(2021 年 3 月 11 日) 美国新泽西州新布仑兹维克––强生(NYSE：JNJ)（以下简称“公司”）今天宣布，欧盟委员会(EC)已批准强生公司旗下杨森制药公司（以下简称“杨森”）研发的单剂量新冠肺炎疫苗的有条件上市许可（CMA），疫苗将用于 18 岁及以上成人的新冠肺炎预防。CMA遵循欧洲药品管理局(EMA)人用药品委员会(CHMP)的积极意见。2 CMA在欧盟(EU)所有27个成员国以及挪威、冰岛和列支敦士登均有效。3 期ENSEMBLE研究的数据显示，强生新冠肺炎疫苗的耐受性良好，受试者接种疫苗后有症状的新冠肺炎发生率比安慰剂组受试者减少67%。2从第14天开始观察到保护作用，并维持至接种后28天。1数据还表明，接种28天后，疫苗在所有研究区域中，对于预防重度新冠肺炎的总体保护效力为85%，并证明可预防因新冠肺炎引起的住院和死亡。1强生公司董事会主席兼首席执行官Alex Gorsky表示：“一年多来，我们夜以继日，充分调动我们全球科研人员，利用我们的规模和资源优势，研发出这一新冠肺炎疫苗。今天能够获得欧盟委员会的有条件上市许可，我们感到非常激动，这使我们的单剂量疫苗能够提供给更多有需要的群体，我们将继续竭尽所能，帮助终结这场疫情。”强生公司将致力于本着非盈利性原则提供其新冠肺炎疫苗的紧急使用。公司计划在4月下半月开始向欧盟交付单剂量新冠肺炎疫苗，在2021年对欧盟以及挪威和冰岛的供应达到2亿剂3。强生执行委员会副主席兼首席科学官Paul Stoffels博士表示：“该疫苗是我们科研人员十多年来在研发上的投入和郑重承诺的结果。我们感谢欧盟委员会在这一巨大努力中给予的合作和支持。”“凭借此次有条件上市许可，我们将通过单剂量疫苗帮助整个欧盟成员国保护其数百万民众，对此我们感到非常自豪。”2020年12月，公司宣布杨森<a class="Link " href="https://www.jnj.com/our-company/johnson-johnson-announces-initiation-of-rolling-submission-for-its-single-dose-janssen-covid-19-vaccine-candidate-with-the-european-medicines-agency" target="_blank" aria-label="启动" data-cms-ai="0">启动</a>向EMA提交单剂量新冠肺炎候选疫苗的滚动申报资料，以便加快CHMP审评程序。<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn1" target="_blank" aria-label="sup4sup" data-cms-ai="0">4</a>该疫苗也已向世界卫生组织<a class="Link " href="https://www.jnj.com/johnson-johnson-announces-submission-to-world-health-organization-for-emergency-use-listing-of-investigational-single-shot-janssen-covid-19-vaccine-candidate" target="_blank" aria-label="提交了紧急使用清单(EUL)" data-cms-ai="0">提交了紧急使用清单(EUL)</a>的申请。<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn2" target="_blank" aria-label="sup5sup" data-cms-ai="0">5</a>我们候选疫苗的滚动申报程序也已在全球多个国家启动。强生公司旗下杨森研发全球负责人 Mathai Mammen 博士表示：“包括强生团队、我们的合作伙伴和研究受试者在内，如果没有参与新冠肺炎疫苗临床试验项目中每个人的辛勤工作和奉献，这一最新的重大监管许可里程碑事件是不可能实现的”。今天的消息使我们倍感鼓舞，我们会努力为全世界人民提供单剂量新冠肺炎疫苗，并继续致力于新冠肺炎疫苗的临床项目。”在2021年2月26日美国食品药品监督管理局疫苗及相关生物制品咨询委员会<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-u-s-fda-advisory-committee" target="_blank" aria-label="一致投票通过" data-cms-ai="0">一致投票通过</a>后，<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn4" target="_blank" aria-label="sup7sup" data-cms-ai="0">7</a>强生公司于2月27日获得疫苗<a class="Link " href="https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic" target="_blank" aria-label="在美国的紧急使用授权（EUA）" data-cms-ai="0">在美国的紧急使用授权（EUA）</a>。<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn3" target="_blank" aria-label="sup6sup" data-cms-ai="0">6</a>强生公司单剂量新冠肺炎疫苗还在<a class="Link " href="https://www.jnj.com/johnson-johnson-covid-19-vaccine-granted-authorization-under-interim-order-by-health-canada-for-emergency-use" target="_blank" aria-label="加拿大" data-cms-ai="0">加拿大</a>获得了暂行法令授权。<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn5" target="_blank" aria-label="sup8sup" data-cms-ai="0">8</a>生产和供应链信息 强生公司单剂量新冠肺炎疫苗与标准疫苗储存和分销渠道相容，方便交付到偏远地区。6预计该疫苗在-25℃至-15 ℃下可保持稳定2年，在2 ℃-8 ℃常规冷藏条件下最多可稳定储存3个月。<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn6" target="_blank" aria-label="9" data-cms-ai="0">9</a>强生公司将使用与目前用于运输其他药品的相同的冷链技术运输疫苗。6强生公司新冠肺炎疫苗 强生公司的新冠肺炎疫苗利用了一种独特的专有技术<a class="Link " href="https://www.janssen.com/infectious-diseases-and-vaccines/vaccine-technology" target="_blank" aria-label="AdVacsup®sup疫苗平台" data-cms-ai="0">AdVac®疫苗平台</a>，该技术也被用于开发和生产经欧盟委员会批准的杨森埃博拉疫苗，并构建寨卡、呼吸道合胞病毒和艾滋病病毒在研候选疫苗。<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn7" target="_blank" aria-label="sup10sup" data-cms-ai="0">10</a>3期ENSEMBLE研究设计 <a class="Link " href="https://clinicaltrials.gov/ct2/show/NCT04505722" target="_blank" aria-label="3期ENSEMBLE研究" data-cms-ai="0">3期ENSEMBLE研究</a>是一项随机、双盲、安慰剂对照临床试验，<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn8" target="_blank" aria-label="sup11sup" data-cms-ai="0">11</a>旨在评估杨森候选疫苗在 18 岁及以上成年人中预防中重度新冠肺炎的安全性和保护效力，将接种 14 天和 28 天后的有效性评估作为协同主要终点。<a class="Link " href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn9" target="_blank" aria-label="sup12sup" data-cms-ai="0">12</a>该研究共入组43,783例受试者。6该试验在三大洲11的 8 个国家（地区）进行，包括多样化和广泛的人群，其中 34%的受试者超过 60 岁。1研究中 41% 的受试者患有与进展为重症新冠肺炎的风险增加相关的合并症。1如需了解更多强生启动多项计划抗击疫情的相关信息，请登录<a class="Link " href="http://www.jnj.com/coronavirus" target="_blank" aria-label="www.jnj.comcoronavirus查看" data-cms-ai="0">www.jnj.com/coronavirus查看</a>。<div class="Separator"><hr></div>关于强生公司在强生，我们坚信健康是活力人生、繁荣社区和不断进步的基础。正因如此，130 多年来，我们始终致力于推进健康事业，让人们在每个年龄段和每个人生阶段都保持健康。今天，作为一家全球业务分布广泛、综合性的跨国医疗健康企业，我们致力于用我们的广泛影响力去促进人类健康、建设更美好社会。我们努力提高医药可及性和可负担性，创造更健康的社区，让世界各地的人都能拥有健康身心，享受健康环境。我们融合关爱、科学与智慧，为人类健康事业的发展带来意义深远的改变。点击https://www.janssen.com/emea/了解更多，或通过@JanssenEMEA关注我们。关于杨森制药公司在杨森，我们努力创造一个没有疾病的未来。我们是强生的制药子公司，以科学战胜疾病，用智慧扩大准入，让关爱带来希望。我们专注于通过药物能够发挥最大作用的医学领域：心血管和代谢，免疫学，传染病和疫苗，神经科学，肿瘤学和肺动脉高压。了解更多信息请访问https://www.janssen.com/emea或通过@JanssenEMEA关注我们。关于前瞻性声明的注意事项 本新闻稿包含 1995 年美国《私人证券诉讼改革法》界定的前瞻性陈述，针对潜在的针对新冠肺炎疫苗的预防与治疗方案。本新闻稿中的前瞻性陈述基于当前对未来事件的预期，请勿依赖其中的内容。如果基本假设证明不准确或出现已知或未知的风险或不确定性，则实际结果可能与杨森制药公司和/或强生公司的预期和预测产生重大差异。风险和不确定性包括但不限于：新产品研发过程中固有的挑战，包括临床成功、获得监管部门批准以及商业化的不确定性；生产制造困难或推迟；竞争，包括技术进步、竞争对手获得的新产品和专利；专利挑战；因产品召回或监管行动导致对产品安全的担忧；医疗产品和服务采购者消费和行为的变化；适用法律法规的变更，包括全球医疗改革；医疗健康成本控制趋势的不确定性。有关这些风险、不确定性和其他因素的进一步清单和描述请查看强生公司截至 2021 年 1 月 3 日的 10-K 表财政年度报告，包括标题为“有关前瞻性陈述的说明”部分和“项目 1A 风险因素”，该公司最近提交的 10-Q 表季度报告以及该公司随后向美国证券交易委员会提交的文件。这些文件的副本可在www.sec.gov, www.jnj.com获取或向强生公司请求。杨森制药公司和强生公司均不承担根据新信息或未来事件或发展更新或修订任何前瞻性陈述的任何责任。 <div class="ArticleCredits"><ul class="ArticleCredits-items"><li class="ArticleCredits-items-item">参考文献 1. Janssen. Johnson &amp; Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial. Available at:https://www.janssen.com/emea/sites/www_janssen_com_emea/files/johnson_johnson_announces_single-shot_janssen_covid-19_vaccine_candidate_met_primary_endpoints_in_interim_analysis_of_its_phase_3_ensemble_trial.pdf. Last accessed: March 2021. 2. European Medicines Agency. EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU. Available at: https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-janssen-authorisation-eu. Last accessed: March 2021. 3. Janssen. Johnson &amp; Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate. Available at:https://www.janssen.com/emea/sites/www_janssen_com_emea/files/johnson_johnson_announces_european_commission_approval_of_agreement_to_supply_200_million_doses_of_janssens_covid-19_vaccine_candidate.pdf. Last accessed: March 2021. 4. Janssen. Johnson &amp; Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines. Available at:http://www.janssen.com/sites/www_janssen_com_emea/files/jj_announces_initiation_of_rolling_submission_for_its_single_dose_janssen_covid19_vaccine_candidate_with_the_ema.pdf. Last accessed: March 2021. 5. Janssen. Johnson &amp; Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate. Available at:https://www.janssen.com/emea/sites/www_janssen_com_emea/files/jj_announces_submission_to_who_for_eul_of_investigational_single-shot_janssen_covid-19_vaccine_candidate_.pdf. Last accessed: March 2021. 6. Johnson &amp; Johnson. Johnson &amp; Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic. Available at: https://www.jnj.com/johnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic. Last accessed: March 2021. 7. Johnson &amp; Johnson. Johnson &amp; Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee. Available at:https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-candidate-unanimously-recommended-for-emergency-use-authorization-by-u-s-fda-advisory-committee. Last accessed: March 2021. 8. Johnson &amp; Johnson. Johnson &amp; Johnson COVID-19 Vaccine Granted Authorization under Interim Order by Health Canada For Emergency Use. 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<div class="cms-textAlign-center">数据显示疫苗可预防在广泛区域内，由新冠肺炎引起的相关住院，包括新出现变异毒株的地区<a class="Link" href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn1" target="_blank" aria-label="sup1sup" data-cms-ai="0">1</a></div><div class="cms-textAlign-center">决议遵循欧洲药品管理局对强生新冠肺炎疫苗的建议<a class="Link" href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn2" target="_blank" aria-label="sup2sup" data-cms-ai="0">2</a></div><div class="cms-textAlign-center">公司计划在4月下半月开始向欧盟交付疫苗，并承诺在2021年供应将达到两亿剂<a class="Link" href="https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission#_edn3" target="_blank" aria-label="sup3sup" data-cms-ai="0">3</a></div>

强生单剂量新冠肺炎疫苗获得欧盟委员会有条件上市许可强生单剂量新冠肺炎疫苗获得欧盟委员会有条件上市许可

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强生单剂量新冠肺炎疫苗获得欧盟委员会有条件上市许可
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