In January 11th, the official WeChat official account of Chongqing Zhifei Biological Products Co.Ltd(300122) (300122) was disclosed. The Indonesia Drug Administration (BPOM) held a press conference. The New Coronavirus vaccine (CHO cell) (Zifivax) was approved as a sequential (heterologous) booster for COVID-19 inactivated vaccine.
It is reported that penny K Lukito pointed out that as the basic immunization, zifivax vaccine was inoculated with two sequential (heterologous) booster injections of covid-19 inactivated vaccine. Inoculating one dose of zifivax vaccine six months after the inactivated vaccine can increase the neutralizing antibody level by about 30 times.
was urgently used in Indonesia last year
Back in January 29, 2020, Chongqing Zhifei Biological Products Co.Ltd(300122) ‘s wholly owned subsidiary, Chi Fei Long Ma and the Institute of Microbiology of China Academy of Sciences, formally signed the framework agreement on cooperation. The two sides jointly developed the “recombinant subunit vaccine of genetic engineering”, that is, the recombinant New Coronavirus vaccine (CHO cell).
It is reported that the above projects have been included in the key special project of “public security risk prevention and control and emergency technical equipment” of the national emergency special research and development plan. They are prepared by expressing and purifying pathogen antigen proteins in engineering cells through genetic engineering, and have completely independent intellectual property rights. This vaccine adopts recombinant DNA technology, takes the receptor binding region (RBD) of covid-19 virus spike glycoprotein (s protein) as the antigen, and is supplemented by traditional adjuvants. It does not carry any form of exogenous labels. It has unique conformation, high immunogenicity and good safety.
Since December 12, 2020, the above vaccines have successively carried out international multicenter phase III clinical trials in Hunan Province, Uzbekistan, Indonesia, Pakistan and Ecuador. It is planned to enroll a total of 29000 ordinary people over the age of 18, and vaccinate three doses of vaccines according to the immunization procedures in 0, 1 and 2 months.
According to the results of international multicenter phase III clinical trial, the protective efficacy of recombinant covid-19 vaccine (CHO cells) against covid-19 of any severity was 81.43%, meeting the effectiveness standard of covid-19 vaccine required by who. The preliminary genotyping analysis showed that the protective efficacy of the vaccine against alpha mutant was 92.68%, and the protective efficacy against delta mutant was 81.38%.
The results of the above safety data show that there is no significant difference in the overall incidence of adverse events / reactions between the vaccine group and the placebo group, and the safety is good. Chongqing Zhifei Biological Products Co.Ltd(300122) indicates that the key data results of the completed phase III clinical trial show that the recombinant covid-19 vaccine (CHO cells) has good safety and disease prevention effect in the population meeting the clinical trial protocol.
After one year’s R & D and clinical trials, the recombinant covid-19 vaccine (CHO cells) was registered and listed in Uzbekistan on March 1, 2021, becoming the first recombinant subunit covid-19 vaccine registered and listed in the world; On March 10 of the same year, it was approved for emergency use in China; On October 7, it was approved for emergency use in Indonesia.
ideal candidate for heterologous enhancer
Since the end of 2021, Omicron virus has continued to spread all over the world, and the epidemic prevention situation is still grim.
On December 20 last year, researchers such as the Institute of Microbiology of the Chinese Academy of Sciences and academician Gao Fu of the Chinese Center for Disease Control and prevention jointly published an academic paper on the preprint platform biorxiv, pointing out that Omicron did have serious immune escape in the serum of rehabilitated patients, but the neutralization activity was better preserved in those vaccinated with three doses of inactivated vaccine or protein subunit vaccine.
Among them, the neutralization of Omicron virus strain in the recombinant protein subunit vaccine (zf2001) group remained 100% positive, and the neutralizing antibody (NAB) titer was only reduced by 3.1 times. Compared with other vaccines on the market, the data in zf2001 (0,1,5) group were better.
The article also mentioned that in zf2001 group, the injection time of the second and third needles was prolonged (4 ~ 6 months), 100% positive was maintained in the neutralization of Omicron virus strain, and the titer of neutralizing antibody (NAB) was only reduced by 3.1 times.
62.5% of the people vaccinated with three doses of inactivated vaccine, 56.25% of the people vaccinated with zf2001 (scheme 0, 1 and 2) and 100% of the people vaccinated with zf2001 (scheme 0, 1 and 5) were positive for and antibodies to Omicron. As for neutralizing antibody titer, there was a 17.4-fold decrease from prototype to Omicron in the serum group of rehabilitated patients. The inactivated vaccine group decreased by 5.1 times and zf2001 (0,1,2) group decreased by 10.6 times; The NAB titer of Omicron in zf2001 (0,1,5) group was only reduced by 3 times.
Based on the above findings, researchers are prompted to consider that multiple strengthening and prolonging the time interval of vaccination may be beneficial to deal with severe variants, such as Omicron. This is consistent with mRNA vaccine studies, which show that people vaccinated with three doses are more able to maintain the neutralization of Omicron variants.
Earlier on December 3, 2021, Xie Xiaoliang and Cao Yunlong of Peking University, Jin ronghua of Capital Medical University and Yu Hongjie of Fudan University jointly published relevant research papers in the famous international academic journal Cell Research.
It is reported that the purpose of this paper is to evaluate the effect of heterologous third dose zf2001 or homologous third dose corona VAC (Kexing vaccine) on vaccine induced VOC antibody. The results show that the third dose of corona VAC or zf2001 vaccine can rapidly induce humoral immunogenicity, while zf2001 induces a higher humoral immune response, which is an ideal candidate for heterologous enhancers.
(source: Securities Times · e company)
