Global pandemic control is still facing enormous challenges after more than two years since the outbreak of the COVID-19. Following the Delta and Beta variants, Omicron variant emerged at the end of 2021, and its enhanced infectivity has cast a shadow over the global COVID-19 control. Recently, Omicron quickly spread in Japan and South Korea, and the number of newly confirmed cases in South Korea has exceeded 90,000 for two consecutive days. Although COVID-19 vaccine booster shots have been administered across the globe since 3Q2021, vaccine efficacy is shown to vary among vaccine products, and it is crucial to find and apply a vaccine with stronger protection against Omicron.
Livzon Pharmaceutical Group Inc. ("Livzon"), a long-established pharmaceutical company dedicated to research and development of innovative product, has developed a recombinant protein COVID-19 vaccine (the "V-01 vaccine") leveraging their recombinant protein technology platform since 2021.
It is reported that the V-01 vaccine is a COVID-19 recombinant protein vaccine jointly developed by Livzon MabPharm Inc. ("Livzon MAB") and the Institute of Biophysics, Chinese Academy of Sciences (the "Institute"). To date, Livzon MAB has conducted two global Phase III clinical trials in multiple countries, including (1) two doses of V-01 as basic immunization scheme, and (2) V-01 as a sequential booster for people who have received two doses of inactivated vaccine 3 to 6 months earlier. This is the only global Phase III clinical trial of sequential boosting immunization of the COVID-19 vaccine that have been approved by the regulatory authorities of multiple countries.
On February 16, Livzon has completed the interim analysis of the Phase III clinical trial for the sequential booster protocol, and released key data from this trial. According to the results disclosed, the person-year incidence rates of the V-01 sequential booster (after two doses of inactivated vaccine) group vs. the group who have only received two doses of inactivated vaccine were 6.73% and 12.80%, respectively, which showed a significant statistical difference (P=0.0012); and the absolute vaccine efficacy of the V-01 sequential booster was 61.35%, which is also shown to be significantly superior. The absolute vaccine efficacy after V-01 sequential booster has met World Health Organization's (WHO) standards.
Sixty valid genotype sequencing samples in this trial were confirmed to be Omicron using first-generation genotype sequencing of SARS-CoV-2 virus (the rest of samples are in the process of second-generation sequencing), indicating that V-01 sequential booster can produce good protection against Omicron infection. This is the first COVID-19 vaccine in the world of which the Phase III trial interim results have been disclosed since the Omicron outbreak.
Additionally, the Phase II trial results showed that V-01 had excellent immunogenicity and safety; and the overall incidence of adverse events was lower in the elder group than that of the younger adult group in comparison.
According to the company, the manufacturing of V-01 is well established in China with stable raw material supply and adequate reserves, ready to provide for global market once launched. The production line of Livzon MAB has been approved by the Guangdong Food and Drug Administration, and the vaccine production license has been granted. It is also disclosed that a workshop with an annual bulk product capacity of 3.5 billion doses is up and running at Livzon MAB, and the annual production capacity of formulated product has reached 1.5 billion doses.
With 71.32 million confirmed infected cases and 5.85 million cumulative deaths worldwide, the development and application of a safe and effective COVID-19 vaccine is urgent as the virus is spreading and mutating rapidly. Livzon, as a member of the Chinese Vaccine Research and Development Team, is in the process of obtaining EUA (Emergency Use Authorization) and conditional marketing approval for V-01 vaccine domestically and abroad, so as to provide a more robust and clinical-proven option for continuous immunization boosting for general public and to contribute to the global pandemic control efforts.