Equity in coronavirus disease 2019 vaccine development and deployment.
Equity in coronavirus disease 2019 vaccine development and deployment.
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DOI：
10.1016/j.ajog.2021.01.006
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发表时间：
2021-05
影响因子：
9.8
通讯作者：
Voto L
中科院分区：
文献类型：
--
作者：
Modi N;Ayres-de-Campos D;Bancalari E;Benders M;Briana D;Di Renzo GC;Fonseca EB;Hod M;Poon L;Cortes MS;Simeoni U;Tscherning C;Vento M;Visser GHA;Voto L
2019年冠状病毒大流行暴露了多个领域的弱点，并扩大了世界各地基于性别的不平等。它还在不到一年的时间里将疫苗带给了公众，促进了非凡的科学成就。在这篇文章中，我们讨论了当前疫苗接种指南对孕妇和哺乳期妇女的影响，如果她们被排除在第一波疫苗试验之外是合理的，以及是否有必要改变目前的疫苗开发途径。孕妇和哺乳期妇女没有包括在最初的严重急性呼吸综合征冠状病毒2型疫苗试验中。因此，也许并不令人惊讶的是，第一批疫苗监管批准伴随着来自世界各地公共卫生、政府和专业当局的不一致建议。拒绝为那些尽管怀孕或哺乳但完全有能力自主决策的女性接种疫苗，是对家长式时代的倒退。相反，缺乏及时产生的证据，从而做出明智的决定，就会将责任从研究赞助商和监管机构转移到妇女和她的医疗顾问身上，并将决策的负担放在妇女和她的医疗顾问身上。世界卫生组织、专门针对孕妇和哺乳期妇女的研究工作队和其他机构强调了妇女在疫苗和药物开发方面长期处于的不利地位。目前还不确定是否有足够的理由将孕妇和哺乳期妇女排除在最初的严重急性呼吸综合征冠状病毒2型疫苗试验之外。未来，我们建议监管机构制定计划，描述满足怀孕或哺乳期妇女需求的新疫苗和药物的开发途径。这些措施应在一开始就包括仔细考虑被排除在初始研究之外或纳入初始研究的风险的平衡、患者和公众的观点、“发育和生殖毒性”研究的细节，以及从接触时不知情的参与者那里系统地收集数据的方法。这需要仔细考虑任何先前关于疫苗作用模式和毒性或致畸可能性的知识。我们还支持这样一种观点，即默认立场应该是“纳入推定”，只有在基于特定而不是一般的理由有正当理由的情况下，才将怀孕或哺乳期妇女排除在外。最后，我们建议各国加强协调，目的是发布一致的公共卫生建议。
The coronavirus disease 2019 pandemic exposed weaknesses in multiple domains and widened gender-based inequalities across the world. It also stimulated extraordinary scientific achievement by bringing vaccines to the public in less than a year. In this article, we discuss the implications of current vaccination guidance for pregnant and lactating women, if their exclusion from the first wave of vaccine trials was justified, and if a change in the current vaccine development pathway is necessary. Pregnant and lactating women were not included in the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. Therefore, perhaps unsurprisingly, the first vaccine regulatory approvals have been accompanied by inconsistent advice from public health, governmental, and professional authorities around the world. Denying vaccination to women who, although pregnant or breastfeeding, are fully capable of autonomous decision making is a throwback to a paternalistic era. Conversely, lack of evidence generated in a timely manner, upon which to make an informed decision, shifts responsibility from research sponsors and regulators and places the burden of decision making upon the woman and her healthcare advisor. The World Health Organization, the Task Force on Research Specific to Pregnant Women and Lactating Women, and others have highlighted the long-standing disadvantage experienced by women in relation to the development of vaccines and medicines. It is uncertain whether there was sufficient justification for excluding pregnant and lactating women from the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. In future, we recommend that regulators mandate plans that describe the development pathway for new vaccines and medicines that address the needs of women who are pregnant or lactating. These should incorporate, at the outset, a careful consideration of the balance of the risks of exclusion from or inclusion in initial studies, patient and public perspectives, details of “developmental and reproductive toxicity” studies, and approaches to collect data systematically from participants who are unknowingly pregnant at the time of exposure. This requires careful consideration of any previous knowledge about the mode of action of the vaccine and the likelihood of toxicity or teratogenicity. We also support the view that the default position should be a “presumption of inclusion,” with exclusion of women who are pregnant or lactating only if justified on specific, not generic, grounds. Finally, we recommend closer coordination across countries with the aim of issuing consistent public health advice.
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DOI：
10.15585/mmwr.mm6944e3
发表时间：
2020-11-06
期刊：
MMWR. Morbidity and mortality weekly report
影响因子：
--
作者：
Zambrano LD;Ellington S;Strid P;Galang RR;Oduyebo T;Tong VT;Woodworth KR;Nahabedian JF 3rd;Azziz-Baumgartner E;Gilboa SM;Meaney-Delman D;CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team
通讯作者：
CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team
影响因子：
64.8
作者：
Arvin, Ann M.;Fink, Katja;Virgin, Herbert W.
通讯作者：
Virgin, Herbert W.
影响因子：
9.8
作者：
Lamouroux, Audrey;Attie-Bitach, Tania;Ville, Yves
通讯作者：
Ville, Yves
影响因子：
7.7
作者：
Pique-Regi, Roger;Romero, Roberto;Gomez-Lopez, Nardhy
通讯作者：
Gomez-Lopez, Nardhy
影响因子：
16.6
作者：
Vivanti, Alexandre J.;Vauloup-Fellous, Christelle;De Luca, Daniele
通讯作者：
De Luca, Daniele