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Lyophilized mRNA-lipid nanoparticles vaccine with long-term stability and high antigenicity against SARS-CoV-2

Liangxia Ai; Yafei Li; Li Zhou; Hao Zhang; Wenrong Yao; Jinyu Han; Junmiao Wu; Ruiyue Wang; Weijie Wang; Pan Xu; Zhouwang Li; Chengliang Wei; Haobo Chen; Jianqun Liang; Ming Guo; Zhixiang Huang; Xin Wang; Zhen Zhang; Wenjie Xiang; Bin Lv; Peiqi Peng; Shangfeng Zhang; Xuhao Ji; Zhangyi Li; Huiyi Luo; Jianping Chen; Ke Lan; Yong Hu.
Preprint en Inglés | PREPRINT-BIORXIV | ID: ppbiorxiv-479867
Advanced mRNA vaccines play vital roles against SARS-CoV-2. However, due to their poor stability, most current mRNA delivery platforms need to be stored at -20{degrees}C or -70{degrees}C, which severely limits their distribution. Herein, we present lyophilized SARS-CoV-2 mRNA-lipid nanoparticle vaccines, which can be stored at room temperature with long-term thermostability. In the in vivo Delta virus challenge experiment, lyophilized Delta variant mRNA vaccine successfully protected mice from infection and cleared the virus. Lyophilized omicron mRNA vaccine enabled to elicit both potent humoral and cellular immunity. In booster immunization experiments in mice and old monkeys, lyophilized omicron mRNA vaccine could effectively increase the titers of neutralizing antibodies against wild-type coronavirus and omicron variants. In humans, lyophilized omicron mRNA vaccine as a booster shot could also engender excellent immunity and had less severe adverse events. This lyophilization platform overcomes the instability of mRNA vaccines without affecting their bioactivity, and significantly improved their accessibility, particularly in remote regions.