China has launched the world's largest sequential clinical trial of the new crown vaccine

On May 9, sinopharm Group China Biological Beijing Institute of Biological Products (hereinafter referred to as "Aodu") inactivated new coronavirus vaccine sequential clinical trial was launched in Hunan Province. This is the first time that a sequential clinical study of the OVAR vaccine has been carried out in a population that has been vaccinated against THE NEW CROWN after the launch of the chinese bio-ovum vaccine in Hangzhou, Zhejiang Province on May 1.

According to the Global Times reporter, this is the world's first comprehensive design of the Olympic strain new crown virus inactivated vaccine sequential clinical trial, but also the largest number of enrolled people so far, the earliest launch of the Olympic strain new crown inactivated vaccine sequential clinical trial research. The study will evaluate the safety and immunogenicity of vaccines in humans. The relevant clinical plan needs to be further discussed with experts and drug regulatory departments to determine, and it is expected to take about 3-4 months to complete.

Zhang Yuntao, chief scientist and vice president of China Biologics, said in an interview with the Global Times reporter that the clinical research plan enrolled more than 4,000 people, which is currently the world's largest clinical study of the new crown vaccine against the Austrian strain. The trial was designed with randomized, double-blind, controlled studies to evaluate the safety and immunogenicity of the Omiljun strain COVID-19 inactivated vaccine for COVID-19 in people aged 18 years and older who had received 2 or 3 doses of the COVID-19 vaccine at different intervals and in different orders.

According to Zhang Yuntao, the previous clinical research on the new crown vaccine was divided into three phases, and large-scale protective clinical studies would be used in the third phase. This time, the clinical study has made some modest adjustments according to the guidelines of the State Food and Drug Administration for the mutant strain of the new crown vaccine, combined with the overall status of the current vaccinated COVID-19 vaccine in China and the world, and the sequential study in the blank population and the vaccinated population to systematically evaluate the safety and efficacy of the new variant vaccine, which is different from the design of the protective clinical study of the original vaccine.

"The relevant plan of this clinical research work needs to be further discussed with experts and drug regulatory departments to determine, and it is expected to take about 3-4 months to complete." Zhang Yuntao said.

Not long ago, Sinopharm's China Bio-Olympic Vaccine was approved for clinical trials by the State Food and Drug Administration, and the clinical trial approvals from the Hong Kong Pharmaceutical Industry and the Poisons Board. On May 1, Aoxin Vaccine launched a clinical study on blank populations in Hangzhou, Zhejiang Province.

Zhang Yuntao said that the Austrian vaccine systematically evaluated the immunogenicity of animals before being approved for clinical studies, and used serum obtained from immune animals to conduct in vitro cross-neutralization experiments on various variants of high concern to WHO. Judging from the results, the Olympian vaccine has a good neutralization activity against the Aomi Kerong variant strain, and the neutralization activity of beta, Delta and prototype strains has also been improved, and the effect is also very ideal.

Does the success of the development of the Austrian vaccine mean that the current COVID-19 vaccine is ineffective? In this regard, Zhang Yuntao explained that the New Crown Vaccine of Aoluo adopts the same inactivated vaccine technology route as the original new crown vaccine. The New Crown Vaccine is not a complete negation of the previous NEW CROWN vaccine, and the previous generation of NEW CROWN vaccines is still effective.

"In the outbreak of the epidemic in Hong Kong some time ago, it can also be seen that inactivated vaccines have obvious protective effects on severe illness and death, especially people over 60 years old. So, the original vaccine is still effective," Zhang said.

However, Zhang Yuntao pointed out that the clinical trial of the Austrian vaccine was not designed as the fourth dose of the new crown vaccine.

"The immunization procedure for the inactivated COVID-19 vaccine in mainland China is two full doses of immunization + a third dose of enhanced immunization. The clinical trial observed the safety and immunogenicity of the Olympian vaccine in people who had received two and three doses of inactivated COVID-19 vaccine and those who had not received COVID-19 vaccine. After obtaining the clinical research data, the best follow-up vaccination regimen will be evaluated," Zhang Yuntao told the Global Times.

As Omilon gradually became the main epidemic strain and the number of infected people continued to rise, the claim that Omilon was "not fatal", "zero severe disease", and "large flu" was also very popular.

Zhang Yuntao stressed that 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 transmission capacity of the Olmiqueron is 3 to 4 times that of the Delta strain, and each person infected with the Aomiqueron BA.2 strain can infect 12 people. Compared with the previous mutated strains, the region of mutation of the Aomikron strain is larger, and it has been largely "looked" different from the original strain.

Therefore, in the face of the Omicron variant, the effectiveness of the new crown vaccine and antibody treatment drugs previously developed by various technical routes has declined to varying degrees. In order to better prevent and control the epidemic, in the new situation, it is very necessary to develop the Aumequeron vaccine.

On April 12, two inactivated vaccines of the new coronavirus developed by China Bio-Beijing Institute of Biological Products and Wuhan Institute of Biological Products were approved by the University of Hong Kong and the Ethics Committee of the Hong Kong Island West Hospital Network research, and on April 13, they were approved by the Clinical Trial Approval of the Hong Kong Pharmacy and Poisons Authority, and were officially approved to carry out sequential immune clinical research on the new crown vaccine in Hong Kong. On April 26, the inactivated vaccine of the new coronavirus of China Biological Beijing Institute of Biological Products was approved by the State Food and Drug Administration for clinical trials.

On April 29, two inactivated vaccines of the new coronavirus of China Biologics Beijing and wuhan institute of biological products, and the recombinant protein new crown vaccine developed by the Sinopharm Institute of Biotechnology of China Medicine/National Engineering Research Center for New Vaccines, a total of three new coronavirus vaccines were approved by the Ministry of Health of Abu Dhabi in the United Arab Emirates. This is an important progress in the international multi-center clinical trial of the New Crown Vaccine of China Bio-Olympic Strain.

On May 1, the clinical study of the Ao zhu new crown vaccine in the blank population of the Beijing Institute of Biological Products of China Biologics was officially launched in Hangzhou, Zhejiang Province. The Chinese Bio-Olays COVID-19 vaccine has thus become the world's first inactivated Ovaran covid-19 vaccine to enter clinical trials.

"From the current clinical scope involved, the contraindications to the Olympian vaccine are consistent with the first generation of inactivated vaccines, and there are no other special matters. However, after the first generation of vaccines are widely used, China Biology has carried out corresponding clinical studies in diabetes, hypertension, AIDS, autoimmune deficient diseases and organ injuries, and the contraindications should gradually decrease in the future. Zhang Yuntao added.