenicity across the groups.ConclusionCoronavirus disease 2019 messenger RNA vaccines generated robust humoral immunity in pregnant and lactating women, with immunogenicity and reactogenicity similar to that observed in nonpregnant women. Vaccine-induced immune responses were statistically significantly greater than the response to natural infection. Immune transfer to neonates occurred via placenta and breastmilk.
| S-EPMC7997025 | biostudies-literature
Project description:BackgroundAlthough mass vaccination against COVID-19 may prove to be the most efficacious end to this deadly pandemic, there remain concern and indecision among the public toward vaccination. Because pregnant and reproductive-aged women account for a large proportion of the population with particular concerns regarding vaccination against COVID-19, this survey aimed at investigating their current attitudes and beliefs within our own institution.ObjectiveThis study aimed to understand vaccine acceptability among pregnant, nonpregnant, and breastfeeding respondents and elucidate factors associated with COVID-19 vaccine acceptance.Study designWe administered an anonymous online survey to all women (including patients, providers, and staff) at our institution assessing rates of acceptance of COVID-19 vaccination. Respondents were contacted in 1 of 3 ways: by email, advertisement flyers, and distribution of quick response codes at virtual town halls regarding the COVID-19 vaccine. Based on their responses, respondents were divided into 3 mutually exclusive groups: (1) nonpregnant respondents, (2) pregnant respondents, and (3) breastfeeding respondents. The primary outcome was acceptance of vaccination. Prevalence ratios were calculated to ascertain the independent effects of multiple patient-level factors on vaccine acceptability.ResultsThe survey was administered from January 7, 2021, to January 29, 2021, with 1012 respondents of whom 466 (46.9%) identified as non-Hispanic White, 108 (10.9%) as non-Hispanic Black, 286 (28.8%) as Hispanic, and 82 (8.2%) as non-Hispanic Asian. The median age was 36 years (interquartile range, 25-47 years). Of all the respondents, 656 respondents (64.8%) were nonpregnant, 216 (21.3%) were pregnant, and 122 (12.1%) were breastfeeding. There was no difference in chronic comorbidities when evaluated as a composite variable (Table 1). A total of 390 respondents (39.2%) reported working in healthcare. Nonpregnant respondents were most likely to accept vaccination (457 respondents, 76.2%; P<.001) with breastfeeding respondents the second most likely (55.2%). Pregnant respondents had the lowest rate of vaccine acceptance (44.3%; P<.001). Prevalence ratios revealed all non-White races except for non-Hispanic Asian respondents, and Spanish-speaking respondents were less likely to accept vaccination (Table 3). Working in healthcare was not found to be associated with vaccine acceptance among our cohort.ConclusionIn this survey study of only women at a single institution, pregnant respondents of non-White or non-Asian races were more likely to decline vaccination than nonpregnant and breastfeeding respondents. Working in healthcare was not associated with vaccine acceptance.
| S-EPMC8146275 | biostudies-literature
Project description:IntroductionThe pandemic of COVID-19 disease has caused severe impact globally. Governments consider vaccination as an effective measure to control pandemic. However, many people have been hesitant to receive COVID-19 vaccine, particularly periconceptional and lactating women. Although research has indicated that pregnant women with COVID-19 are at a higher risk of adverse pregnancy and birth outcomes, as well as severe illness. There appears to be a lack of systematic and comprehensive evidence of the prevalence and determinants of COVID-19 vaccine hesitancy among periconceptional and lactating women. As a result, it has been essential to investigate periconceptional and lactating women's vaccination views and behaviours. This study will review articles on vaccine hesitancy among periconceptional and lactating women to assess the impact of the COVID-19 vaccine hesitancy during the pandemic.Methods and analysisWe will systematically search observational studies from 1 November 2019 to 30 October 2021 in the following databases: Web of Science, PubMed, EMBASE, MEDLINE, Cochrane Library, EBSCO, WHO COVID-19 Database, CNKI and WanFang Database. The following medical subject headings and free-text terms will be used: "COVID-19 vaccines" AND "female" AND "vaccine hesitancy". Eligibility criteria are as follows: population (women of reproductive age); exposure (currently pregnant, lactational or trying to get pregnant); comparison (general women who are not in preconception, gestation or lactation) and outcome (the rate of COVID-19 vaccine hesitancy). Article screening and data extraction will be undertaken independently by two reviewers, and any discrepancy will be resolved through discussion. We will use I2 statistics to assess heterogeneity and perform a meta-analysis when sufficiently homogeneous studies are provided. We will explore the potential sources of heterogeneity using subgroup and meta-regression analysis.Ethics and disseminationThis study will use published data, so ethical approval is not required. The findings will be disseminated by publication in peer-reviewed journal(s).Prospero registration numberCRD42021257511.
| S-EPMC9644077 | biostudies-literature
Project description: Not available
| S-EPMC8220929 | biostudies-literature
Project description:IntroductionConcerns about SARS-CoV-2 infection risk in health care settings have resulted in changes in prenatal care and birth plans, such as shifts to in-person visits and increased Cesarean delivery. These changes may affect quality of care and limit opportunities for clinicians to counsel pregnant individuals, who are at higher risk of severe COVID-19 disease and adverse pregnancy outcomes, about prevention and vaccination.MethodsWe conducted a cross-sectional online survey of United States adults on changes in prenatal care, COVID-19 vaccine willingness, and reasons for unwillingness to receive a vaccine. We summarized changes in access to care and examined differences in vaccine willingness between pregnant and propensity-score matched non-pregnant controls using chi-squared tests and multivariable conditional logistic regression.ResultsBetween December 15-23, 2020, 8481 participants completed the survey, of which 233 were pregnant. Three-quarters of pregnant women (n = 186) experienced a change in prenatal care, including format of care (n = 84, 35%) and reduced visits (n = 69, 24%). Two-thirds experienced a change in birth plans, from a hospital birth to home birth (n = 45, 18%) or vaginal birth to a Cesarean delivery (n = 42, 17%). Although 40% of pregnant women (n = 78) were unwilling to receive COVID-19 vaccination, they had higher, though non-significant, odds of reporting willingness to receive vaccination compared to similar non-pregnant women (aOR 1.38, 95% CI: 0.95, 2.00).ConclusionTo support pregnant women through the perinatal care continuum, maternity care teams should develop protocols to foster social support, patient-centered education around infection prevention that focuses on improved risk perception, expected changes in care due to COVID-19, and vaccine effectiveness and safety.
| S-EPMC9281008 | biostudies-literature
Project description:ObjectivesThe purpose of this study is to examine the effects of coronavirus disease 2019 pandemic on the prevalence of anxiety, depression, stress, insomnia, and social dysfunction among pregnant and/or lactating women and to measure the global pooled prevalence of mental health effects among these populations in the era of coronavirus disease 2019 pandemic.MethodsComprehensive literature searching was conducted and studies published from 1 January 2020 to 30 September 2020 reporting the prevalence of anxiety, depression; stress, insomnia, and social dysfunctions were included. The pooled prevalence of anxiety, depression, stress, insomnia, and social dysfunctions was estimated using a random-effect model. In this study, all statistical analyses were performed using STATA (version 15) software.ResultsThere were a total of 19 studies included in the meta-analysis, of which 16, 14, 4, 2, and 2 studies were included in computing the pooled prevalence of anxiety, depression, stress, insomnia, and social dysfunction, respectively. The pooled prevalence of anxiety was 33% (95% confidence interval: 50%-61%), with significant heterogeneity between studies (I2 = 99.68%, p = 0.001). The pooled prevalence of depression was 27% (95% confidence interval: 9%-45%), with remarkable heterogeneity between studies (I2 = 99.29%, p = 0.001). Likewise, the pooled prevalence of stress was 56% (95% confidence interval: 30.07%-82.22%), with significant heterogeneity between studies (I2 = 98.8%, p = 0.0001). The pooled prevalence of social dysfunction was 24.3% (95% confidence interval: 13.41%-62.03%), with significant heterogeneity between studies (I2 = 97.5%, p = 0.0001) and finally, the pooled prevalence of insomnia was 33.53% (95% confidence interval: 3.05%-64.0%), with significant heterogeneity between studies (I2 = 99.6%, p = 0.0001).ConclusionsIn this study, the mental health effects of the COVID-19 pandemic among pregnant and lactating women were found to be significant. Stress was the most common mental health problem in these population groups. Therefore, policymakers and health planners should give great emphasis to addressing maternal mental well-being during and after this global health crisis. Maternal mental health must be one of the international and national public health priority agendas to enhance the well-being of pregnant and lactating women. Besides, giving psychological support to pregnant and lactating women may reduce the long-term negative effects of this pandemic.
| S-EPMC8243107 | biostudies-literature
Project description:The 2019 novel coronavirus disease (COVID-19), which is caused by the novel beta coronavirus, SARS-CoV-2, is currently prevalent all over the world, causing thousands of deaths with relatively high virulence. Like two other notable beta coronaviruses, severe acute respiratory syndrome coronavirus-1 (SARS-CoV-1) and Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV-2 can lead to severe contagious respiratory disease. Due to impaired cellular immunity and physiological changes, pregnant women are susceptible to respiratory disease and are more likely to develop severe pneumonia. Given the prevalence of COVID-19, it is speculated that some pregnant women have already been infected. However, limited data are available for the clinical course and management of COVID-19 in pregnancy. Therefore, we conducted this review to identify strategies for the obstetric management of COVID-19. We compared the clinical course and outcomes of COVID-19, SARS, and MERS in pregnancy and discussed several drugs for the treatment of COVID-19 in pregnancy.
| S-EPMC7264107 | biostudies-literature