Uptake, Safety and Effectiveness of COVID‐19 Vaccines during Pregnancy

怀孕期间 COVID-19 疫苗的服用、安全性和有效性

• 批准号: 10605314
• 负责人: Annette Karena Regan
• 金额: $ 38.33万
• 依托单位: UNIVERSITY OF SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-08 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10605314
• 关键词: 2019-nCoV; Admission activity; Advisory Committees; Age; American College of Obstetricians and Gynecologists; Anxiety; COVID-19; COVID-19 diagnosis; COVID-19 impact; COVID-19 vaccination; COVID-19 vaccine; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Clinical Trials; Cohort Studies; Computerized Medical Record; Data; Databases; Decision Making; Discipline of obstetrics; Disease; Effectiveness; Electronic Health Record; Eligibility Determination; Emergency Situation; Ensure; Epidemiology; Event; Exclusion; FDA Emergency Use Authorization; Fetal health; Goals; Guidelines; Health; Health Personnel; Immunization; Individual; Infant; Infant Health; Infection; Intensive Care; Intention; Learning; Link; Maternal Health; Mechanical ventilation; Medical; Mothers; Nature; Observational Study; Outcome; Participant; Passive Immunity; Perinatal; Perinatal mortality demographics; Persons; Phase; Phase II/III Clinical Trial; Phase III Clinical Trials; Planned Pregnancy; Policies; Policy Making; Population; Population Group; Pregnancy; Pregnancy loss; Premature Birth; Probability; Public Health; Recommendation; Reporting; Research; Risk; Risk Factors; SARS-CoV-2 exposure; SARS-CoV-2 infection; Safety; Special Event; Surveys; System; Time; Update; Vaccinated; Vaccination; Vaccines; Woman; adverse outcome; adverse pregnancy outcome; care providers; experience; fetal; high risk; implementation evaluation; influenza virus vaccine; interest; maternal outcome; neonatal health; neonatal outcome; neonate; new technology; policy implication; policy recommendation; post SARS-CoV-2 infection; post implementation; pregnant; prevent; programs; reproductive; severe COVID-19; sociodemographics; systematic review; unvaccinated; uptake; vaccination outcome; vaccination strategy; vaccine acceptance; vaccine safety; variants of concern

PROJECT SUMMARY Pregnant persons are at increased risk for severe COVD-19 illness compared to non-pregnant women of reproductive age, experiencing higher rates of admission to intensive care, mechanical ventilation and death. In addition to the direct impacts on the health of pregnant persons, there is growing evidence to suggest COVID-19 adversely impacts fetal and neonatal health. As of May 2021, three vaccines have been issued Emergency Use Approval in the US. However, because pregnant persons were excluded from initial Phase 3 clinical trials, data to confirm the safety and effectiveness of COVID-19 vaccination during pregnancy are lacking. Driven by this limited data, obstetric and public health governing bodies do not currently directly recommend vaccination for pregnant persons. The American College of Obstetricians and Gynecologists and the US Centers for Disease Control and Prevention (CDC) advise that COVID-19 vaccines should not be withheld from pregnant persons. As a result, the decision to vaccinate is made at the individual level, and pregnant persons express anxiety around making this decision. Additional data to inform the safety and effectiveness of COVID-19 vaccines administered during pregnancy would strengthen current clinical guidelines. Despite weak guidance, individuals are choosing to be vaccinated during pregnancy. As of 3 May 2021, 106,241 pregnant persons were reported as having received a COVID-19 vaccine through V-SAFE, the CDC’s active vaccine safety surveillance system. When surveyed, more than 50% of pregnant persons report an intention to receive a COVID-19 vaccine. Phase 2/3 clinical trial data are currently being gathered to evaluate safety and efficacy. While these clinical trial data are being collected, we have the opportunity to learn from large observational studies of pregnant persons who have chosen to be vaccinated. Leveraging existing national medical claims and electronic medical records for more than 870,000 pregnancies, we plan to conduct large-scale post-implementation cohort studies to evaluate the uptake, safety and effectiveness of COVID-19 vaccines administered during pregnancy. Completion of the proposed research will provide important epidemiological evidence on the safety and effectiveness of COVID-19 vaccination during pregnancy. This evidence will aid informed decision and policy-making around COVID-19 vaccination for pregnant persons.

项目摘要 与非孕妇相比，孕妇患严重COVD-19疾病的风险增加 育龄妇女接受重症监护的比例较高， 机械通气和死亡除了对孕妇健康的直接影响外， 越来越多的证据表明，COVID-19对胎儿和新生儿产生了不利影响。 健康截至2021年5月，三种疫苗已在美国获得紧急使用批准。 然而，由于妊娠者被排除在最初的3期临床试验之外， 确认在怀孕期间接种COVID-19疫苗的安全性和有效性不足。 在这一有限数据的推动下，产科和公共卫生管理机构目前没有直接 建议孕妇接种疫苗。美国妇产科医师学会 妇科医生和美国疾病控制和预防中心（CDC）建议， 孕妇不应拒绝接种COVID-19疫苗。因此，决定 接种疫苗是在个人层面进行的，孕妇对接种疫苗感到焦虑， 这个决定。更多的数据，以告知COVID-19疫苗的安全性和有效性 在怀孕期间使用，将加强目前的临床指南。 尽管缺乏指导，但人们选择在怀孕期间接种疫苗。月3日 2021年5月，106，241名孕妇被报告接种了COVID-19疫苗 通过V-SAFE，CDC的主动疫苗安全监测系统。调查显示，更多 超过50%的孕妇表示有意接种COVID-19疫苗。2/3期 目前正在收集临床试验数据以评估安全性和有效性。虽然这些 正在收集临床试验数据，我们有机会从大型观察性研究中学习， 对选择接种疫苗的孕妇进行的研究。 利用现有的国家医疗索赔和电子医疗记录， 870，000例妊娠，我们计划进行大规模的实施后队列研究， 评估接种期间接种的COVID-19疫苗的吸收、安全性和有效性 怀孕完成拟议的研究将提供重要的流行病学资料， 怀孕期间接种COVID-19疫苗的安全性和有效性的证据。这 证据将有助于围绕COVID-19疫苗接种做出明智的决定和政策制定， 孕妇。