Maternal COVID-19 Vaccination and Lactation Outcomes

孕产妇 COVID-19 疫苗接种和哺乳结果

• 批准号: 10770308
• 负责人: Kristin Palmsten
• 金额: $ 25.03万
• 依托单位: HEALTHPARTNERS INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10770308
• 关键词: Acute; Address; Area; Award; Black Populations; Black race; Breast Feeding; Breastfed infant; COVID-19; COVID-19 complications; COVID-19 disparity; COVID-19 impact; COVID-19 vaccination; COVID-19 vaccine; Cellular Phone; Clinical Trials; Communication; Complement; Data; Data Sources; Decision Making; Development; Discipline of obstetrics; Disparity; Electronic Health Record; Eligibility Determination; English Language; Enrollment; Epidemiologic Methods; Equity; Ethnic Population; Evaluation; Exclusion; Excretory function; Funding; Future; General Population; Goals; Growth; Health Care Visit; Health system; Healthcare; High-Risk Pregnancy; Hispanic; Hispanic Populations; Human Milk; Immunization; Individual; Infant; Infant Care; Intervention; Knowledge; Lactation; Language; Licensure; Limited English Proficiency; Linguistics; Link; Maternal antibody; Methods; Milk; Minority Groups; Monitor; Mothers; National Institute of Child Health and Human Development; Nature; Not Hispanic or Latino; Observational Study; Outcome; Outcome Study; Parents; Patient Self-Report; Patients; Perinatal; Persons; Population; Positioning Attribute; Postpartum Period; Postpartum Women; Pregnancy; Pregnancy Complications; Pregnant Women; Provider; Publishing; Race; Recommendation; Reporting; Risk; Risk Estimate; SARS-CoV-2 immunity; SARS-CoV-2 infection; Safety; Sampling; Second Pregnancy Trimester; Series; System; Third Pregnancy Trimester; Trust; Vaccinated; Vaccination; Vaccines; Well Child Visits; Woman; antenatal; antibody transfer; booster vaccine; coronavirus disease; disparity reduction; ethnic disparity; health care delivery; health care service utilization; immunogenic; infant outcome; mastitis; medication safety; milk production; mortality; nonEnglish language; novel; novel strategies; preference; pregnant; programs; racial disparity; racial population; severe COVID-19; side effect; study population; surveillance study; symptomatic COVID-19; uptake; vaccine acceptance; vaccine access; vaccine distribution; vaccine hesitancy; vaccine safety; vaccine trial; volunteer

PROJECT SUMMARY (From Parent Award, R01HD107753) The efficacy of coronavirus disease (COVID-19) vaccines available in the US is up to 95% against symptomatic COVID-19. However, pregnant and lactating individuals were excluded from initial clinical trials. COVID-19 vaccine trials are now underway in pregnant women in their second or third trimester but are not expected to conclude until 2022 or 2023, and evaluation of lactation outcomes is not planned. COVID-19 vaccines are highly effective, and mounting evidence suggests immunogenic protection for breastfed infants of mothers receiving COVID-19 vaccines. To date, there are no published studies on COVID-19 vaccine safety during pregnancy or lactation for breastfed infants, milk production and excretion, or other lactation-related outcomes. This lack of safety data threatens to undermine vaccination efforts in pregnant and lactating women. Traditional data sources used for post-licensure surveillance have limited relevance for lactation outcomes. Spontaneous reporting systems suffer from reporting bias due to their voluntary nature; their lack of a denominator of vaccinated lactating women precludes risk estimates. The CDC's V-Safe program, smart phone-based monitoring for vaccine side effects, does not capture lactation status. Ongoing health care claims-based surveillance studies also do not routinely capture lactation. Observational studies enrolling COVID-vaccinated lactating women rely primarily on self-reported outcomes and have limited generalizability. To address the need for comprehensive safety data, we propose a novel study of antenatal and postpartum COVID-19 vaccination and lactation-related outcomes in mother-infant pairs, including more than 11,000 breastfeeding dyads. We will use electronic health record data linked with state immunization data across four large health systems to study infant growth, infant heath care utilization, maternal mastitis, and breastfeeding status up to 7 months after delivery following maternal COVID-19 vaccination. Also, we will explore acute infant outcomes and abnormal infant developmental screens following maternal COVID-19 vaccination. We are uniquely positioned to overcome lack of information on lactation status and reporting and volunteer bias using routinely collected information on breastfeeding at well-child visits for a defined population. We will apply rigorous epidemiologic methods, including propensity score adjustment, to address confounding. With a focus on lactation, our study will complement other studies of COVID-19 vaccination in pregnancy and studies collecting milk samples from COVID-19-vaccinated volunteers. It will provide essential and currently unavailable evidence regarding lactation-related outcomes following perinatal COVID-19 vaccination. Findings supporting safety can reduce vaccine hesitancy, whereas results identifying a potential harm will be important for informing patient decision making. Furthermore, the novel approach and methods for studying lactation related outcomes developed through the proposed study can be adapted to efficiently evaluate the safety of drugs and vaccines currently recommended or being investigated for use in pregnant or postpartum women

项目总结（来自母公司奖，R 01 HD 107753） 美国现有的冠状病毒病（COVID-19）疫苗的有效性高达95%， 症状性COVID-19。然而，妊娠和哺乳期个体被排除在初始临床试验之外。 COVID-19疫苗试验目前正在怀孕中期或晚期的孕妇中进行，但尚未 预计到2022年或2023年结束，没有计划对哺乳结果进行评估。COVID-19 疫苗非常有效，越来越多的证据表明， 接种新冠疫苗的母亲。到目前为止，还没有关于COVID-19疫苗安全性的已发表研究 母乳喂养的婴儿在怀孕或哺乳期间，乳汁的产生和排泄，或其他与哺乳有关的 结果。缺乏安全数据可能会破坏孕妇和哺乳期妇女的疫苗接种工作。 用于许可后监测的传统数据来源与哺乳结局的相关性有限。 自发报告制度因其自愿性质而存在报告偏见， 接种疫苗的哺乳期妇女的分母排除了风险估计。疾控中心的V-Safe计划很聪明 基于电话的疫苗副作用监测，不捕获哺乳状态。持续保健 基于索赔的监测研究也没有常规地记录哺乳情况。观察性研究入组 COVID疫苗接种的哺乳期妇女主要依赖于自我报告的结果，普遍性有限。 为了满足对全面安全性数据的需求，我们提出了一项新的产前和产后研究， 母婴对COVID-19疫苗接种和哺乳相关结果，包括超过11，000 母乳喂养的二人组。我们将使用电子健康记录数据与四个州的国家免疫数据相关联， 大型卫生系统研究婴儿生长、婴儿保健利用、母亲乳腺炎和母乳喂养 母亲接种COVID-19疫苗后分娩后7个月内的状态。此外，我们将探讨急性婴儿 母亲接种COVID-19疫苗后的结局和异常婴儿发育筛查。我们 独特的定位，以克服缺乏信息的哺乳状态和报告和志愿者的偏见，使用 定期在健康儿童访问中收集特定人群的母乳喂养信息。我们将应用 严格的流行病学方法，包括倾向评分调整，以解决混杂问题。 以哺乳为重点，我们的研究将补充妊娠期COVID-19疫苗接种的其他研究， 从接种COVID-19疫苗的志愿者那里收集牛奶样本的研究。它将提供必要的和目前的 关于围产期COVID-19疫苗接种后哺乳相关结局的证据不足。结果 支持安全性可以减少疫苗犹豫，而识别潜在危害的结果将是重要的 用于告知患者决策。此外，研究哺乳的新途径和方法 通过拟议的研究开发的相关结果可适用于有效地评价 目前推荐或正在研究用于孕妇或产后妇女的药物和疫苗