China.org.cn | January 4, 2021
Hu Kaihong:
Please welcome Chen Shifei, deputy head of the National Medical Products Administration (NMPA) for his opening remarks.
Chen Shifei:
Good morning, everyone. I would like to announce some good news: the NMPA has granted conditional marketing authorization for the inactivated COVID-19 vaccine developed by the Beijing Biological Products Institute Co., Ltd. under the China National Biotec Group (CNBG), which is affiliated with Sinopharm.
NMPA has been implementing General Secretary Xi Jinping's thought of putting people first. Under the strong leadership of the CPC Central Committee and the State Council as well as the coordination of the State Council's inter-agency task force, we established a mechanism for research and development of vaccines and drugs as well as emergency evaluation and approval system in the early stage of the epidemic. We have been taking a science-based approach, following legal procedures, and prioritizing the safety and efficacy of the vaccine. We reached out to R&D institutes, adopted a rolling review procedure, and made parallel progress in review, verification and testing to increase our efficiency in facilitating the marketing of a safe and effective vaccine.
Up to now, we have conducted over 5,500 discussions, consultations and research meetings with our R&D teams and expert panels in the development of vaccines and drugs. As Mr. Zeng has just said, we have authorized 14 vaccines to enter clinical trials. Five of them are now in Phase 3 clinical trials, including Sinopharm's inactivated vaccine. We are also facilitating several drugs in the pre-clinical trial stage.
As we all know, vaccines are an important weapon against epidemics, but their safety and effectiveness are always top priority. After the coronavirus outbreak, the National Medical Products Administration (NMPA) cooperated closely with the World Health Organization (WHO) and the medical products administrators of other countries, and exchanged information on vaccine research and development (R&D) and coordinated the standards of safety and effectiveness with them. On this basis, the Center for Drug Evaluation of the NMPA specially formulated five standards including technical guidelines for R&D of preventive vaccines against COVID-19, and made clear the technical standards for market access application and conditional market approval of vaccines against COVID-19, offering relevant references to the R&D and evaluation of China's vaccines against COVID-19.
In addition, the standards for COVID-19 vaccines are basically the same as those of the WHO and other countries, providing scientific support for China's vaccines to become a global public good. The Beijing Institute of Biological Products of China National Biotech Group on Dec. 23 formally submitted a registration application to the Center for Drug Evaluation of the NMPA for conditioned market access of its vaccine based on preliminary rolling submissions of research data. The center accepted it immediately. Its expert team conducted a comprehensive and detailed review of the safety, effectiveness and quality reliability, as well as other submitted research documents and data based on preliminary rolling reviews. The review covered pharmacological and toxicological research, phase I and II clinical trials, phase III clinical trials carried out overseas, and the Beijing Institute's pharmaceutical research data on large-scale production and quality control. The center also inspected the sites of domestic R&D activities and phase I and II clinical trials; however, we are unable to send experts overseas for on-site inspections of phase III clinical trials there due to the pandemic. It is mainly the research organizations that assume major responsibility in ensuring the integrity, authenticity and reliability of the research data. Our drug inspection institution also carried out trial remote inspections, a work that is never before carried out. We undertook remote inspections in response to inaccessible sites existing amid the pandemic.
Besides, the Center for Food and Drug Inspection of NMPA inspected the production sites of the Beijing Institute in accordance with the law. The Beijing Municipal Medical Products Administration reviewed its quality control practices in drug production. The National Institutes for Food and Drug Control conducted laboratory tests on and reexamined the quality of vaccine samples produced by the Beijing Institute in trial production. It also thoroughly reviewed the data of vaccine efficacy (79.34%) submitted and unveiled by the Beijing Institute according to interim results of the phase III clinical trials based on large-scale double-blind placebo-controlled analysis. It consulted a third-party expert team for their evaluation and suggestions on conditional market access, and the expert consultation meeting of the Center for Drug Evaluation for further opinions. After a series of rigorous inspections, examinations, evaluations, reviews, and data analysis in accordance with laws and procedures, we concluded that the known and potential benefits of the inactivated vaccine against COVID-19 of the Beijing Institute of Biological Products of China National Biotech Group were greater than the known and potential risks, completely meeting preset standards for conditional market access.
Amid the pandemic, over 80 million cases have been reported around the world, and a large number of patients are being hospitalized and many are passing away every day. There is no wonder drug against the virus available in the world yet. China is facing pressure from both potential local transmission and imported cases, so national medical products administrators can approve registration applications for conditional market access of the vaccines urgently needed in response to major public health emergencies in accordance with the Vaccine Administration Law of the People's Republic of China and the Pharmaceutical Administration Law of the People's Republic of China. Therefore, the NMPA approved conditional market access of the Beijing Institute's vaccine on Dec. 30. The NMPA is encouraging the company to continue its phase III clinical trials as planned in accordance with laws and regulations, complete them and other post-approval research with quality and quantity guaranteed, update and supplement vaccine instructions and labels in time based on research progress, data and results obtained, and absorbing study of abnormal reactions after inoculation, and apply to us for approval or filing in accordance with regulations.
The NMPA is engaged in a race against time in emergency evaluation and approval of vaccines and drugs and in proceeding with their R&D, while adhering to science-based principles and the premise of safety and effectiveness. We will ensure that the vaccines and drugs approved for emergency use by us are safe, effective, and reliable in quality, and make due contributions to the ultimate victory over the virus. Thank you.
Hu Kaihong:
Thank you, Mr. Chen. Now the floor is open to questions. Please identify your news outlet before raising questions.