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
2022-11-23

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。


 图片关键词

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." (2022).

6.Florentino, Pilar T V et al. “Vaccine effectiveness of CoronaVac against COVID-19 among children in Brazil during the Omicron period.” Nature communications vol. 13,1 4756. 13 Aug. 2022, doi:10.1038/s41467-022-32524-5.

7.Yang, Bingyi, et al. "Effectiveness of CoronaVac and BNT162b2 Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA. 2 Infections in Hong Kong." The Journal of Infectious Diseases 226.8 (2022): 1382-1384.

8.Wu, Dan et al. “Effectiveness of Inactivated COVID-19 Vaccines Against Symptomatic, Pneumonia, and Severe Disease Caused by the Delta Variant: Real World Study and Evidence - China, 2021.” China CDC weekly vol. 4,4 (2022): 57-65. doi:10.46234/ccdcw2022.009

9.McMenamin, Martina E et al. “Vaccine effectiveness of one, two, and three doses of BNT162b2 and CoronaVac against COVID-19 in Hong Kong: a population-based observational study.” The Lancet. Infectious diseases vol. 22,10 (2022): 1435-1443. doi:10.1016/S1473-3099(22)00345-0

10.Suah, Jing Lian et al. “Real-world effectiveness of homologous and heterologous BNT162b2, CoronaVac, and AZD1222 booster vaccination against Delta and Omicron SARS-CoV-2 infection.” Emerging microbes & infections vol. 11,1 (2022): 1343-1345. doi:10.1080/22221751.2022.2072773

11.Yang, Bingyi et al. “Effectiveness of CoronaVac and BNT162b2 Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.2 Infections in Hong Kong.” The Journal of infectious diseases vol. 226,8 (2022): 1382-1384. doi:10.1093/infdis/jiac360

12.Yan, Vincent Ka Chun, et al. "Effectiveness of BNT162b2 and CoronaVac vaccinations against mortality and severe complications after SARS-CoV-2 Omicron BA. 2 infection: a case–control study." 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).





© SINOVAC科兴