People's Daily health client reporter Wang Zhenya
On May 1, the inactivated vaccine of the New Coronavirus variant of the Aumecreon variant developed by Sinopharm's Beijing Institute of Biological Products of Sinopharm Group launched a clinical trial in Shulan (Hangzhou) Hospital. Clinical volunteers were vaccinated with the Omilon inactivated COVID-19 vaccine. This is the world's first inactivated covid-19 vaccine to enter clinical trials against the Omiljung variant.
Why develop a vaccine with the Omiljung variant? What are the technical advantages of inactivated vaccines? Is it too late to enter the clinic now? ...... In response to a series of issues of public concern, the People's Daily health client reporter interviewed Zhang Yuntao, chief scientist and vice president of Sinopharm Group China Biologics, to interpret them one by one.
Volunteers in the clinical trial of the New Coronavirus Vaccine of Theo strain of China Bio-Olays were vaccinated. Courtesy of Shulan (Hangzhou) Hospital
Why develop the Aomi Kerong vaccine?
Zhang Yuntao, Chief Scientist and Vice President of China Biology. Photo courtesy of Sinopharm China Biologics
Aomi Kerong is not a "large flu", which has the characteristics of fast transmission speed, high infection rate and strong concealment, and has caused local epidemics in Shanghai, Beijing, Jilin and other places in the mainland. The R0 value of the original strain of the new coronavirus is estimated to be around 2.5, the R0 value of the Delta strain is between 5 and 6, and the transmission ability of the Aumechjong is 3 to 4 times that of the Delta strain. Each person infected with the Aomi Kerong BA.2 strain can infect 12 people.
Zhang Yuntao, chief scientist and vice president of China Biology, told the People's Daily health client reporter that compared with the previous mutated strains, the area of mutation of the Aomi Kerong strain is larger, and it has been largely "looked" different from the original strain.
In the face of the Aumechjong variant, the effectiveness of the new crown vaccine and antibody treatment drugs previously developed by various technical routes has declined to varying degrees. Zhang Yuntao further introduced that when the new crown vaccine that has been listed faces the beta and Delta variant strains, the protection rate has dropped by 20%-30%, and in the face of the Aomi Kerong mutant strain, the original vaccine protection power initially developed has dropped by about 60%-80%. It can be said that in order to better prevent and control the epidemic, under the new situation, it is very necessary to develop the Aomi Kerong vaccine.
What is the progress of vaccine development of the Olmikron variant?
Sinopharm China Biologics has been paying attention to the prevalence of mutant strains and carrying out relevant research work at the same time. The First Time the Opichron Variant Strain was introduced from the University of Hong Kong, and the research and development of the Inactivated Vaccine for the Semikeron Variant was quickly launched on December 9, 2021.
"Data obtained from previous animal experiments show that the inactivated vaccine of the Semikron variant produces high-titer neutralizing antibodies against the Semikron variant and a variety of VOC variants." Zhang Yuntao introduced that in addition to the broad spectrum of antigens in inactivated vaccines, Sinopharm China Biologics also has sufficient production capacity preparations, and the advantages of early technology platform research and development are obvious.
However, in actual research and development, inactivation, recombinant and mRNA are carried out simultaneously. Zhang Yuntao introduced, "At the same time, we also launched the research and development of the Recombinant COVID-19 Vaccine and mRNA Vaccine of the Semikron variant. At present, Sinopharm China Biologics Beijing Institute of Biological Products, Wuhan Institute of Biological Products, china Institute of Biological Research, a total of three Omiljung variants of the new crown vaccine have been approved by the Ministry of Health of Abu Dhabi, UNITED Arab Emirates for clinical trials.
The world's first inactivated vaccine against the Olmikeron variant of the new crown virus entered clinical trials has completed its first dose in Hangzhou on May 1.
Zhang Yuntao said that scientific research has been going all out to promote, from the preclinical research data that has been obtained, it will have a better effect on preventing the incidence and infection caused by the Omikerong strain, and has a good cross-neutrality and protection of the mutant strains that have been found, which has a positive effect on the prevention and control of the epidemic at home and even in the world.
Is it possible to cope with subsequent viral mutations?
Recently, new strains of Omikeron, BA.4 and BA.5, have emerged in 20 countries around the world, making the new variant more transmissible than existing variants and likely to evade vaccines and the natural immunity of infected people. The Olmicoreon strain is constantly mutating, and the world's drug development and vaccine development do face common problems.
Zhang Yuntao believes that in order to be able to respond more specifically to the impact of Omicron, the development of a more protective and more specific new crown vaccine is the only way for us to finally defeat the epidemic, which is the experience gained from the fight against infectious diseases and a necessary part of the process of human scientific exploration.
The clinical study of the Omiljung new crown vaccine adopted the form of randomized, double-blind, and cohort studies to design clinical studies of two cohorts. The safety and immunogenicity of the Inactivated COVID-19 vaccine for the Semickon variant strain were evaluated in people aged 18 years and older who had completed 2 or 3 doses of COVID-19 vaccination, and in a blank population that had not been vaccinated against COVID-19.
Since the outbreak of the Aomi Kerong variant and the outbreak of the epidemic, Sinopharm China Biologics immediately organized a scientific research team to start the research and development of a vaccine for the Aomi Kerong strain. At present, for the O strain vaccine, we have completed the adaptive passage of the O strain and the establishment of the poison seed bank, and on the basis of the existing inactivated vaccine in the previous stage, we have completed the establishment of production process, the research and development of quality control methods, the determination of quality standards, and the stability study.
Zhang Yuntao introduced that the results of animal experiments show that the Inactivated Vaccine of Omi kerong has a good cross-neutralization and protection of the VOC variants that have been found. High titer neutralizing antibodies can be produced against the Almi kerong strain and its variants that have been discovered, and according to the data collected so far, the vaccine is effective for BA.1 and BA.2 and XE.