Based on the existing covid-19 vaccine, how to improve the resistance to Omicron variant? Sequential booster immunization (also known as “heterologous booster immunization”) is regarded as one of the important exploration directions.
Recently, the recombinant New Coronavirus fusion protein vaccine (“V-01”), developed by Joincare Pharmaceutical Group Industry Co.Ltd(600380) (600380.SH) indirect holding company, Li Zhu mAb, has completed the interim master data analysis of the three phase clinical trials strengthened by the trial, and has obtained key data.
On the afternoon of February 18, Zhu Baoguo, chairman of Joincare Pharmaceutical Group Industry Co.Ltd(600380) Pharmaceutical Group, told the first financial reporter that as of February 18, the company had begun to submit the listing application of v-01 as covid-19 vaccine sequential booster to the Chinese evaluation department, and the listing application to other countries was also in progress.
It is worth noting that the v-01 sequential enhanced phase III clinical trial scheme is the world’s first randomized, double-blind phase III clinical trial for sequential enhanced protection of Omicron research.
V-01 has been approved and developed since July 2020. It is an innovative covid-19 recombinant protein vaccine developed by lizumab in cooperation with the Institute of Biophysics, Chinese Academy of Sciences. V-01 molecule is composed of interferon, pan epitope, RBD dimer and Fc fusion protein.
The sequential strengthening plan is a sequential strengthening design based on two doses of inactivated vaccine. The phase III clinical trial of sequential strengthening is carried out in Pakistan and Malaysia. It is planned to inject v-01 strengthening needle or blank placebo 1:1 among 10722 healthy adults aged 18 and over who have completed two doses of inactivated vaccine for 3 ~ 6 months.
As of the date of this critical data analysis, 10241 people were actually enrolled, and a total of 110 cases of primary endpoint cases after vaccination were monitored (the scheme requires at least 103 cases of primary endpoint cases to be analyzed). According to the analysis of the present stage, the results showed that the annual incidence rate of V-01 sequential enhancement and two needle inactivated vaccine was 6.73% and 12.80%, respectively, with significant difference between the V-01 sequential and two needle inactivated vaccine groups (P=0.0012). The absolute protective force of v-01 after sequential strengthening is 61.35%, which has significant strong and excellent effect. The genotyping and first-generation sequencing of covid-19 virus in 60 of all valid samples submitted for examination in this test are Omicron (the rest are still undergoing second-generation sequencing), indicating that the sequential strengthening of v-01 can produce good protection against covid-19 caused by Omicron infection. At the same time, no safety problems worthy of attention were found.
“This clinical trial adopts the standard of strong relative protection and excellent effect, which is different from the control of traditional blank placebo protocol. 61.35% of the absolute protection data obtained this time is based on the protection effect of inactivated vaccine and the data generated under the Omicron epidemic, which also meets the WHO standard.” Joincare Pharmaceutical Group Industry Co.Ltd(600380) Jin Fang, chief scientist of Pharmaceutical Group, told the first financial reporter.
Jin Fang also said that the v-01 vaccine adopts conventional adjuvant, which has good safety, and the adverse reaction rate is far lower than that of all non inactivated vaccines. At present, more than 90 domestic raw materials can be developed and replaced in the vaccine supply chain. At present, more than 90 domestic raw materials can also be developed and fully stored. In addition, at present, the annual production capacity of stock solution stored in Lizhu vaccine commercialization workshop can reach 3.5 billion doses; The production capacity of the three preparation lines can reach 120 million doses / month and 1.5 billion doses / year. In case of emergency, entrusted production can be considered to further expand the production capacity.
