On January 8, AIM Vaccine held a meeting at Shulan (Hangzhou) Hospital to report on the analysis results of the phase I clinical trial data of its mRNA COVID-19 vaccine (LVRNA009). Safety data on the phase I clinical trial was released by Director Chen Guiling of Phase I Clinical Trial Laboratory of Shulan (Hangzhou) Hospital, and the results indicated high safety and well toleration. Also, Dr. Shan Chao from Wuhan Institute of Virology, CAS announced the virus neutralizing antibody test at the meeting, “the GMT on day 56 of the adult low-dose group, the adult medium-dose group and the adult high-dose group was 576.6, 1591.2 and 845.7 respectively.” Compared to the phase I clinical trial results of similar products, it demonstrated excellent safety and immunogenicity. At present, the phase I clinical trials of all 3 China’s mRNA vaccines are carried out at the Phase I Clinical Trial Laboratory of Shulan (Hangzhou) Hospital, among which the first mRNA vaccine is already under phase III clinical trial overseas.
At the meeting, top-notch experts acclaimed the phase I results of the mRNA COVID-19 vaccine (LVRNA009) of AIM Vaccine. Based on the current situation of pandemic prevention and control, experts expressed that drugs will not bring an end to the pandemic; vaccine remains the most effective means of prevention and control, and will continue to be applied on a large scale; thus, the sequential immunization with COVID-19 vaccine in China is of great significance. Renowned public health expert and epidemiologist Zeng Guang believed that novel coronavirus may be continuously weakening but cannot be eliminated, and it may coexist with the mankind over the long term; therefore, China must implement sequential immunization to establish a solid and most effective barrier of colony immunity. Zeng Guang expressed the importance of vaccination in plain language: “With vaccine, there is nothing to be afraid of!” Professor Wang Yu – distinguished visiting professor from Vanke School of Public Health, Tsinghua University and former director of Chinese Center for Disease Control and Prevention – elaborated on his opinion with the examples of H7N9 and poliomyelitis. According to him, antivirus drug is not the ultimate solution to the spread and infection of virus, and COVID-19 vaccine will continue to be used on a large scale. Professor Wang explained how mRNA technology can be applied in vaccines, and pointed out that our understanding of the biological behaviors of novel coronavirus is far from enough due to the suddenness of its outbreak, which requires the efforts of R&D enterprises and scientists and endless researches on new vaccine technologies. Distinguished professor of Fudan University and researcher of Institutes of Biomedical Sciences Xu Jianqing set forth the challenges in COVID-19 prevention and control and the latest progress of vaccines. At present, the proportion of asymptomatic infection remains high, and it is an extremely challenging task to achieve colony immunity through infection or a single vaccine. Xu said mRNA vaccine has obvious advantages as a booster short in view of its antibody durability and response to variants.
Prof. Peng Yucai, lead scientist of AIM vaccine, expounded on the features of its mRNA COVID-19 vaccine at the meeting, with a comprehensive introduction made to its advantages in terms of gene sequence design, mRNA delivery method, vaccine stability and product quality control. Prof. Peng said, the mRNA COVID-19 vaccine (LVRNA009) originated from the R&D base of LIVERNA, which has begun its R&D of mRNA vaccine since 2017 as the first in China. In addition to a strong team and its mRNA R&D technology, LIVERNA also has its own pilot-scale production workshop for producing phase I and phase I clinical samples, which guarantees the quality control of its mRNA products. He commented, “This is rare.” In addition, the internationally most advanced and most widely applied LNP delivery technology is adopted for this mRNA COVID-19 vaccine, its advantages including higher mRNA encapsulation and delivery efficiency than all previous technologies, good and controllable particle homogeneity, relatively simple production process, and easily realizable scale-up. “Now, our confidence in its R&D is boosted by factors on every aspect.”
Prof. Qin Xiaofeng of Systems Research Center of Institute of Basic Medical Sciences (Chinese Academy of Medical Sciences & Peking Union Medical College) and Suzhou Institute of Systems Medicine felt heartened by the phase I clinical trial data of AIM mRNA vaccine. He expressed: “With few adverse reactions and high neutralizing antibody titer, this product has great prospects.”
Besides clinical research, the industrialization of mRNA COVID-19 vaccine is another hot topic at the meeting. Dr. Xiong Changyun, who is charge of mRNA industrialization at AIM Vaccine, introduced the future path of industrialization of its mRNA vaccines. With modular workshops for mRNA vaccine production under planning in Ningbo, Shanghai and/or Beijing, AIM Vaccine has confidence in satisfying the market demands with its production capacity.