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class="MuiTypography-root MuiTypography-body2 css-1boheuq-MuiTypography-root">疫苗的生产与研发</span></li></ol></nav></div><div class="MuiStack-root css-j9j92j-MuiStack-root" id="top"><div class="dotcom-hero-banner MuiBox-root css-7vsjpe"><div class="MuiBox-root css-0"><div class="MuiBox-root css-0"><div class="MuiContainer-root MuiContainer-maxWidthDesktop css-10rfme0-MuiContainer-root"><div class="MuiGrid2-root MuiGrid2-container MuiGrid2-direction-xs-column css-1qgmfta-MuiGrid2-root"><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-desktop-12 MuiGrid2-grid-tablet-8 MuiGrid2-grid-mobile-4 css-689yzq-MuiGrid2-root"><h1 class="MuiTypography-root MuiTypography-h1 css-1hnspsh-MuiTypography-root">疫苗的生产与研发</h1></div></div></div></div></div></div></div><div class="MuiContainer-root MuiContainer-maxWidthDesktop css-1f4kha5-MuiContainer-root"><div class="MuiStack-root css-u69w57-MuiStack-root" id="main"><div class="dotcom-content-block MuiBox-root css-gei8j6"><div class="MuiGrid2-root MuiGrid2-container MuiGrid2-direction-xs-row css-cr2kt9-MuiGrid2-root" id="51a8c838-49b0-4733-a06e-4027408516e1"><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><h2 class="MuiTypography-root MuiTypography-h2 css-1te8woh-MuiTypography-root">疫苗概要</h2></div><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><div><p class="MuiTypography-root MuiTypography-body1 css-1h3p22q-MuiTypography-root">疫苗是从活体微生物来源制成的生物制品。不同疫苗的生产时间各不相同，有的疫苗可能需要22个月才能生产出一个批次。疫苗的开发是一个漫长而复杂的过程，且成本很高。这个过程必须成功地经过几个阶段——从对相关疾病和流行病学数据的了解，到新疫苗交付至最终用户的使用。</p> <p class="MuiTypography-root MuiTypography-body1 css-sqijso-MuiTypography-root"><strong>“这不仅是一个疫苗生产的问题，还需要考虑到经济、政治以及伦理等各个方面。”</strong></p> <p class="MuiTypography-root MuiTypography-body1 css-sqijso-MuiTypography-root">——<strong>查尔斯•梅里厄博士</strong></p> </div></div></div></div><div class="dotcom-content-block MuiBox-root css-jqikz1"><div class="MuiGrid2-root MuiGrid2-container MuiGrid2-direction-xs-row css-cr2kt9-MuiGrid2-root" id="88eb5b59-f3b6-4e27-bbc1-3d9a69ea3fdc"><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><h2 class="MuiTypography-root MuiTypography-h2 css-1te8woh-MuiTypography-root">疫苗开发周期</h2></div><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><div><p class="MuiTypography-root MuiTypography-body1 css-1h3p22q-MuiTypography-root">疫苗研究是一个漫长而复杂的过程，且研究成本很高。由于疫苗是一种由活体微生物制备的生物制剂，其开发周期与药品有很大的不同。</p> <ul class="MuiTypography-root MuiTypography-body1 css-sqijso-MuiTypography-root"> <li class="MuiTypography-root MuiTypography-body1 css-1ubkcfk-MuiTypography-root">探索阶段：要了解这种疾病、掌握其流行病学数据，并找到能够预防或治疗这种疾病的相应的蛋白（抗原）。</li> <li class="MuiTypography-root MuiTypography-body1 css-1ubkcfk-MuiTypography-root">临床前期：评估抗原的安全性并选择最佳候选疫苗。</li> <li class="MuiTypography-root MuiTypography-body1 css-1ubkcfk-MuiTypography-root">临床开发：招募10人（I期）到1000人（III期）进行临床试验，生产出首批疫苗（相应的临床批次和工业批次）。</li> <li class="MuiTypography-root MuiTypography-body1 css-1ubkcfk-MuiTypography-root">注册审批：将前期收集的所有数据提交相关卫生当局审批。</li> <li class="MuiTypography-root MuiTypography-body1 css-1ubkcfk-MuiTypography-root">生产过程：最长要用22个月的时间生产一批疫苗。</li> <li class="MuiTypography-root MuiTypography-body1 css-1ubkcfk-MuiTypography-root">质量控制：大约70%的生产时间被专门用于质量控制。</li> </ul> </div></div></div></div><div class="dotcom-content-block MuiBox-root css-jqikz1"><div class="MuiGrid2-root MuiGrid2-container MuiGrid2-direction-xs-row css-cr2kt9-MuiGrid2-root" id="88e6587c-38d5-47ea-bc0c-64521b5d0d55"><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><h2 class="MuiTypography-root MuiTypography-h2 css-1te8woh-MuiTypography-root">安全性与效力</h2></div><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><div><p class="MuiTypography-root MuiTypography-body1 css-1h3p22q-MuiTypography-root">疫苗的安全性必须达到最高等级。我们的疫苗在提交卫生当局审批前，需要经过大量的试验确保其安全性和有效性。一旦投入使用，我们还要通过药物警戒体系对疫苗的安全性进行持续的监测。赛诺菲致力于向全世界提供最安全、更有效的疫苗，疫苗的开发、生产、销售既要严格遵守法规要求，又要严格依照自身价值标准。</p> </div></div></div></div><div class="dotcom-content-block MuiBox-root css-jqikz1"><div class="MuiGrid2-root MuiGrid2-container MuiGrid2-direction-xs-row css-cr2kt9-MuiGrid2-root" id="139522fe-9942-4c00-a4b4-67587203d16d"><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><h2 class="MuiTypography-root MuiTypography-h2 css-1te8woh-MuiTypography-root">疫苗药物警戒 </h2></div><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><div><h3 class="MuiTypography-root MuiTypography-h3 css-y5y3c6-MuiTypography-root">疫苗药物警戒：</h3> <p class="MuiTypography-root MuiTypography-body1 css-sqijso-MuiTypography-root">疫苗药物警戒是一项科学活动，它包括针对免疫接种后的不良反应事件或任何其他疫苗、免疫相关问题的检查、评估、了解、预防及交流。</p> <p class="MuiTypography-root MuiTypography-body1 css-sqijso-MuiTypography-root"><strong>——WHO/CIOMS疫苗药物警戒2007工作小组</strong></p> <h3 class="MuiTypography-root MuiTypography-h3 css-1xv0och-MuiTypography-root">不良反应事件（AE）：</h3> <p class="MuiTypography-root MuiTypography-body1 css-sqijso-MuiTypography-root">是指使用了某种医药产品的患者出现任何不良反应的医学事件，但这不一定与药物处置有必然的因果关系。因此，不良反应事件可以是任何不利以及不希望看到的体征（例如，实验室检测结果异常）、症状或时间上与某药物产品使用有关的疾病，无论是否被认为与该药物产品相关。</p> <p class="MuiTypography-root MuiTypography-body1 css-sqijso-MuiTypography-root"><strong>——ICH E2D步骤5，2003年11月</strong></p> <p class="MuiTypography-root MuiTypography-body1 css-sqijso-MuiTypography-root">赛诺菲疫苗建立了全球药物警戒机构，该机构依照各种标准操作规程（SOP）运作，并与各国药物警戒官紧密相连，这些药物警戒官来自于各个销售赛诺菲疫苗产品或在临床试验中使用赛诺菲疫苗产品的国家。赛诺菲疫苗从这些国家药物警戒机构获得相关通报，并按照当地要求向卫生主管部门报告不良反应事件。</p> </div></div></div></div><div class="dotcom-content-block MuiBox-root css-jqikz1"><div class="MuiGrid2-root MuiGrid2-container MuiGrid2-direction-xs-row css-cr2kt9-MuiGrid2-root" id="6cb9255a-650e-457f-b801-81019cff829e"><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><h2 class="MuiTypography-root MuiTypography-h2 css-1te8woh-MuiTypography-root">疫苗的研发</h2></div><div class="MuiGrid2-root MuiGrid2-direction-xs-row MuiGrid2-grid-mobile-4 MuiGrid2-grid-tablet-8 MuiGrid2-grid-desktop-8 css-c8gmj9-MuiGrid2-root"><div><p class="MuiTypography-root MuiTypography-body1 css-1h3p22q-MuiTypography-root">不断创新为明天创造解决方案，创新是改善全人类健康状况的关键，也是赛诺菲成功的关键。这就是公司每天投入超过100万欧元用于研究和开发的原因。开发新型疫苗的过程可长达14到25年，总成本可达3亿到10亿美元。赛诺菲在预防免疫领域一直走在最前沿。我们一如既往地利用新的科学知识和技术，设计安全有效的单剂以及联合疫苗，以预防对全球人口形成威胁的各种复杂疾病。我们通过自主研发或与第三方合作研发疫苗，应对亟待预防的疾病。</p> </div></div></div></div></div><div class="MuiStack-root css-qiso3p-MuiStack-root" id="bottom"></div></div></main><footer class="dotcom-footer"><div class="css-1n0w9uy"><div class="MuiBox-root css-1elqj97"><svg class="MuiSvgIcon-root MuiSvgIcon-fontSizeMedium css-46kbhf-MuiSvgIcon-root" focusable="false" aria-hidden="true" viewBox="0 0 80 22" xmlns="http://www.w3.org/2000/svg" width="80" height="22" fill="none" data-testid="logo" aria-label="Sanofi"><path d="M28.4057 7.29145C26.5895 6.58049 24.6556 6.21743 22.7051 6.22122C18.3338 6.22122 15.2656 9.14389 15.2656 13.7488C15.2656 18.4061 17.9277 21.2764 22.6461 21.2764C24.6249 21.2899 26.5854 20.8967 28.4057 20.1211C28.6384 20.0363 28.836 19.8762 28.9671 19.6663C29.0982 19.4563 29.1553 19.2086 29.1294 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