The world’s first! The first clinical shot of the Omicron variant inactivated vaccine!

IntroductionLanguage

China’s Omicron vaccine research and development has taken an important step!

Recently, the clinical study of the new coronavirus inactivated vaccine of Omicron variant developed by Sinopharm China Bio-Beijing Institute of Biological Products was officially launched in Hangzhou, and the first dose of vaccination was completed. This is the world’s first inactivated COVID-19 vaccine that has entered clinical trials against Omicron mutants.

In this regard, Li Lanjuan, an academician of the Chinese Academy of Engineering, said that the current Omicron virus is still a serious threat to the health of people, and the research and development of related vaccines is of great significance.

No.1

Made in China, the world’s first needle

Blank population may be directly vaccinated against Austrian strains

Recently, there have been outbreaks of new coronary pneumonia in many places in China. It has the characteristics of strong infectivity, short incubation period, short passage time, and difficult prevention and control.

On April 26, the State Drug Administration officially approved Sinopharm Biotech and Sinopharm China Bio-based Omicron (Omicron) (hereinafter referred to as Omicron). The new coronavirus inactivated vaccine developed by the SARS-CoV-2 strain) has entered clinical research to evaluate the safety and immunogenicity of the new coronavirus variant vaccine in various populations. (Previously reported one-click direct access)

After obtaining the clinical approval, the National Drug Clinical Trial Institute of Shulan (Hangzhou) Hospital immediately carried out the preparatory work before the start of the project, in the shortest time After completing the review of the ethics committee of the drug clinical trial and obtaining the ethics approval, the clinical study was officially launched on May 1.

The clinical study of the Austrian strain of COVID-19 vaccine will adopt the form of a randomized, double-blind, cohort study, and has been A sequential immunization clinical study was conducted in people aged 18 and over who had completed 2 or 3 doses of the new crown vaccine to evaluate the safety and immunogenicity of the inactivated vaccine against the new coronavirus of the Omicron variant. After the clinical research data is approved, blank populations who have not been vaccinated against the new crown vaccine can be directly vaccinated with the Austrian strain vaccine.

Zhang Yuntao, Chief Scientist and Vice President of China Biotechnology, previously stated that before the approval of the clinical study of the Austrian strain vaccine, the animal immunogenicity evaluation was systematically carried out. The sera obtained from the immunized animals were subjected to in vitro cross-neutralization experiments on various variants of high concern to WHO.

Judging from the results, the Austrian strain vaccine has a good neutralizing activity against the Omicron variant strain, and is resistant to beta, delta and prototype strains. The neutralization activity of the strain was also improved, and the effect was still very satisfactory.

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Experts comment on Austrian strain vaccine

The next step will continue to verify and observe the effect of the vaccine

Li Lanjuan, academician of the Chinese Academy of Engineering, said that the development of the vaccine of the mutant strain of Omicron is very important< /span> Of course, the original vaccine is still effective, but after the development of the vaccine against the mutant strain, it may (have) better immune effect. This also proves China’s speed and China’s efficiency in fighting the epidemic (work). We believe that through rigorous clinical research, the safety and effectiveness of (vaccine) will be further proved to ensure the application of future vaccines.

At the same time, she introduced that the vaccine development for the Omicron variant was started on December 9, 2021, and was obtained on April 26, 2022. Clinical trial approval from the State Food and Drug Administration. This clinical study will contribute the strength of clinical trial personnel to the prevention and control of the novel coronavirus pneumonia epidemic.

Previously, for the vaccine research and development of Omicron variants, Zheng Zhongwei, head of the vaccine research and development team of the scientific research team and director of the Science and Technology Development Center of the National Health Commission of China, once said that from Omic As soon as the Rong variant first appeared, the Chinese vaccine research and development team has already taken action. “The basic principle we follow is ‘it is better to have it than to use it, never to use it and not have it’.”

Based on existing research data, Academician Li Lanjuan said, should be said that people who have not been vaccinated can of course be vaccinated, and the next step is to conduct clinical trials for people who have been vaccinated to (verify) whether it will be more effective. Because he has already been vaccinated, he may already have antibodies, so it should be applied to people who have not been vaccinated or infected with the new crown to prove that after the (newly developed) vaccine is vaccinated , the level of immunogenicity and comprehensive antibodies he produced to prove the effectiveness of the (new vaccine). At the same time, we will further observe the clinical response of the (new vaccine) to prove the safety of the (new vaccine).

Source / Beijing Daily, The Paper, China Daily

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