SINOPHARM COVID-19 Vaccine: 79.34% Effective and ask for approval

SINOPHARM COVID-19 Vaccine: 79.34% Effective and ask for approval . Interim analysis data of the first phase III clinical trial of the first COVID-19 inactivated vaccine: the protective effect reaches 79.34%, and the marketing application has been submitted.

According to reports, according to the statistical analysis of SINOPHARM China Biotech, the results of the interim analysis of the COVID-19 virus inactivated vaccine phase III clinical trial showed that the safety of the COVID-19 virus inactivated vaccine of Sinopharm China Biotech Beijing company after vaccination is good.

After two injections of the immunization program, All vaccinators in the vaccine group produced high-titer antibodies, and the neutralizing antibody positive conversion rate was 99.52%. The protective efficacy of the vaccine against the disease caused by the new coronavirus infection (COVID-19) was 79.34%.

The data result reached the relevant technology of the World Health Organization. Standards and relevant standards in the “Guiding Principles for Clinical Evaluation of Vaccines for Prevention of Novel Coronavirus (Trial)” issued by the State Food and Drug Administration. Currently, Sinopharm China Bio-Beijing Company has formally submitted a conditional listing application to the State Food and Drug Administration of China.

The COVID-19 pneumonia epidemic that has swept the world has made vaccine research and development the focus of the world’s attention.

A few days ago, a number of COVID-19 vaccines around the world announced the interim data of Phase III clinical trials.

• On November 16, Moderna announced that the effectiveness of its mRNA-1273 COVID-19 vaccine candidate was 94.5%;
• Pfizer also announced that the effective rate of its COVID-19 vaccine cooperating with BioNTech was 95%;
• November 23, the University of Oxford announced that the effective degree of the COVID-19 vaccine it cooperated with AstraZeneca was 70.4% on average;
• December 30, China Biosciences announced that the protective efficacy of the inactivated COVID-19 vaccine approved in China was 79.34%.

The effective vaccines announced above far exceed the 50% approved baseline.

The clinical data of many COVID-19 vaccines is dazzling. Many people simply focus on the effectiveness and believe that the most effective vaccine is the best. Therefore, it is concluded that China’s COVID-19 vaccine is slightly inferior. Today we will talk about how to objectively evaluate a vaccine.

To measure a vaccine depends on its performance in many aspects. Safety, effectiveness, accessibility, and adaptability are all worthy of attention. After all, a vaccine must be safe and effective, and it must be used by the public. It’s OK and affordable. Safety is the foundation, and effectiveness is a very important indicator on the premise that vaccine safety is acceptable. In addition, it must meet the requirements of sufficient output, convenient transportation and storage, and affordable final prices.

In other words, in the face of the COVID-19 pneumonia epidemic, the development of a vaccine is like taking an exam. When judging the test takers’ scores, it is by no means just looking at a course of Chinese or mathematics, but with language, math, foreign language, mathematics, science, and chemistry A good score can be called balanced development and comprehensive ability.

In terms of safety, the technical route adopted by the COVID-19 vaccine with published data is as follows:

• Pfizer-technology route of mRNA nucleic acid vaccine
• Moderna-technical route of mRNA nucleic acid vaccine
• AstraZeneca-Adenovirus vector vaccine technology route
• Sinopharm Sino Bio-Technology Route of Inactivated Vaccine

Inactivated vaccines have mature technical routes and high safety. They have been validated for several decades. In the world’s immunization programs, inactivated vaccines account for a large proportion and are widely used in the prevention of various diseases and long-term research. Verified by clinical use, inactivated vaccines are very safe and effective.

Up to now, most of the successfully marketed products worldwide are inactivated vaccine products, including polio vaccine (a new class of drug), hand, foot and mouth disease vaccine (a new class of drug), forest encephalitis vaccine (a new class of drug), and hemorrhagic fever Vaccines, etc.

Protective aspects:

The calculation of protection effectiveness is based on scientific and rigorous research programs and calculation formulas. At present, the positive conversion rate of “neutralizing antibodies” that can eliminate the virus in the body after all approved vaccination is above 90%, which means that almost everyone can theoretically produce antibodies against the virus after vaccination.

In terms of accessibility:

• It is mainly considered from two perspectives, one is the convenience of storage and transportation, and the other is the guarantee of production capacity.
• When safety and effectiveness are guaranteed, the Moderna vaccine needs to be stored and transported at minus 20°C, which can be stable for 6 months.
• Pfizer’s vaccine is more demanding. It can be stored and transported at minus 70°C and can be stable for 6 months, and can only be stable for 5 days at 2-8°C.
• The storage conditions for the inactivated vaccines of Sinopharm Group China Biologics are stored and transported in the dark at 2-8°C and stable for 24 months.

Therefore, China’s COVID-19 vaccine has obvious advantages in storage and transportation. The cold chain storage and transportation conditions (2-8°C) meet the global cold chain system standards and meet the national conditions of most countries. This greatly reduces storage and transportation requirements and improves vaccine availability. 

About capacity:

The CEO of Pfizer’s partner BioNTech SE said that he is looking for various efforts to enable next year’s COVID-19 vaccine production to exceed the previously promised 1.3 billion doses.

AstraZeneca’s partner in China, Kangtai Biological, promised to ensure that the annual production capacity of at least 100 million doses of the COVID-19 vaccine AZD1222 will be reached by the end of 2020, and will be expanded to at least 200 million doses by the end of 2021 The needs of the Chinese market.

Moderna expects to be able to produce 20 million doses of the COVID-19 vaccine this year and 500 million to 1 billion doses next year.

The high-level biosafety production workshops of the COVID-19 inactivated vaccines established by Sinopharm Group Sino Biotech in Beijing and Wuhan are expected to have a production capacity of more than 1 billion doses next year, which is equivalent to the international production capacity.

Adaptability:

Mainly reflected in the wide application to different countries, different groups of people, and different age groups in the world. The current public data shows that Sinopharm China Bio-COVID-19 Vaccine Phase III clinical enrollment of 60,000 people, volunteers covering 125 nationalities, the number of people covered and the country to which they belong is the world’s first, the vaccination age range is 18-60 years old, Good adaptability.

China has made great progress and breakthroughs in vaccine research and development. Judging from the comprehensive evaluation of various aspects of performance, in this COVID-19 pneumonia epidemic, China’s COVID-19 virus vaccine research and development results are excellent.

(source:internet, reference only)

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