邵龙飞、王迪、王静怡
By Shao Longfei, Wang Di and Wang Jingyi
北京，7月29日 -- 7月26日，由陈薇院士团队领衔研制的雾化吸入用重组新冠疫苗（腺病毒载体）临床研究数据在著名国际学术期刊《柳叶刀•传染病》发表，这也是全球首个公开发表的新冠疫苗黏膜免疫临床试验结果。
BEIJING, July 30 -- The clinical research data of the recombinant COVID-19 vaccine (Adenovirus Type 5 Vector) in inhalation form developed by Chinese military medical scientist Chen Wei and her team has been published on the famous international academic journal The Lancet Infectious Diseases on July 26. It is also the world's first publication of the clinical trial results on mucosal immunity of COVID-19 vaccines.
研究结果显示，该疫苗安全性好，无肌肉注射的不良反应。接种时，人员只需通过雾化吸入，就可以获得黏膜免疫、细胞免疫和体液免疫的三重保护。获得同等细胞免疫反应水平所需剂量仅为肌肉注射用剂量的1/5。此外，如果在肌肉注射后采用雾化吸入加强免疫，可产生高水平中和抗体。
The results showed that the vaccine is safe and has no adverse reactions caused by intramuscular injection. During vaccination, the recipient only needs to inhale to obtain triple protection of mucosal immunity, cellular immunity and humoral immunity. The dosage required to obtain the same level of cellular immune response is only 1/5 of that for intramuscular injection. In addition, high levels of neutralizing antibodies can be produced if nebulized inhalation is used to boost immunity after intramuscular injection.
该疫苗与陈薇院士团队领衔研发的同类型肌肉注射疫苗相比，在制剂处方、包装形式和生产设施等方面完全一致，仅在接种方式和接种剂量上有所不同。此外，将疫苗放入雾化器的过程，操作简单方便。
Compared with the same type of intramuscular vaccine developed by Chen Wei's team, the vaccine is completely consistent in terms of formulation prescription, packaging form and production facilities, and only differs in vaccination method and dosage. In addition, the process of putting the vaccine into the nebulizer is much more simple and convenient.
军事科学院军事医学研究院研究员研究员侯利华表示，一方面，该款疫苗不需要注射，不会出现胳膊疼痛、肿胀等不良反应，有助于提高民众接种意愿。另一方面，雾化吸入疫苗的剂量很低，相当于大幅度提高了疫苗的产量。对于已经注射疫苗的人群，雾化吸入能够发挥显著的多重免疫效果，抵御新冠病毒的变异，因此适合大规模人群推广使用。
Hou Lihua, a researcher at the Institute of Military Medicine under the Academy of Military Sciences, said that on the one hand, the vaccine does not require injection, and there will be no adverse reactions such as arm pain and swelling, which will help increase people's willingness to get vaccinated. On the other hand, the dosage of nebulized inhalation vaccine is very low, which is equivalent to a substantial increase in vaccine production capacity. Besides, nebulized inhalation can exert significant multiple immune effects and resist COVID-19 variants for people who have been vaccinated and thus it is suitable for large-scale promotion.
这项临床试验于2020年9月在武汉启动，由军事科学院军事医学研究院与武汉大学中南医院共同主持研究。目前正在有序推进二期临床试验。接下来，科研人员将继续进行与时间赛跑，积极申请该疫苗的紧急使用。
This clinical trial was launched in Wuhan in September 2020 and was co-hosted by the Institute of Military Medicine under the Academy of Military Sciences and Zhongnan Hospital of Wuhan University. The Phase II clinical trial is currently underway in an orderly manner. Next, the researchers will continue to race against time and actively apply for emergency use of the vaccine.
此前，由陈薇领衔团队研发的重组新冠疫苗（腺病毒载体）已于2月25日获国家药品监督管理局附条件批准上市，是我国首个获批的国产腺病毒载体新冠病毒疫苗，单针接种且可以在2-8℃条件下运输保存。目前，该型疫苗已获得墨西哥、巴基斯坦、匈牙利、智利、阿根廷等多国紧急使用许可。
Previously, the recombinant COVID-19 vaccine (Adenovirus Vector) developed by the team led by Chen Wei was conditionally approved by China’s National Medical Products Administration (NMPA) on February 25, as the first domestically-made adenovirus vector COVID-19 vaccine. It is a single-dose vaccine and can be transported and stored at 2-8°C. At present, the vaccine has obtained emergency use authorizations in Mexico, Pakistan, Hungary, Chile, Argentina and other countries.
