Sinochem Vaccine Is Authorized By Who For Emergency Use, And National Medicine Will Supply Vaccine To Covax Soon

        The World Health Organization (who) announced on June 1, local time that it had released the new inactivated coronal vaccine kelefu developed by China Kexing Zhongwei (a subsidiary of Kexing Biology) ® Included in the "emergency use list". This is the second section of China's new crown vaccine authorized by who for emergency use after the new crown vaccine developed by sinopharma Group China biology Beijing Institute of biological products was included in the "emergency use list".

        On the same day, the first batch of covax (New coronal pneumonia vaccine implementation plan) of Sinopharm Group China biological Beijing Biological Products Research Institute was offline.

In the view of industry insiders, Sinopharm and Sinochem's new coronal vaccines are authorized by who for emergency use, which will help to improve the accessibility and affordability of new coronal vaccines in the world, especially in developing countries. It also means that the quality, safety and effectiveness of China's new crown vaccines meet the requirements of relevant WHO standards, This will enhance people's trust and willingness to vaccinate in China. China's new crown vaccine industry is fulfilling the mission of "global public goods".

The 21st century economic report reporter learned from Kexing biology that as of May 31, Kexing holdings had supplied more than 600 million doses of new coronal vaccine to China and nearly 40 countries and regions around the world, and global vaccination of kelifor ® Over 430 million doses. Of the new coronal vaccines administered worldwide, one dose in every five doses is kleyfour ®。

Inclusion in the WHO emergency use list

Since the application for inclusion in the emergency use list was formally submitted to who at the end of 2020, ZTE Zhongwei has successively submitted clinical research data, non clinical research data, quality and pharmaceutical research data according to the requirements of who, so as to evaluate the quality, safety, protection effectiveness data and risk management plan of the vaccine. In February 2021, who inspection team carried out on-site inspection on the production line of Zhongwei Xinguan vaccine in Kexing. On April 29, 2021, who's strategic advisory expert group (SAGE) made a visit to kelifor ® After systematic review, it is considered that the benefits of using the new crown vaccine of Sinovac are greater than the known risks, and the use of this vaccine is recommended.

The WHO emergency use list procedure is a technical review procedure to include new products or products that have not passed the pre certification into the scope of procurement in response to public health emergencies. After the outbreak of the new global outbreak, who revised the emergency use listing procedure, which became a prerequisite for all countries to provide vaccine for covax. Covax is a project jointly initiated and led by the global alliance for vaccines and immunization (GAVI), the World Health Organization (who) and the Alliance for innovation in epidemic prevention (iuepi). It aims to accelerate the development and production of new coronal vaccines and to ensure that each country has fair access to the new coronavirus. In October 2020, China signed an agreement with GAVI to formally join the program.

Tao Lina, a vaccine expert, said that through the emergency use list (Eul) process, it also means that Kexing will soon start to supply its new crown vaccine to covax.

On June 1, the first batch of covax new coronal vaccine provided by Sinopharm group in China was officially offline. According to Wang Hui, director of the Beijing Institute of biological products, the new crown vaccine, which is off-line, is packaged in English; Second, as the first new crown vaccine with a vaccine bottle monitor, the VVM label on the vaccine bottle can monitor the temperature change of the surrounding environment, so that health workers can judge whether the vaccine is safe and available. This technology has also been affirmed by who; Third, the outer package of the vaccine is specially printed with two-dimensional code for international supervision; Fourth, the instructions of the vaccine were supplemented and improved at the request of the World Health Organization.

Yuan yuan, national representative of pasar Shanghai Representative Office and head of business and business development, told 21st century economic reporter that after domestic vaccines were included in the Eul, vaccines could be provided to more countries through covax. This will not only promote the international development of China's vaccine industry, but also improve the fair distribution of global vaccines.

Once again, the vaccine in China is safe and effective

Yin Weidong, chairman, President and CEO of Kexing biological Co., Ltd., said that Kelaifu of Zhongwei Group Co., Ltd ® Phase III clinical studies and follow-up real-world studies conducted in Brazil, Turkey, Indonesia and Chile have laid a solid scientific foundation for its application in more than 40 countries and regions around the world and the recognition of who.

On April 16, local time, Chile's Ministry of health released the Kexing Zhongwei inactivated vaccine kelefu ® Real world data on nationwide vaccination in Chile. The Chilean government conducted a follow-up study of 10.5 million people registered in the health system, comparing the results of new coronavirus infection among people who had received one or two doses of new coronavirus vaccine with those who had not.

The report points out that two doses of kleyfour were inoculated ® After 14 days of vaccination, the effective rate was 67%, the prevention rate of hospitalized cases was 85%, the prevention rate of severe cases was 89%, and the prevention rate of infection death was 80%.

In terms of the prevention of symptomatic new coronavirus, kleyfour ® The protective effect was only 16.1% in some vaccinated population and increased to 67.0% in complete vaccinated population; In the aspect of prevention and hospitalization, the efficacy of some vaccinated population was 35.7%, while that of complete vaccination population was increased to 84.8%; In the aspect of prevention of entering ICU, the efficacy of some vaccinated population was 42.7%, and that of complete vaccination population was 88.6%.

Just on June 1, Kexing biological also released the data on the vaccination effect of Brazil's "plan s": the death toll will be reduced by 95%, and the vaccination rate of 75% can curb the spread of the virus. Meng Weining, deputy general manager of Sinotrans, told the 21st century economic reporter that celana is a town in Sao Paulo state of Brazil, with a total area of 125.744 square kilometers and a population of 45000. It was one of the areas with the highest infection rate in Sao Paulo state. It is reported that 5% of the people have persistent infection and spread to other people, and there is a P.1 mutant epidemic, so it is the first pilot city of the study.

The efficacy and safety of the two vaccines of China biology have also been confirmed by clinical trials.

On May 26, 2021, the Chinese biological research team published the results of the world's first phase III clinical trial of the new crown inactivated vaccine in "JAMA". The results showed that after 14 days of inoculation, the two new crown inactivated vaccines produced high titers of antibodies and formed effective protection, and the neutralization antibody positive conversion rate of the whole population was more than 99%. The protective effect of wiv04 vaccine group was 72.8%, and that of HB02 vaccine group was 78.1%. The safety is good, the side effects are mostly injection site pain, mild degree, transient and self limiting.

Esper kallas, a professor of infectious diseases at the University of Sao Paulo, said that the vaccination against kleyfour ® After that, the number of cases decreased significantly and was not limited to those who received two vaccinations. This not only confirms the results of phase III clinical trial, but also conforms to the view that virus transmission can be controlled by large-scale use of vaccine.

Professor Wang Xuanyi of the Biomedical Research Institute of Fudan University said: Brazil is still in the epidemic of P.1 variant, and the average coverage rate of vaccine in the whole country is about 15%. Serrana, one of the 16 districts in Sao Paulo state, has about 30000 people. A cluster randomized trial showed that the vaccine coverage reached 98%. The existing data can be summarized as follows: first, the incidence of severe illness (hospitalization and death) in serana decreased rapidly after the second dose of vaccine was started; However, this trend was not found in other areas with low vaccine coverage in Sao Paulo; Secondly, in 2% of the non vaccinated population, there was still a small peak after the completion of two doses of vaccination in the whole town of selana, while there was no similar peak in the population who completed the two doses of vaccination, which showed the protective effect of vaccination.