Late last night, the WHO announced that the new crown vaccine developed by Kexing Zhongwei was included in the emergency use list.
Source: WHO screenshot
This is the second domestically produced new crown vaccine after the new crown vaccine BBIBP-CorV developed by the Beijing Institute of Biological Products of Sinopharm Group was included in the Emergency Use List (EUL) by WHO, and it is also the seventh in the world to be listed by WHO COVID-19 vaccines on the emergency use list.
The other five are the Pfizer vaccine, two Oxford vaccines ( Korean version and Indian version), Johnson & Johnson vaccine and Moderna vaccine.
EUL mainly evaluates the quality, safety and efficacy of the new crown vaccine, risk management plan and plan applicability (such as cold chain requirements), in the case of Sinovac's new crown vaccine, the WHO's evaluation also includes on-site inspections of production facilities . As an inactivated vaccine , Kexing's new crown vaccine storage requirements are simple, easy to manage, and suitable for resource-poor environments.
The following is the WHO's recommendation for Kexing's new crown vaccine vaccination based on existing evidence:
- It is recommended that adults 18 years of age and older receive Kexing's new crown vaccine with two doses 2 to 4 weeks apart.
- The overall effectiveness of the vaccine is 51%, and the effective rate for preventing severe illness is 100%.
- Due to the limited number of elderly people who participated in the clinical trial, it is impossible to accurately assess the effect of the elderly vaccination against Sinovac.
- Nevertheless, WHO does not recommend an upper age limit for Sinovac vaccinations.Because preliminary data and immunogenicity data from multiple countries show that Sinovac vaccine may be protective in the elderly, and there is no theory that the safety of the vaccine in the elderly population and the young population is different.
Research and development background
Since the outbreak of the new crown pneumonia caused by the new crown virus at the end of 2019, the main research and development technical routes of major research and development institutions around the world for the new coronavirus vaccine are divided into: inactivated vaccine, subunit vaccine , nucleic acid vaccine (DNA, RNA) and viral vector vaccines (replicating, non-replicating).
As one of the most traditional types of vaccines, inactivated vaccines culture the virus in vitro and then inactivate it with heat or chemical reagents (such as β-propiolactone) to create a strong immune response to . vaccine.
Inactivated vaccine preparation process (Source: Science)
Among them, two inactivated vaccines produced by Sinopharm Beijing Institute and Kexing Zhongwei have been at the forefront of the global wave of new crown vaccine research and development. The former was released on May 7. It was placed on the emergency use list by WHO.
On May 7, 2020, Science officially published an inactivated vaccine developed by Sinovac as the first unit, which is also the world's first publicly published novel coronavirus vaccine article.
Since then, the Phase 1/2 clinical trial data of Sinovac vaccines have been published. The results showed that the vaccine was well tolerated, the adverse reaction of was relatively mild, and a large amount of neutralizing antibody could be produced after two injections, and the vaccination strategy and dosage of the vaccine were also clarified.
As for its Phase 3 clinical trials, in South America, , , Brazil, , Chile, , Southeast Asia, , Indonesia, and Turkey in the Middle East are four countries in different regions and with their own characteristics. Multi-center clinical research layout.
Next, let's take an inventory of the Phase 3 data of Sinovac vaccine to see the effectiveness and safety of the most concerned.
More than three phases of data, extensive detailed
- Brazil: effective rate 50.6%
On April 12 this year, the protection data of Sinovac's Phase 3 clinical trial in Brazil was also published in the "Lancet" preprint database SSRN.
The data is exhaustive, showing that between July 21 and December 16, 2020, 12,396 participants were recruited and received at least one dose of the vaccine or placebo.
There were 253 confirmed cases of COVID-19 in the trial (85 of 4953 participants in the vaccine group and 168 of 4870 participants in the placebo group).
The data results show that the protective efficacy of the vaccine against hospitalized, severe and dead new crown cases is 100.00% (95% CI: 56.37-100.00), and the protective efficacy for new crown cases with obvious symptoms and requiring medical treatment is 83.70% (95 %CI: 57.99-93.67), the protective efficacy for all new crown cases including mild symptoms that do not require medical attention is 50.65% (95%CI: 35.66-62.15).
Brazil Phase III Clinical Trial Protective efficacy against COVID-19 after 14 days of 2 doses of immunization (PPS)
WHO-level 3 and above: new crown cases requiring medical attention; WHO-level 4 and above: hospitalization, severe illness and death Cases (5 severe cases, 1 death case); VE: protective efficacy (source: Sinovac)
- Turkey: 91.25% effective rate
The target population of the Phase III clinical trial conducted by Sinovac in Turkey is divided into: healthcare workers at high risk persons (K-1) and the general population at normal risk (K-2), follow the 0,14 day vaccination schedule.
As of December 23, 2020, a total of 7371 subjects have been enrolled, including 918 subjects in the K-1 cohort subjects, and 6453 subjects in the K-2 cohort. The analysis showed that the protective efficacy of 2 doses of the vaccine against COVID-19 after 14 days was 91.25% (95%CI: 71.25-97.34).
Turkey Phase III Clinical Trial Protecting against COVID-19 14 days after 2 doses of immunization (Source: Sinovac)
- Indonesia: 94% effective
According to the results of a real-world study published by the Indonesian Ministry of Health, the study period was January 2021 From 13th to March 18th, when the epidemic broke out in Indonesia, it was mainly medical staff in Jakarta (priority vaccination group). The average age of was about 30 years old, and 60% were women.
The results of the follow-up study show that Sinovac vaccines provide strong protection for vaccinators, and full vaccination can reduce the risk of symptomatic infection by 94% and reduce the risk of death by 98%.
- Among the 28,055 unvaccinated people, 17 died, mortality 0.06%;
- Of the 8,458 vaccinated with one shot, 3 died, with a mortality rate of 0.03%;
- Inoculated with two shots Of the 91,777 people, 1 died, a mortality rate of 0.001%.
The study also underscores the importance of full vaccination, with only one shot providing limited protection.
Overall, this real-world study in Indonesia demonstrates the good protection of Sinovac vaccines, significantly reducing the risk of symptoms and death. However, due to the limited sample size (infections and deaths) seen so far, more complete data is needed to make a more accurate assessment.
The number of deaths from COVID-19 infection without vaccination and after vaccination (source: sehatnegeriku)
Protection effect of mutant strain
In addition to extensive and detailed population protection data, Sinovac also disclosed vaccine immunization against mutant strains data on the cross-neutralization effect.
In the previous phase 3 clinical trial in Brazil, 32 (71.1%) of 45 vaccinees tested had neutralizing activity against B.1.1.28 wild-type , and 31 (68.9%) against the Brazilian mutant P.1 (B.1.1.28.1) had neutralizing activity, and 36 (80.0%) had neutralizing activity against P.2 (B.1.1.28.2).
Another study was based on the serum of 80 subjects aged 26 to 45 years before and after immunization with a 0,14-day program, against 12 new coronavirus strains (CZ02, WZL, WGF, ZJY, SSH, JWL) circulating at home and abroad. , ZYF, HAC, HJL, ZXZ, QHF and NOOR) for serum cross-neutralization detection, and cell culture micro-neutralization test for serum neutralizing antibody detection.The results of
show that the antibodies induced by after immunization with this vaccine have the ability to cross-neutralize different new coronavirus strains (including D614G mutant strains). between. What is the significance of
being approved this time?
The inclusion of Sinoviz’s new crown vaccine on the WHO emergency use list is a prerequisite for the supply of vaccines through the COVID-19 Global Access Mechanism (COVAX), and allows countries to speed up the regulatory approval of the import and vaccination of COVID-19 vaccines.
So far, Sinovill's new crown vaccine has been approved for emergency use or marketed with conditions in more than 30 countries, including China, Brazil, Indonesia, Chile, and Singapore.
CONMEBOL President Alejandro Domínguez also officially announced on April 13 that Sinovac became the official healthcare partner of the 2021 Copa America. Sinovac donated 50,000 doses of the new crown vaccine to the South American Football Federation to support the 2021 America's Cup. The popular football superstar Messi will also be vaccinated with the new crown vaccine, and will then fly to South America to participate in the 6 ~July America's Cup football game held in Argentina and Colombia .
The 50,000 COVID-19 vaccines donated by Sinovac to the South American Football Federation arrived at the airport (Source: Sinovac)
Finally, in the face of the epidemic, the destiny of mankind is the same. As long as the epidemic in one country is not well controlled, it will be difficult for the world to have a peaceful day. Sino-Vintage's new crown vaccine has entered the WHO's emergency use list, which is a contribution to all mankind.
The current epidemic situation continues to repeat, and new mutant strains appear frequently. Getting an effective and safe vaccine as soon as possible will be an important weapon to defeat the epidemic. (planning: gyouza)
Acknowledgments: This article has been professionally reviewed by Microbiology of the Chinese Academy of Sciences, a well-known scientific blogger @second-hand scientist
Thanks Hokkaido University Master of Neuroscience, a senior medical consultant Zhuang of Shengnuo Shilihe's contribution to this article
Source of the title: Figure Worm Creative
References:
.C. Liu et al., Research and Development on Therapeutic Agents and Vaccines for COVID-19 and Related Human Coronavirus Diseases. ACS Central Science 6, 315-331 (2020).
.Q. Gao et al., Development of an inactivated vaccine candidate for SARS-CoV-2. Science 369, 77-81 (2020).
.Y. Zhang et al., Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis 21, 181-192 (2021).
.R. Palacios et al., Double-Blind, Randomized, Placebo-Controlled Ph ase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials 21, 853 (2020) .
5. http://www.sinovac.com.cn/product/product.php?class2=5
Article source: Lilac Garden
