机构地区:[1]中国医学科学院医学信息研究所,北京100020 [2]中国医学科学院北京协和医院,北京100730 [3]广东省深圳市卫生健康发展研究和数据管理中心,广东深圳518000
出 处:《中国药业》2022年第14期24-29,共6页China Pharmaceuticals
基 金:国家自然科学基金[L1924064];北京协和医学院教育基金会项目[2021DLX005];中国医学科学院医学与健康科技创新工程[2021-I2M-1-056]。
摘 要:目的分析目前全球病毒载体疫苗产品研发态势。方法计算机检索Cortellis数据库中全球病毒载体疫苗产品,从产品数量、研发阶段、适应证分布、原研机构分布等角度分析全球病毒载体疫苗研发态势,比较各国研发进展。结果全球共有330个病毒载体疫苗在研或上市,其中13个已获批注册或上市,5个处于Ⅲ期临床试验阶段。适应证以感染类疾病为主,其中新型冠状病毒肺炎(COVID-19)、流行性感冒和埃博拉出血热等适应证已有相应产品上市,肿瘤类适应证(如前列腺肿瘤、乳腺肿瘤)和其他类适应证(如过敏、宫颈发育不良)尚无产品进入Ⅲ期临床试验阶段;英国牛津大学研发的产品最多(28个),美国Greffex公司、NantCell公司和AlphaVax公司及丹麦Bavarian Nordic公司研发的产品均超过10个;已上市产品的原研机构主要来自美国、中国、俄罗斯、英国、丹麦和加拿大,荷兰、意大利和土耳其也有产品进入Ⅲ期临床试验;我国机构研发进展相对较快,中国人民解放军军事医学科学院与康希诺生物联合,于2017年研发成功1个埃博拉疫苗,并于2021年成功上市1个COVID-19疫苗。结论全球已有多个用于感染类疾病适应证的病毒载体疫苗产品获批注册或上市,但用于肿瘤和其他类适应证的产品距离上市较远。美国、中国、俄罗斯、英国、丹麦、加拿大等国的研发机构在该领域研发进展较快。Objective To analyze the worldwide status of research and development(R&D)of viral vector-based vaccines.Methods The worldwide status of R&D of viral vector-based vaccines was analyzed in terms of product quantity,R&D stage indication distribution and original research institution distribution based on information of viral vector-based vaccines retrieved from the Cortellis database,and the R&D progress of viral vector-based vaccines in various countries was compared.Results In the worldwide,330 viral vector-based vaccines were under development or have been launched,of which thirteen vaccines have been registered or launched,and five vaccines were in phaseⅢclinical trials.The indications of the vaccines were mainly infectious diseases,among which the vaccines for coronavirus disease 2019(COVID-19),influenza and Ebola hemorrhagic fever(EBHF)had been launched,but there were no vaccines for tumors(such as prostate tumor and breast tumor)and other indications(such as allergy and cervical dysplasia)investigated in phaseⅢclinical trial stage.Oxford University in the United Kingdom(UK)has originally developed the most vaccines(28 vaccines).Greffex,NantCell and AlphaVax in the United States of America(USA)and BavarianNordic in Denmark have all investigated more than 10 vaccines respectively.The original research institutions of the launched products were mainly from the USA,China,Russia,the UK,Denmark and Canada.Institutions from the Netherlands,Italy and Turkey also had vaccines investigated in phaseⅢclinical trials.The R&D institutions in China have made relatively rapid progress.The Academy of Military Medical Sciences of the PLA and CanSino Bio have successfully launched an Ebola vaccine in 2017,followed by a COVID-19 vaccine in 2021.Conclusion Some viral vector-based vaccines for infectious diseases have been registered or launched in the worldwide,but the vaccines for tumors and other diseases are far from being launched.R&D institutions in the USA,China,Russia,the UK,Denmark,Canada and other countries have m
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