2019冠状病毒病（COVID-19）疫苗接种与自然流产
Coronavirus Disease 2019 (COVID-19) Vaccination and Spontaneous Abortion.
作者信息
Sheth Sangini S, Vazquez-Benitez Gabriela, DeSilva Malini B, Zhu Jingyi, Seburg Elisabeth M, Denoble Anna E, Daley Matthew F, Getahun Darios, Klein Nicola P, Vesco Kimberly K, Irving Stephanie A, Nelson Jennifer C, Williams Joshua T B, Hambidge Simon J, Donahue James G, Lipkind Heather S, Kharbanda Elyse O
机构信息
Yale School of Medicine, New Haven, Connecticut; HealthPartners Institute, Bloomington, Minnesota; the Institute for Health Research, Kaiser Permanente Colorado, and Ambulatory Care Services, Denver Health, Denver, Colorado; Kaiser Permanente Southern California, Pasadena, and Kaiser Permanente Vaccine Study Center, Oakland, California; Kaiser Permanente Center for Health Research, Portland, Oregon; Kaiser Permanente Washington Health Research Institute, Seattle, Washington; Marshfield Clinic Research Institute, Marshfield, Wisconsin; the Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia; and Weill-Cornell School of Medicine, New York, New York.
出版信息
Obstet Gynecol. 2025 May 2;146(1):129-137. doi: 10.1097/AOG.0000000000005904.
OBJECTIVE
To examine the association between coronavirus disease 2019 (COVID-19) vaccination and spontaneous abortion.
METHODS
We conducted a case-control study of clinically adjudicated spontaneous abortions (case group) occurring between January 19, 2021, and October 27, 2021, and live births (control group). Patients aged 16-49 years at eight Vaccine Safety Datalink sites who had singleton pregnancies, one or more prenatal visits, continuous health plan enrollment, and spontaneous abortion (fetal loss between 6 and less than 20 weeks of gestation) or live birth were eligible. A random sample of eligible patients with spontaneous abortions was adjudicated to confirm pregnancy outcome, outcome date, and gestational age at fetal death; patients in the adjudicated spontaneous abortion case group were matched 1:2 on Vaccine Safety Datalink site, maternal age, and pregnancy start date with eligible patients with live births. Vaccine exposure was considered from pregnancy start to spontaneous abortion date or equivalent gestational age for the matched live births (index date). Conditional logistic regression was used to evaluate the association between COVID-19 vaccination in pregnancy and spontaneous abortion; secondary analyses explored associations by dose number, vaccine manufacturer, and vaccination within 6 weeks of the spontaneous abortion.
RESULTS
Matched analyses included 296 patients in the spontaneous abortion case group and 592 in the live birth control group. There was no association between spontaneous abortion and COVID-19 vaccination (adjusted odds ratio [aOR] 0.85, 95% CI, 0.56-1.30). There was also no association between spontaneous abortion and dose number compared with no vaccine (one dose: aOR 0.81, 95% CI, 0.39-1.70; two doses: aOR 0.84, 95% CI, 0.51-1.38; vaccine manufacturer: Moderna aOR 0.59, 95% CI, 0.29-1.19 and Pfizer-BioNTech aOR 0.97, 95% CI, 0.57-1.66; or vaccine exposure window of 6 weeks before spontaneous abortion or index date: aOR 0.87, 95% CI, 0.53-1.44).
CONCLUSION
There was no observed association between COVID-19 vaccination in pregnancy and spontaneous abortion. Findings support the safety of COVID-19 vaccination in early pregnancy.
目的
研究2019冠状病毒病（COVID-19）疫苗接种与自然流产之间的关联。
方法
我们开展了一项病例对照研究，纳入2021年1月19日至2021年10月27日期间经临床判定的自然流产病例（病例组）和活产病例（对照组）。在八个疫苗安全数据链站点，年龄在16至49岁之间、单胎妊娠、有一次或多次产前检查、持续参加健康计划且发生自然流产（妊娠6周至不足20周的胎儿丢失）或活产的患者符合条件。对符合条件的自然流产患者进行随机抽样，以确认妊娠结局、结局日期和胎儿死亡时的孕周；经判定的自然流产病例组患者在疫苗安全数据链站点、母亲年龄和妊娠开始日期方面与符合条件的活产患者按1:2进行匹配。疫苗暴露时间从妊娠开始至自然流产日期或匹配活产的等效孕周（索引日期）。采用条件逻辑回归评估孕期COVID-19疫苗接种与自然流产之间的关联；二次分析按剂量数、疫苗制造商以及自然流产前6周内的疫苗接种情况探索关联。
结果
匹配分析纳入了296例自然流产病例组患者和592例活产对照组患者。自然流产与COVID-19疫苗接种之间无关联（调整优势比[aOR]为0.85，95%置信区间[CI]为0.56 - 1.30）。与未接种疫苗相比，自然流产与剂量数之间也无关联（一剂：aOR为0.81，95% CI为0.39 - 1.70；两剂：aOR为0.84，95% CI为0.51 - 1.38；疫苗制造商：Moderna的aOR为0.59，95% CI为0.29 - 1.19，辉瑞 - 生物科技公司的aOR为0.97，95% CI为0.57 - 1.66；或自然流产或索引日期前6周的疫苗暴露窗口：aOR为0.87，95% CI为0.53 - 1.44）。
结论
未观察到孕期COVID-19疫苗接种与自然流产之间存在关联。研究结果支持孕期接种COVID-19疫苗的安全性。
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