截至2022年3月底，由科兴控股生物技术有限公司（下称“SINOVAC科兴”）研制的克尔来福®已在61个国家/地区/国际组织获批，在56个国家和地区使用，并在全球范围内针对适种人群展开了诸多临床及真实世界研究。同时，克尔来福®在特殊健康状况人群中也积累了大量的应用经验，显示出良好的安全性、免疫原性及有效性。
免疫功能低下1
https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac167/6543937?login=true
艾滋病病毒（HIV）感染2
https://www.sciencedirect.com/science/article/pii/S2352301822000339
自身免疫性风湿性疾病3
https://link.springer.com/article/10.1007/s00296-021-05017-9
全身性红斑狼疮4
https://onlinelibrary.wiley.com/doi/full/10.1002/acr.24824
多发性硬化症5
https://doi.org/10.1016/j.msard.2022.103690
干燥综合症6
https://link.springer.com/article/10.1007/s10067-022-06134-x
甲状腺功能减退症7
https://www.liebertpub.com/doi/abs/10.1089/thy.2021.0684
糖尿病、肥胖症8
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3822780
非透析肾病9
https://doi.org/10.1101/2022.01.14.22269182
肾移植受者10
https://journals.lww.com/transplantjournal/Fulltext/2022/01000/Clinical_Impact,_Reactogenicity,_and.40.aspx
腹膜透析人群11
https://academic.oup.com/ckj/article/14/12/2612/6353597?login=false
癌症患者12
https://www.futuremedicine.com/doi/full/10.2217/fon-2021-1248
孕妇13
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-022-02353-w
产妇14
https://www.medrxiv.org/content/10.1101/2021.12.14.21267777v1
既往新冠病毒感染者（在研，暂无数据）
2021年3月至10月，巴西近2万名孕妇接种两剂克尔来福®后，对新冠病毒有症状感染的保护效果为41%（95% CI 27.1 - 52.2），对重症的保护效果为85%（95% CI 59.4–94.8），在接种至少一剂克尔来福®的孕妇中无人死亡[13]。
2021年4月至8月，巴西孕、产妇人群共接种170万剂不同类型新冠疫苗，据安全性观察研究结果显示：克尔来福®总体不良事件发生率较巴西同期使用的另3款新冠疫苗更低，不良事件以1级为主，无严重不良事件发生，安全性良好14。
克尔来福®安全性良好
优于巴西同期使用的另3款新冠疫苗
2021年3月至7月，土耳其一项针对776名恶性实体瘤患者（试验组）和715名无恶性实体瘤人群（对照组）的前瞻性、多中心队列研究结果显示：克尔来福Ⓡ在恶性实体瘤患者患者中应用安全、有效12。
试验组血清阳性率为85.2%，对照组血清阳性率为97.5%，恶性实体瘤患者的高血清阳性率表明这些患者接种克尔来福®可有效预防新冠感染。对照组接种第1剂后不良反应发生率显著高于患者，患者组接种第1剂后不良反应发生率为15.9%，对照组的发生率为22.5%，对照组最常见的不良反应是局部疼痛(9.7%)，患者组最常见的不良反应是疲劳(6.4%)。由此可见，克尔来福Ⓡ在该人群中安全性良好，不良反应发生率低，且大多为轻度不良反应。
恶性实体瘤患者接种克尔来福Ⓡ后
不良反应发生率略低于健康人群
2021年2月至3月，巴西一项针对215名HIV感染者（试验组）和296名健康人群（对照组）的前瞻性队列研究结果显示：HIV感染者接种克尔来福Ⓡ后的安全性和免疫原性良好2。
HIV感染者接种克尔来福Ⓡ后
不良事件发生率与健康人群相当
墨西哥一项针对225名自身免疫性风湿病患者横断面研究显示，患者接种疫苗后可产生免疫应答，在六种疫苗中，克尔来福Ⓡ不良事件发生率最低，安全性更好3 。
世界卫生组织建议，中度和重度免疫功能低下或缺陷人群（如恶性肿瘤患者、器官移植患者、正在使用免疫抑制剂治疗患者、艾滋病病毒感染者等人群）感染新冠病毒后重症风险较高，且接种疫苗后的有效性和免疫原性较低。因此，上述人群应尽快接种加强剂次/补充剂次来增强免疫应答并提供额外的保护15。
参考文献
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