世卫将SINOVAC科兴新冠疫苗克尔来福 ® 推荐使用年龄扩展至3岁及以上

近日，世界卫生组织（WHO）已将SINOVAC科兴新冠疫苗克尔来福 ® 推荐使用年龄扩展至3岁及以上 1 ，克尔来福 ® 成为世界卫生组织紧急使用清单（Emergency Use Listing，EUL）中 首个扩展用于低至3岁人群的新冠疫苗，也是目前世卫紧急使用清单中唯一被推荐在3至4岁儿童中使用的新冠疫苗。 在此之前，因克尔来福 ® 的安全性、效力和生产水平均符合国际标准，在2021年6月1日被列入世卫紧急使用清单，世卫免疫战略咨询专家组（SAGE）此前已建议18岁以上成人使用该疫苗 2 。 全球超400项临床和真实世界研究表明： 克尔来福 ® 在6月龄及以上儿童及青少年 3-7 、成人 7-12 、老年人群 12-14 、孕产妇 15-16 ，以及包括患有糖尿病 17 、肾病 18 、风湿病 19-20 、透析 21-24 、肿瘤患者 25-29 在内的慢性基础疾病人群中均具有良好的安全性。 真实世界研究结果显示： 克尔来福 ® 作为加强免疫，在奥密克戎变异株暴发期间仍能为广泛人群提供安全且有效保护 3,10-12 。 香港大学研究团队针对香港特区在新冠病毒奥密克戎变异株流行背景下疫苗有效性分析的结果 30 显示，无论年轻或年长人群，接种三剂克尔来福 ® 后，在真实世界中对重症和死亡病例的保护效果均超过97%；其中，60岁以上人群完成第三剂克尔来福 ® 接种后对死亡病例的保护效果提高至98.3% （点击阅读原文） 。 2022年7月，香港大学临床医学院的一项研究 5 表明，接种两剂或三剂克尔来福 ® 对奥密克戎变异株BA.2亚型毒株所致感染具有保护效果，且接种第三剂后保护效果大幅提升。另一项香港大学李嘉诚医学院的研究 31 指出，无论采用同源或序贯免疫程序接种克尔来福 ® 或mRNA疫苗，在第三剂接种后的4-6个月内，不同免疫程序各组人员的感染发生率水平相似 （ 点击阅读原文 ） 。 克尔来福 ® 是全球使用最广泛的新冠疫苗之一。截至目前，克尔来福 ® 已在60多个国家、地区及国际组织获批使用，在14个国家和地区获批未成年人使用，全球累计供应量超29亿剂。 参考文献： 1.World Health Organization. "Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. 2022. ”https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_08November2022.pdf 2.World Health Organization. "Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process. 2021." (2021). https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_29June2021.pdf 3.Jara, Alejandro, et al. "Effectiveness of CoronaVac in children 3 to 5 years during the SARS-CoV-2 Omicron outbreak in Chile." Nature Medicine (2022): 1-1. 4.Jara, Alejandro, et al. "Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Children and Adolescents: A Large-Scale Observational Study." (2021). 5.Lau, Yu Lung, et al. "Effectiveness of BNT162b2 and CoronaVac in children and adolescents against SARS-CoV-2 infection during Omicron BA. 2 wave in Hong Kong." 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Emerging Microbes & Infections 11.1 (2022): 2304-2314. 13.Alencar, Carlos Henrique et al. “High Effectiveness of SARS-CoV-2 Vaccines in Reducing COVID-19-Related Deaths in over 75-Year-Olds, Ceará State, Brazil.” Tropical medicine and infectious disease vol. 6,3 129. 13 Jul. 2021, doi:10.3390/tropicalmed6030129 14.Arregocés-Castillo, Leonardo et al. “Effectiveness of COVID-19 vaccines in older adults in Colombia: a retrospective, population-based study of the ESPERANZA cohort.” The Lancet. Healthy longevity vol. 3,4 (2022): e242-e252. doi:10.1016/S2666-7568(22)00035-6 15.Qiao, Yaping, et al. "Safety profile of COVID-19 vaccines in pregnant and postpartum women in brazil." medRxiv (2021). 16.Paixao, Enny S., et al. "CoronaVac vaccine is effective in preventing symptomatic and severe COVID-19 in pregnant women in Brazil: a test-negative case-control study." BMC medicine 20.1 (2022): 1-8. 17.Wan, Eric Yuk Fai, et al. "mRNA (BNT162b2) and Inactivated (CoronaVac) COVID-19 Vaccination and Risk of Adverse Events and Acute Diabetic Complications in Patients with Type 2 Diabetes Mellitus: A Population-Based Study." Drug safety (2022): 1-14. 18.Cheng, Franco Wing Tak, et al. "The effectiveness and safety of mRNA (BNT162b2) and inactivated (CoronaVac) COVID-19 vaccines among individuals with chronic kidney diseases." Kidney international 102.4 (2022): 922-925. 19.Esquivel-Valerio, Jorge Antonio et al. “Adverse events of six COVID-19 vaccines in patients with autoimmune rheumatic diseases: a cross-sectional study.” Rheumatology international vol. 41,12 (2021): 2105-2108. doi:10.1007/s00296-021-05017-9 20.Haslak, Fatih et al. “Early experience of COVID-19 vaccine-related adverse events among adolescents and young adults with rheumatic diseases: A single-center study.” International journal of rheumatic diseases vol. 25,3 (2022): 353-363. doi:10.1111/1756-185X.14279 21.Medina-Pestana, José et al. “Clinical impact, reactogenicity and immunogenicity after the first CoronaVac dose in dialysis patients: a Phase IV prospective study.” Clinical kidney journal vol. 14,12 2612-2615. 17 Aug. 2021, doi:10.1093/ckj/sfab146 22.Murt, Ahmet, et al. "Antibody responses to inactivated SARS‐CoV‐2 vaccine in peritoneal dialysis patients." Seminars in Dialysis. Vol. 35. No. 3. 2022. 23.Zhao, Wen-Man, et al. "Early Humoral Responses of Hemodialysis Patients After Inactivated SARS-CoV-2 Vaccination." Journal of inflammation research (2022): 3467-3475. 24.Torres, Rubén, et al. "Clinical efficacy of SARS-CoV-2 vaccination in hemodialysis patients." Kidney international reports 7.10 (2022): 2176-2185. 25.Kang, Wei et al. “Safety of two-dose COVID-19 vaccination (BNT162b2 and CoronaVac) in adults with cancer: a territory-wide cohort study.” Journal of hematology & oncology vol. 15,1 66. 19 May. 2022, doi:10.1186/s13045-022-01265-9 26.Han, Yuling et al. “Safety and Immunogenicity of Inactivated and Recombinant Protein SARS-CoV-2 Vaccines in Patients With Thyroid Cancer.” Frontiers in immunology vol. 13 855311. 13 May. 2022, doi:10.3389/fimmu.2022.855311 27.Iriagac, Yakup et al. “Immunogenicity and safety of the CoronaVac vaccine in patients undergoing treatment for breast and lung cancer.” Bratislavske lekarske listy vol. 123,6 (2022): 401-407. doi:10.4149/BLL_2022_063 28.Yasin, Ayse Irem et al. “Efficacy and safety profile of COVID-19 vaccine in cancer patients: a prospective, multicenter cohort study.” Future oncology (London, England) vol. 18,10 (2022): 1235-1244. doi:10.2217/fon-2021-1248 29.Simsek, Melih et al. “The efficacy of BNT162b2 (Pfizer-BioNTech) and CoronaVac vaccines in patients with cancer.” Journal of medical virology vol. 94,9 (2022): 4138-4143. doi:10.1002/jmv.27835 30.HKUMed. “HKUMed proposes forward planning after Hong Kong’s fifth wave of Omicron BA.2”. https://www.med.hku.hk/en/news/press/-/media/FD4E200855C94E3D8BA10016441FE076.ashx 31.Leung, Nancy HL, et al. "Homologous and heterologous boosting with CoronaVac and BNT162b2: a randomized trial (the Cobovax study)." medRxiv (2022). 关于SINOVAC科兴 科兴控股生物技术有限公司（Sinovac Biotech Ltd.，SINOVAC 科兴）是一家总部位于中国、面向全球的生物制药企业，公司以“为人类消除疾病提供疫苗”为使命，致力于人用疫苗及相关生物制品的研究、开发、生产和供应，为全球疾病预防与控制提供疫苗产品和相关解决方案。 SINOVAC 科兴拥有多元化的疫苗产品组合，覆盖流感、病毒性肝炎、水痘、手足口病、脊髓灰质炎、狂犬病、破伤风和肺炎球菌性疾病等多个疾病领域。其中，甲型肝炎灭活疫苗孩尔来福 ® 、Sabin株脊髓灰质炎灭活疫苗（sIPV）和水痘减毒活疫苗已通过世界卫生组织预认证。 在新发突发传染病及公共卫生应急方面，SINOVAC 科兴积累了丰富的疫苗研发与产业化经验。公司曾针对SARS、H5N1、H1N1及COVID-19等重大公共卫生事件开展疫苗研发，并先后研制出全球首支SARS灭活疫苗（完成I期临床试验）、中国第一支大流行流感灭活疫苗（H5N1）盼尔来福 ® 、全球首支甲型H1N1流感疫苗盼尔来福.1 ® ，以及全球应用最广泛的新冠灭活疫苗克尔来福 ® 。 除已上市产品外，SINOVAC 科兴正持续推进创新研发管线，涵盖联合疫苗、重组蛋白疫苗，以及mRNA技术和抗体产品等新一代技术与产品平台，持续拓展在疾病预防与生物医药领域的技术布局。 秉持对创新与全球健康的长期承诺，SINOVAC 科兴持续深化与科研机构、国际组织及本地合作伙伴的合作，拓展全球业务布局。通过技术合作、本地化生产和产业协作，公司致力于提升高品质疫苗在全球不同地区的可及性，更好地满足当地疾病防控和医疗需求，并增强对未来公共卫生挑战的应对能力。

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