QS-21：全球关键疫苗背后的“增效秘诀”

近年来，数款对全球健康具有重大意义的疫苗已获批或接近获批，其中针对带状疱疹、RSV、疟疾和结核病的疫苗尤为重要。这些疾病的疫苗研发曾屡屡受挫，许多早期候选疫苗或因临床试验失败，或因资源匮乏而停滞1。在 RTS,S/AS01 获批之前，世上尚无疟疾疫苗；而唯一的结核病疫苗——卡介苗（BCG）已使用了超过一个世纪。新型疫苗佐剂的出现，为攻克这些科学难题提供了关键助力。

里程碑式的疟疾疫苗
欧洲药品管理局（EMA）于2015年对 RTS,S/AS01（Mosquirix） 的积极科学意见，标志着史上首款疟疾疫苗的诞生2。2021年，世界卫生组织（WHO）推荐将其用于儿童疟疾预防3。数据显示，该疫苗可显著降低幼儿的临床疟疾和重症疟疾发生率4。然而，由于供应有限，许多疟疾流行国仍未能获得足量分配3。据估计，其稳定年需求将高达1.1亿剂5。

2023年，第二款疟疾疫苗 R21/Matrix-M 获批，为全球抗疟行动增添了重要工具6,7。在高传播地区季节性接种时，这两款疫苗均可预防约75%的疟疾发作8。在加纳、肯尼亚和马拉维的试点项目中，RTS,S/AS01 显示出降低儿童重症住院和死亡率的积极效果9。模型预测，R21/Matrix-M 疫苗能有效降低儿童疟疾死亡率10。

结核病疫苗的新希望
M72/AS01E 是目前最具希望的结核病候选疫苗，正处于III期临床试验阶段。早期试验显示，它对感染结核分枝杆菌的青少年和成人，在三年内提供了约50%的肺结核病保护力3。若未来能获得批准并广泛接种，模型估计到2050年，它在印度和南非可能避免数千万结核病例和数百万死亡11,12。

应对呼吸道威胁
2023年，首款呼吸道合胞病毒（RSV）疫苗 Arexvy (RSVPreF3/AS01E) 获批，用于保护老年人。在关键临床试验中，其对60岁及以上成人预防重症RSV相关下呼吸道疾病的效力高达94%13。当然，其全球健康影响力的充分发挥，还取决于中低收入国家的流行病学状况、卫生系统实施接种的能力与意愿，以及相较于其他疫苗的效用14,15。

已惠及百万人的带状疱疹疫苗
在本报告所关注的疫苗中，用于预防老年人带状疱疹的 Shingrix 已创造了巨大的公共卫生价值与市场份额。WHO推荐老年人及高风险人群接种16。但值得注意的是，该疫苗在中低收入国家的可及性仍然有限17，其全球潜力的全面发挥，同样面临流行病学数据、卫生系统能力和疫苗比较效用等多重挑战。

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参考文献
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