Benefits and potential harms of COVID-19 vaccination during pregnancy: evidence summary for patient counseling.
Benefits and potential harms of COVID-19 vaccination during pregnancy: evidence summary for patient counseling.
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DOI：
10.1002/uog.23631
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发表时间：
2021-05
期刊：
影响因子：
--
通讯作者：
Khalil A
中科院分区：
文献类型：
--
作者：
Kalafat E;O'Brien P;Heath PT;Le Doare K;von Dadelszen P;Magee L;Ladhani S;Khalil A
从历史上看，孕妇被排除在大多数药物和疫苗试验之外，这种做法受到了科学界的广泛批评。因此，孕妇通常无法获得有益的、有时可能挽救生命的治疗和预防措施，也无法比未怀孕的同龄人得到更好的治疗和预防措施。随着妇女在发现自己怀孕或在接受治疗后不久怀孕之前接受药物或疫苗，有关怀孕期间安全性和有效性的数据随后会逐渐积累。在没有任何显著不良反应的情况下，最终建立了足够的信心（要么作为“无伤害的证据”，要么更频繁地作为“无伤害的证据”），可以考虑进行正式试验，或者，在怀孕期间使用干预措施只是进入常规实践。这种做法在2019冠状病毒病（COVID-19）疫苗中得到了重复，孕妇被排除在最初的试验之外。只有少数在不知情的情况下怀孕或在接种疫苗后不久就怀孕的妇女被纳入其中，这一队列目前正在作为原始试验的一部分进行随访。由于缺乏关于COVID-19疫苗在怀孕期间安全性的证据，国际社会倾向于采取谨慎态度，建议应根据具体情况评估孕妇的疫苗接种情况。加拿大妇产科医师学会和国际妇产科联合会是值得注意的例外，它们是妊娠期无限制接种COVID-19疫苗的早期支持者6,7。在英国，皇家妇产科学院（RCOG）建议，感染COVID-19和/或发展为严重疾病的高风险孕妇应被视为有资格接种疫苗8,9；这些标准正在不断审查中，最近于2月24日更新。所提出的危险因素来源于与COVID-19孕妇相关的文献，或从未怀孕的COVID-19妇女的数据推断出来，主要包括慢性疾病或免疫抑制疾病，以及接触病毒的高风险（表1）。应该承认，即使没有这些风险因素，妇女也可能患上严重的COVID-19。澳大利亚和新西兰皇家妇产科学院采取了与RCOG11类似的立场。美国妇产科医师学会建议，不应拒绝符合免疫实践咨询委员会建议的优先组疫苗接种标准的孕妇接种COVID-19疫苗12。在此，我们总结了现有证据，以支持对怀孕期间考虑接种COVID-19疫苗的妇女进行咨询。
Historically, pregnant women have been excluded from the majority of drug and vaccine trials, a practice that has been criticized widely by the scientific community1–3. As a result, pregnant women are routinely denied beneficial, and sometimes potentially life-saving, therapeutic and preventive measures or receive them well after their non-pregnant peers. Data about safety and efficacy in pregnancy subsequently accumulate adventitiously as women receive the drug or vaccine before finding out that they are pregnant or become pregnant soon after receiving the therapy. In the absence of any significant adverse effects, eventually sufficient confidence is established (either as ‘evidence of no harm’or, more frequently, as ‘no evidence of harm’) for a formal trial to be considered or, alternatively, the use of the intervention in pregnancy simply slips into routine practice. This practice was repeated with the coronavirus disease 2019 (COVID-19) vaccines, with pregnant women being excluded from the initial trials. Only a small number of women who were unknowingly pregnant or became pregnant soon after vaccination were included and this cohort is currently being followed up as part of the original trials4, 5. Due to lack of evidence around the safety of the COVID-19 vaccines in pregnancy, international societies have tended to take a cautious approach, recommending that vaccination of pregnant women should be evaluated on a case-by-case basis. The Society of Obstetricians and Gynaecologists of Canada and the International Federation of Gynecology and Obstetrics are notable exceptions as early endorsers of unrestricted COVID-19 vaccination in pregnancy6, 7. In the UK, the Royal College of Obstetricians and Gynaecologists (RCOG) recommends that pregnant women at high risk for contracting COVID-19 and/or developing severe illness should be considered eligible for vaccination8, 9; the criteria are under constant review and were recently updated on 24 February. The proposed risk factors are derived from literature relating specifically to pregnant women with COVID-19 or extrapolated from data on non-pregnant women with COVID-19, and consist primarily of chronic diseases or immunosuppressive conditions, as well as high risk of exposure to the virus (Table1). It should be acknowledged that women may experience severe COVID-19 even in the absence of any of these risk factors10. The Royal Australian and New Zealand College of Obstetricians and Gynaecologists has taken a stance similar to that of RCOG11. The American College of Obstetricians and Gynecologists recommends that COVID-19 vaccines should not be withheld from pregnant women who meet the criteria for vaccination based on the Advisory Committee on Immunization Practices recommended priority groups12. Here, we summarize the available evidence to support counseling of women contemplating COVID-19 vaccination during pregnancy.
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