NEWS
AIM Vaccine led its COVID-19 mRNA Vaccine Phase Ⅲ Clinical Trial with Excellent Efficacy and Safety Results from Phase Ⅱ Study
Several domestic COVID-19 mRNA vaccine candidates had entered the clinical stage in the first half of this year. The company utilized the COVID-19 pipeline to quickly establish an mRNA vaccine development and production platform.
Recently, AIM Vaccine released Phase Ⅱ clinical trial data of its self-developed COVID-19 mRNA vaccine, LVRNA009, showing good cellular immune responses and safety.
Notably, this LVRNA009 vaccine also proved effective on Omicron variant according to independent third-party testing results.
Phase Ⅱ clinical trial data showed high responses same as previous
In detail, neutralizing antibody results against live virus tested by Wuhan Institute of Virology CAS showed that after full course immunization with AIM LVRNA009 vaccine for 14 days, GMT (geometric mean titer, measurement of antibody titer) of neutralizing antibody was 994.9 for adults in the medium-dose group and 1405.7 for adults in the high-dose group. The results demonstrate good immunogenicity of the vaccine and superior results compared with similar products.
Besides, GMT of neutralizing antibodies against virus was no less than 1000 on the 14th day after second dose. Although the GMT decreased slightly on the 28th day after second dose, it still maintained at an extremely high level.
The results also proved good efficacy of cellular immune responses. According to Dr. Bi Jinpeng, head of Vazyme central laboratory, IL-2, IL-4, IL-13, and IFN-γ of experiment groups all showed a significant increase on the 7th day after vaccination, indicating good cellular immune responses.
At the same time, the safety results of LVRNA009 were also satisfactory. Vaccine-related adverse reactions were mainly Grade Ⅰ events with no serious adverse event (SAE) or adverse event requiring special attention, indicating low safety risk of the vaccine.
Earlier this year, AIM Vaccine released Phase I clinical data for this vaccine which showed good safety and efficacy and the results were “better than expectation”. In the Phase I clinical trial, LVRNA009’s GMT of live virus neutralizing assay was higher than its counterpart’s, which showed excellent immunogenicity.
In eight months’ time, AMI Vaccine’s Phase II clinical data remained at a high level, which also promises a high feasibility of mRNA vaccine technology route.
Dr. Peng Yucai, Principal Scientist of AIM Vaccine and General Manager of Liverna, said that this result testified AIM-Liverna mRNA technology platform and also proved that domestic mRNA vaccine technology route could be established and even be superior in technology.
AMI COVID-19 mRNA vaccine clinical trial is in the first tier
In the first half of this year, various domestic COVID-19 mRNA vaccine candidates entered clinical trial stage. Currently, among COVID-19 mRNA vaccine trials, AMI Vaccine maintains its leadership in the pace and outcomes of the trial.
It is reported that ARCov vaccine developed by Abogen/Walvax has entered Phase III stage and SYS6006 by CSPC has entered Phase II stage. CanSinoBIO stated in a recent research note that its COVID-19 mRNA vaccine also entered Phase II stage. In addition, COVID-19 mRNA vaccine candidate developed by Recbio and Rhegen Bio has also entered clinical stage.
In fact, compared with other traditional COVID-19 vaccines, the advantages of mRNA vaccines include simple production process, no need for cell culture or animal-based medium, fast synthesis speed, low cost and high efficiency. Therefore, they are favored by many leading pharmaceutical companies who are actively developing related technologies.
Based on the scope of current market, CITIC Securities estimated that the market size of COVID-19 mRNA vaccine could to be around $46b in 2022.
Guosen Securities assumed that emerging domestic mRNA companies might be able to compete with overseas leaders after the establishment of R&D platform and realization of large-scale production during the short-term priority of COVID-19 vaccine.
Considering the current conditions of continuous mutation of SARS-CoV-2 and recurrent regional outbreaks, vaccination is still the most effective preventive measure. Wu Jinglei, Director of Shanghai Municipal Health Commission, also said in a media broadcast earlier that booster vaccination could further improve preventive efficacy.
Distinguished Professor Xu Jianqing from Institutes of Biomedical Sciences Fudan University commented that mRNA vaccines have significant advantages in antibody retain duration and immune responses to viral mutants. He believed that due to its fast speed in development, reliable safety, high immunogenicity, and ability to simultaneously activate antibodies and T cells, mRNA vaccine technology has a bright future.
According to a report from Sinolink Securities, various types of COVID-19 vaccines using different technological approaches such as mRNA vaccines, recombinant protein vaccines, recombinant adenovirus vector vaccines, and inactivated virus vaccines have been approved for marketing globally. Among them, the immune effect of mRNA vaccine has shown excellent performance with significant improvement in protection against mutant strains after three booster shots.
AIM Vaccine stated the group has been taking great efforts to develop COVID-19 Omicron variant targeted mRNA vaccines in response to the challenge of COVID-19 prevention and control caused by new variants.
