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The Omicron variant is highly contagious and spreads rapidly. Older adults are a high-risk group due to increased risk of severe illness resulting from advanced age, underlying health conditions, or lack of vaccination. Experts say that in addition to personal protection, timely vaccination against COVID-19 is particularly important for older adults. Lizhu V-01 offers good protection for high-risk groups: In a sequential booster Phase III clinical trial, group studies of high-risk individuals showed that V-01 provided 71.83% protection for those with underlying conditions.

Globally, increasing attention is being paid to high-risk groups such as older adults with underlying conditions.

Most older adults have underlying health conditions, increasing their risk of severe illness after contracting COVID-19. COVID-19 vaccination reduces the risk of infection and illness, significantly lowering the risk of severe illness and death after infection. Older adults without contraindications and who meet the vaccination criteria are advised to get vaccinated as soon as possible. Considering that the level of neutralizing antibodies produced after COVID-19 vaccination in older adults is lower than in younger people, and the decline in neutralizing antibody levels is more significant in older adults, it is recommended that older adults not only complete the full course of COVID-19 vaccination but also receive booster shots as soon as possible at 6-month intervals.

Globally, hundreds of millions of doses of Chinese COVID-19 vaccines have been administered to older adults, with the oldest recipients being 106 years old both internationally and domestically. On March 23, the Brazilian Ministry of Health announced that it recommends a fourth dose of the vaccine for people over 80 years old four months after receiving their third dose. Whether other age groups will receive a fourth dose will be adjusted as needed in the future.

Lizhu Group (000513.SZ) previously announced that its holding subsidiary, Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd. (“Lizhu Monoclonal Antibody”), in collaboration with the Institute of Biophysics, Chinese Academy of Sciences, has completed the interim primary data analysis of the sequential booster Phase III clinical trial for its “recombinant novel coronavirus fusion protein vaccine” (“V-01”) and obtained key data. Lizhu Group stated that the sequential booster recombinant coronavirus fusion protein vaccine provides good protection against Omicron.

Improving protection for high-risk groups is a key focus of epidemic prevention and control, and recombinant protein vaccines may be the key as booster shots. The Lizhu V-01 vaccination regimen involves two injections. Data from its Phase II clinical trial was published in the Chinese Medical Journal in July 2021. The results showed that the vaccine has excellent immunogenicity and safety, particularly in the elderly group, where the overall incidence of vaccine-related adverse events was lower than in the corresponding adult group. This indicates that V-01 has the potential to become a vaccine for all age groups.

Impressive Data: Lizhu V-01 shows up to 71.83% protection for high-risk groups.

Recently, Fudan University published an important study in BMC Medicine, evaluating the long-term neutralizing antibody kinetics and predicting their protection and immunity levels based on neutralizing antibody data from several vaccines. According to the actual efficacy data from the sequential booster study (28-84 days), using the Lizhu vaccine as a booster after two doses of inactivated vaccine effectively combats Omicron infection.

Data shows that Lizhu V-01 offers good protection for high-risk groups: In a sequential booster Phase III clinical trial, group studies of high-risk individuals showed that V-01 provided 71.83% protection for those with underlying conditions.

Sequential booster immunization is an immunization strategy that uses vaccines of different technological routes with a certain time interval and number of doses to further improve the preventive effect while considering safety. For example, with COVID-19 vaccination: 2 doses of "inactivated vaccine" for basic immunization + a 3rd dose of "recombinant protein vaccine" for booster immunization is called sequential booster immunization, also known as heterologous booster immunization.

V-01, a novel, independently developed recombinant protein COVID-19 vaccine, was initiated in July 2020 by Lizhu Monoclonal Antibody in collaboration with the Institute of Biophysics, Chinese Academy of Sciences. Lizhu Group stated that the Phase III clinical trial protocol for V-01 sequential booster is the world's first randomized, double-blind Phase III clinical trial to study sequential booster protection. Compared with the Phase III clinical data of vaccines already on the market domestically and internationally, it achieved an absolute protection rate of 61.35%, which is a very good result and meets WHO standards.

The announcement shows that this sequential booster regimen is designed for sequential boosting based on two doses of inactivated vaccine, using a superior efficacy standard relative to protection, unlike the traditional blank placebo regimen. V-01 conducted Phase III clinical trials of sequential boosting in Pakistan and Malaysia, planning to inject V-01 booster or placebo in a 1:1 ratio among 10,722 healthy adults aged 18 and above who completed 2 doses of inactivated vaccine 3-6 months prior.

As of the date of this key data analysis, 10,241 participants were actually enrolled, and a total of 110 primary endpoint cases were monitored after vaccination (the protocol requires analysis when at least 103 primary endpoint cases are reached). According to the results of the trial analysis at this stage, the absolute protective efficacy of V-01 after sequential boosting is 61.35%, demonstrating significant superior efficacy.

Lizhu V-01 as a booster shot shows good sequential booster immunization effects: Results from multiple domestic and international sequential immunization clinical studies of V-01 show that after vaccination as a booster shot, V-01 can rapidly and significantly increase neutralizing antibody titers, effectively combating multiple variants, showing strong neutralizing activity against the Omicron variant, comparable to the wild-type neutralizing activity; high-titer neutralizing antibodies are maintained for a long time, and the booster immunization effect in the elderly population is no less than that in the adult group.

Preliminary analysis of clustered outbreaks in multiple regions of China this year shows that vaccinated older adults have a significantly lower risk of severe illness than unvaccinated older adults. However, cumulative data on COVID-19 vaccination in China shows that as of February 25, about 220 million people aged 60 and above have received vaccination coverage, and about 211 million have completed the full course of vaccination. The vaccination rate remains low for those aged 60 and above, especially those aged 80 and above. Increasing the vaccination rate among older adults is of great significance in reducing COVID-19 mortality.

Lizhu Group stated that it is actively promoting the conditional marketing application of the vaccine and thanked the relevant departments for their full support of the company's early work on V-01. Undoubtedly, the early launch of Lizhu V-01 in China will provide more flexible and scientific options for future continuous booster immunizations, contributing to the fight against the epidemic, especially for older adults and high-risk groups with underlying conditions. We look forward to the early launch of Lizhu V-01.

Source: Securities Market Red Weekly