Sinopharm Group CNBG's inactivated COVID-19 vaccine has been approved for conditional marketing!

The clouds and sails are high, the stars are racing day and night,

After countless trials and tribulations, it finally went public.

At 10:00 on December 31, the Joint Prevention and Control Mechanism of the State Council held a press conference to announce that the inactivated COVID-19 vaccine of Sinopharm Group China National Biotec Group has been approved for conditional marketing by the National Medical Products Administration. Xu Nanping, Vice Minister of Science and Technology, Zeng Yixin, Deputy Director of the National Health Commission and Head of the Vaccine R&D Team of the Scientific Research and Development Group of the Joint Prevention and Control Mechanism of the State Council, Chen Shifei, Deputy Director of the National Medical Products Administration, Shen Bo, Head of the International Department of the Ministry of Foreign Affairs, Mao Junfeng, Head of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology, Zheng Zhongwei, an expert of the Vaccine R&D Team, and Wu Yonglin, President of Sinopharm Group China National Biotec Group, introduced the relevant situation of the COVID-19 vaccine and answered questions from reporters.

At the press conference, Chen Shifei, deputy director of the State Food and Drug Administration, announced that on December 30, the State Food and Drug Administration conditionally approved the registration application of the inactivated new coronavirus vaccine of Sinopharm Group China National Biotec Group Beijing Institute of Biological Products in accordance with the law, which is what people usually call conditional marketing.

Wu Yonglin, President of Sinopharm Group China National Biotec Group, answered questions about the clinical data and antibody durability of Sinopharm Group China National Biotec Group's inactivated COVID-19 vaccine that are of public concern.

About vaccine protection

Sinopharm Group China National Biotec Group's COVID-19 vaccine has undergone large-scale Phase III clinical trials in many countries including the UAE and Bahrain. The number of vaccinations has exceeded 60,000, and the sample size of the vaccinated population covers 125 nationalities. The evaluation of the interim protection rate data has been completed. The current results are better than the predetermined goals of the clinical research. The safety and effectiveness indicators exceed the World Health Organization's standards for marketing and the requirements of the conditional marketing work plan approved by our country, and can provide effective protection for a wide range of people.

On December 9, the UAE Ministry of Health and Prevention approved the registration and listing of Sinopharm's inactivated COVID-19 vaccine, which is the world's first officially approved COVID-19 vaccine. On December 13, the Bahrain National Health Regulatory Authority also approved the registration and listing of Sinopharm's COVID-19 vaccine. The clinical trial data review results show that the vaccine is 86% effective. The UAE and Bahrain are both members of the World Health Organization, and their drug and vaccine regulatory systems and registration and listing standards are in line with relevant international standards.

The country also approved the conditional marketing approval on December 30. The interim analysis of the Phase III clinical trial of the Sinopharm China National Biotec Group COVID-19 vaccine, reviewed and approved by the National Medical Products Administration, showed a protective efficacy of 79.34%.

There are differences in case diagnosis standards and processes among countries. The 86% protection efficacy approved by the UAE and the 79.34% protection efficacy data approved by the China Food and Drug Administration are both true and valid. The analysis data in the UAE and China are also consistent. For example, the neutralizing antibody conversion rate is above 99%, and the protection rate for moderate and severe cases is reliable. The vaccine is very safe and effective.

About antibody persistence

Sinopharm Group China Biological conducted Phase I and II clinical studies in China and Phase III clinical studies abroad, and both conducted continuous observations of antibodies. According to the data of Phase I and II studies of the new crown inactivated vaccine, antibodies can still be maintained at a high level for more than 6 months. The UAE and Bahrain reviewed and approved the formal registration and listing of Sinopharm Group China Biological's new crown vaccine in accordance with the relevant technical standards of the World Health Organization. The results of the clinical trial data show that the protective data results have reached the predetermined goals and meet the requirements for listing. At present, clinical studies in China, the UAE, Bahrain, Egypt, Jordan, Peru, Argentina, Morocco and other countries are still ongoing, and the persistence of antibodies will continue to be observed. According to our country's conditional listing work plan and the relevant technical standards of the World Health Organization, the protective data results currently observed have reached the predetermined goals and meet the requirements for conditional listing.

Because the COVID-19 vaccine is an innovative vaccine, its durability and protective effect still need to be observed for a longer period of time. We believe that as the Phase III clinical trial continues to advance, we will obtain and publish long-term protective data.

About COVID-19 vaccine production capacity

The high-level biosafety production workshops for the inactivated COVID-19 vaccine built by Sinopharm Group China National Biotec Group in Beijing and Wuhan have been put into large-scale production after inspection and certification by relevant national departments. The Beijing production base has a designed annual production capacity of 120 million doses and is currently under expansion. It is expected that the production capacity will reach 1 billion doses next year. In accordance with relevant deployment requirements, China National Biotec Group will also coordinate the layout to further expand production capacity to better meet demand.

How to objectively evaluate the inactivated COVID-19 vaccine

Comprehensive evaluation of a vaccine should consider safety, effectiveness, accessibility, affordability and other major factors. In the face of a major epidemic that humanity has not seen in a century and the urgent need for effective vaccines in global public health events, the evaluation of an innovative vaccine for all ages and healthy people requires taking into account various factors and conducting systematic and comprehensive considerations. Safety is the first condition to be considered. Under the premise that the safety of the vaccine is acceptable, effectiveness is a very important indicator. In addition, specific factors such as the vaccine's production capacity, storage, transportation conditions and scope of use should also be considered.

The inactivated COVID-19 vaccine developed by Sinopharm Group China National Biotec Group has good safety, and its effectiveness data exceeds the preset goals of clinical studies. The cold chain storage and transportation conditions are in line with the national conditions of most countries in the world, and the production capacity is sufficient to meet large-scale vaccination needs.

On December 30, the Beijing Institute of Biological Products, China National Biotec Group, announced the interim analysis data of the Phase III clinical trial of the inactivated new coronavirus vaccine. The Phase III clinical trial of the inactivated new coronavirus vaccine of China National Biotec Group was a randomized, double-blind, placebo-controlled, multi-center clinical study. Clinical data showed that the inactivated new coronavirus vaccine of the Beijing Institute of Biological Products had good safety after vaccination. After two injections of the immunization program, all vaccine group recipients produced high-titer antibodies, and the neutralizing antibody positive conversion rate was 99.52%. The vaccine's protective efficacy against diseases caused by new coronavirus infection (COVID-19) was 79.34%. The data results met the relevant technical standards of the World Health Organization and the relevant standard requirements in the "Guidelines for Clinical Evaluation of New Coronavirus Vaccines (Trial)" issued by the National Medical Products Administration.

The Phase III clinical study of the inactivated COVID-19 vaccine of Sinopharm Group China National Biotec Group has received strong support from the Joint Prevention and Control Mechanism of the State Council, the Scientific Research Team, the Vaccine R&D Team, the State-owned Assets Supervision and Administration Commission of the State Council, the National Health Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the National Medical Products Administration and other relevant departments, as well as close cooperation from the Institute of Viral Disease Prevention and Control of the Chinese Center for Disease Control and Prevention, the Wuhan Institute of Virology of the Chinese Academy of Sciences and other units. With the great help of the governments of the United Arab Emirates and other countries and the Chinese embassies and consulates abroad, and under the guidance of experts from the Chinese Center for Disease Control and Prevention and the Henan Provincial Center for Disease Control and Prevention, the clinical teams of Henan Center for Disease Control and Prevention, Sinopharm Group, Sinopharm International, China National Biotec Group and the United Arab Emirates and other countries have worked selflessly and made contributions together.

The conditional approval of the new crown vaccine for marketing will inject confidence into the world's fight against the epidemic, provide strong support for the accessibility and affordability of the new crown vaccine as a global public product, and make China's contribution.

Starting from the Phase III clinical trial enrollment,

Until the COVID-19 vaccine is conditionally approved for marketing,

It only took 168 days!

Protect health, love and responsibility,

Come on for the world, come on for humanity!