Inclusion of pregnant women in COVID-19 vaccine development.
Inclusion of pregnant women in COVID-19 vaccine development.
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DOI：
10.1016/s1473-3099(20)30638-1
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发表时间：
2020-09
期刊：
影响因子：
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通讯作者：
Khalil A
中科院分区：
文献类型：
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作者：
Heath PT;Le Doare K;Khalil A
2019年12月31日，武汉市卫生委员会（中国武汉）向世卫组织报告了一起肺炎病例。一种新型冠状病毒被鉴定为严重急性呼吸道综合征冠状病毒2（SARS-CoV-2），并于2020年1月宣布疫情为国际关注的突发公共卫生事件。该病毒随后在中国和全球其他国家迅速传播，并于2020年3月11日宣布爆发大流行。自2020年3月11日以来，该病毒持续传播，在许多国家造成大量发病和死亡。在以前爆发的其他冠状病毒感染，如严重急性呼吸综合征和中东呼吸综合征，严重并发症的报告在孕妇。在2009年甲型H1N1流感大流行期间，孕妇占美国死亡人数的5%，而仅占美国人口的1%。[3]然而，尽管全球报告的COVID-19病例超过1800万例，[4]对SARS-CoV-2对孕妇、胎儿和婴儿的影响的了解并不完整。一项对主要是小规模病例系列的系统性综述和荟萃分析报告称，确诊COVID-19感染的女性中有很高比例的早产（< 37周[22%]）和剖腹产（48%）。5孕妇（7%）进入重症监护室的估计比率高于非孕妇（4%），这些妇女所生婴儿中约有1.9%检测为SARS-CoV-2阳性。5到目前为止，文献集中于有症状的确诊感染妇女，然而，这可能低估了入院率，因为许多人没有症状。6许多重要问题仍未得到解答，包括无症状或轻度感染的程度以及COVID-19对流产、胎儿宫内生长受限、先天性畸形、长期生长和神经发育结果的影响。寨卡病毒感染对孕妇的影响是一个清醒的提醒，提醒孕妇病毒感染可能带来的负担。2019年，疫苗、流行病和新技术妊娠研究伦理工作组发布了一份综合文件，为孕妇和疫苗应对新出现的流行病威胁提供了准备、研究和应对方面的伦理指导。8该文件确定了一些具体战略，以促进在开发和部署针对新出现的病原体的疫苗时，在道德上负责、社会公正和尊重孕妇的利益。世卫组织科学咨询专家组欢迎这一举措，并建议将其扩大到包括哺乳期妇女。9对COVID-19疫苗的需求是无可争议的。一个特别的考虑是，对于许多正在积极考虑的候选疫苗和平台，如核酸，病毒载体和新型佐剂，尚未在孕妇中进行试验。10
On Dec 31, 2019, the Wuhan Municipal Health Commission (Wuhan, China), reported a cluster of cases of pneumonia to WHO. A novel coronavirus was identified—severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)—and the outbreak was declared as a Public Health Emergency of International Concern in January, 2020. The virus subsequently spread rapidly throughout China and other countries worldwide, and on March 11, 2020, the outbreak was declared a pandemic. Since March 11, 2020, the virus has continued to spread, causing substantial morbidity and mortality in many countries. In previous outbreaks of other coronavirus infections, such as severe acute respiratory syndrome and Middle East respiratory syndrome, serious complications were reported in pregnant women. 1, 2 During the2009 influenza A H1N1 pandemic, pregnant women accounted for 5% of US deaths, while representing only 1% of the US population. 3 However, despite more than 18 million reported cases of COVID-19 worldwide, 4 understanding of the effect of SARS-CoV-2 on pregnant women, fetuses, and infants is incomplete. A systematic review and meta-analysis of mainly small case series reported that a high proportion of women with confirmed COVID-19 infection had preterm birth (< 37 weeks [22%]) and caesarean delivery (48%). 5 Estimated rates of admission to the intensive care unit among pregnant women (7%) were higher than those of non-pregnant women (4%) and around 1· 9% of infants born to these women tested positive for SARS-CoV-2. 5 Thus far, the literature has focused on symptomatic women with confirmed infection, however, this might underestimate the rates of admission, since many individuals are asymptomatic. 6 Many important questions remain unanswered, including the extent of asymptomatic or mild infection and the effect of COVID-19 on miscarriage, intrauterine fetal growth restriction, congenital ano malies, longterm growth, and neurodevelopmental outcomes. The effects of Zika virus infection in pregnancy are a sobering reminder of the possible burden of viral infection in pregnant women. 7A comprehensive document published by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies Working Group in 2019 provided ethical guidance for preparedness, research, and response for pregnant women and vaccines against emerging epidemic threats. 8 The document identified a number of specific strategies to promote the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The WHO Scientific Advisory Group of Experts welcomed this initiative and suggested it should be extended to include lactating women. 9 The need for a vaccine against COVID-19 is indisputable. A particular consideration is that for many of the vaccine candidates and platforms being actively considered, such as nucleic acids, viral vectors, and novel adjuvants, no trials have been done in pregnant women. 10