Maternal COVID-19 Vaccination and Lactation Outcomes

孕产妇 COVID-19 疫苗接种和哺乳结果

• 批准号: 10390754
• 负责人: Kristin Palmsten
• 金额: $ 61.9万
• 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/10390754
• 关键词: Acute; Address; Age-Months; Biological; Body Composition; Breast Feeding; Breastfed infant; COVID-19; COVID-19 impact; COVID-19 vaccination; COVID-19 vaccine; Caring; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Trials; Complement; Cytomegalovirus; Data; Data Sources; Decision Making; Dehydration; Development; Discipline of obstetrics; Dose; Electronic Health Record; Enrollment; Epidemiologic Methods; Evaluation; Excretory function; Fatigue; Fever; Frequencies; Growth; Guidelines; Health system; Healthcare; Human; Human Milk; Icterus; Immunization; Individual; Infant; Inflammatory Response; Influenza; Lactation; Licensure; Link; Malaise; Methods; Milk; Monitor; Mothers; Nature; Observational Study; Outcome; Patient Self-Report; Patients; Perinatal; Population; Positioning Attribute; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Professional Organizations; Publishing; RNA vaccine; Reporting; Respiratory syncytial virus; Risk; Risk Estimate; Safety; Sampling; Screening Result; Second Pregnancy Trimester; Surveys; System; Third Pregnancy Trimester; Vaccinated; Vaccination; Vaccines; Viral Proteins; Viral Vector; Well Child Visits; Woman; antenatal; base; coronavirus disease; cytokine; health care delivery; health care service utilization; immunogenic; infant outcome; mastitis; medication safety; milk production; novel; novel strategies; perinatal period; pregnant; programs; side effect; surveillance study; symptomatic COVID-19; vaccine access; vaccine hesitancy; vaccine safety; vaccine trial; volunteer

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.

冠状病毒病（COVID-19）疫苗的效率在美国可获得95％的疫苗，而有症状的Covid-19。但是，将怀孕和哺乳的个体排除在初始临床试验之外。孕妇的第二或第三个孕妇目前正在进行疫苗试验，但预计要等到2022年或2023年才包括在内，并且不计划评估哺乳结果。 Covid-19-19疫苗非常有效，越来越多的证据表明，接受Covid-19疫苗的母亲的母乳喂养婴儿的免疫原性保护。迄今为止，尚无关于妊娠或哺乳期在母乳喂养，牛奶生产和极端或其他与泌乳相关的结局的疫苗安全性的公开研究。缺乏安全数据有可能破坏孕妇和哺乳期妇女的疫苗努力。用于许可后监视的传统数据源与哺乳结果的相关性有限。自发报告系统由于其自愿性而遭受报告偏见；他们缺乏疫苗接种的哺乳期妇女的分母排除了风险估计。疾病预防控制中心的V-SAFE程序，基于智能电话的疫苗副作用监测，无法捕获哺乳状态。正在进行的基于医疗索赔的监视研究也不常规地捕获泌乳。招募共vid杀菌哺乳动物的妇女的观察性研究主要依赖于自我报告的结果，并且具有有限的普遍性。为了满足对全面安全数据的需求，我们提出了一项针对母亲对抗触角和产后疫苗的新研究，以及与母亲成对的与泌乳相关的结果，包括超过11,000多个母乳喂养二元组。我们将使用与四个大型卫生系统中的州免疫数据相关的电子健康记录数据来研究婴儿的生长，婴儿卫生护理利用，母乳乳腺炎和母乳喂养状态，最多可长达7个月。此外，我们将探索Mater Covid-19疫苗后的急性婴儿结局和异常的婴儿发育筛查。我们的位置是克服缺乏有关哺乳状况以及报告和志愿者偏见的信息，并使用经常收集的有关定义人群的孩子访问时进行母乳喂养的信息。我们将采用严格的流行病学方法，包括承诺得分调整，以解决混杂问题。以哺乳为重点，我们的研究将补充其他关于妊娠的Covid-19疫苗的研究，并研究从共vid-19-19种接种志愿者那里收集牛奶样品。它将提供有关围产期Covid-19疫苗后与泌乳相关的结果的必要且目前无法获得的证据。支持安全性的发现可以减少疫苗的犹豫，而确定潜在伤害的结果对于告知患者决策至关重要。此外，可以对通过拟议研究开发的哺乳期与结局的新方法和方法进行调整，以有效评估目前建议或研究用于孕妇或产后妇女的药物和疫苗的安全性。