The world's first Sabin strain polio inactivated vaccine was approved for marketing
January 15, 2015
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On January 14, 2015, the State Food and Drug Administration approved the registration application for the production of the world's first Sabin strain polio inactivated vaccine (single seedling). The vaccine was developed by the Institute of Medical Biology of the Chinese Academy of Medical Sciences. The strain was produced by using the current live poliovirus attenuated vaccine (Sabin strain), and the virus was harvested in the Vero cell bioreactor to combine the inactivated vaccine production process. Prepared. The vaccine is mainly used for the prevention of poliovirus infection in children through injection. Its listing will play a vital role in the complete elimination of polio in China.
Polio is an acute infectious disease caused by poliovirus type I, II and III. It is also the second infectious disease that humans intend to eliminate after the smallpox. The promotion of its elimination plan has been included in the World Health Organization. One of the most important tasks at present. Currently, countries mainly use the polio inactivated vaccine for injection (IPV) and the oral Sabin strain polio attenuated live vaccine (OPV) for prevention. Since polio attenuated live vaccination is simple, low cost and easy to transport, since 1963, most countries in the world have adopted it as the main means of immune prevention. The prevention and control of polio in China began in the 1960s. By promoting the live attenuated polio vaccine in the country, it has effectively controlled the occurrence of the disease. In 2000, China was recognized by the World Health Organization as a country without polio.
Although the polio attenuated live vaccine is highly immune and has a long duration of action, it is still a potentially attenuated disease because it is a live attenuated vaccine. Sometimes it can directly trigger related cases of vaccine strains, or vaccine strains. The cyclically formed derivatives elicited related cases. Although the incidence of this situation is extremely low, only about 1 / 25,000 - 1 / 5 million, but if the polio attenuated live vaccine is used alone, the World Health Organization in the final phase of the polio eradication strategic plan (2013- The parallel goal of eradicating poliovirus and eradicating poliovirus-derived poliovirus proposed in 2018) cannot be achieved. The use of polio inactivated vaccines can avoid this. Therefore, the replacement of live attenuated vaccines with polio inactivated vaccines will be the only way to eliminate polio worldwide.
At present, only a few foreign companies use poliovirus to produce polio inactivated vaccine, and their products are widely used in developed countries. One of the products of the company is listed as a second-class vaccine in China, but the quantity is limited and the price is high. In order to ensure that the country’s commitment to polio eradication to WHO is fulfilled, it is expected that the annual vaccination demand for polio inactivated vaccine will reach tens of millions of doses each year. As a major innovative product with completely independent intellectual property rights in China, the approved Sabin strain polio inactivated vaccine successfully achieved the progress of China's vaccine from “Made in China†to “Created in Chinaâ€. It not only fills the gap in the field of polio inactivated vaccine production in China, but also breaks the monopoly of polio inactivated vaccine production technology in developed countries, and it will produce polio eradication in China and even in the world, especially in developing countries. positive influence. It is understood that the vaccine will be gradually incorporated into our planned immunization program. The World Health Organization also recently sent a letter to the relevant departments of China to propose the introduction of the Sabin strain polio inactivated vaccine produced in China into the global action plan for eradicating polio.
In the process of registration and evaluation of the vaccine, relevant organizations and departments at home and abroad have given high attention. As the world's first Sabin strain polio inactivated vaccine (single seedling), its review and registration work is difficult, influential and responsible. In order to comprehensively evaluate the safety and effectiveness of the innovative vaccine, the State Food and Drug Administration has scientifically deployed and coordinated arrangements, and all relevant units have worked closely and seamlessly to optimize workflow and improve work efficiency under the regulatory framework. Follow-up, “open door reviewâ€, forward-looking guidance, and program linkage ensure that the technical review, on-site inspection, inspection and inspection, and administrative examination and approval are completed efficiently, fairly, and transparently. The technical department of our bureau adheres to the concept of scientific supervision and open vision, and conducts professional review according to procedures. It has held many expert seminars and consultation meetings, and invited the World Health Organization and the US CDC, Japan NIID, EU EMA, UK NIBSC and other international organizations. Representatives and experts, as well as national health and family planning committees and experts and business representatives in the field of infectious disease prevention and control and vaccine research and development in China, participated in the discussion and review. On the basis of fully drawing on the experience of research and development and evaluation of innovative drugs at home and abroad, all relevant departments have strictly checked and ensured the scientific, objective and comprehensive registration and review work.
Tips
1. What is the current progress in the global elimination of polio and the control of polio in China?
In the mid-1980s, due to the implementation of the Expanded Immunization Program (EPI), the global routine immunization rate increased rapidly. In 1988, WHO launched the Global Polio Eradication Campaign, which aims to eradicate polio globally in 2000. With the joint efforts of all countries in the world, the number of new polio patients in the world has decreased from 350,000 in 1988 to more than 1,000 in the end of the 20th century. On May 26, 2012, the World Health Assembly proposed to develop and implement the Strategic Plan for the Final Stage of Polio Eradication (2013-2018). The program also pursues two parallel targets of eradicating poliovirus and eradicating polio-derived poliovirus, and intends to remove type II strains from conventional live attenuated vaccines for trivalent polio. The premise of this immunization strategy adjustment is that the bivalent vaccine containing the live attenuated polio vaccine type I and III and the polio inactivated vaccine must be marketed, and the altered immunization program should include at least one needle of polio inactivation. vaccine.
China's polio prevention and control began in the 1960s, and the promotion of oral polio attenuated live vaccines nationwide has achieved great results. In September 2000, China was recognized by the World Health Organization as a country without polio. Despite this, China's polio-free work remains challenging. As of the end of 2012, there are still three countries with polioviruses in the world, and two of them border China. In August 2011, China discovered an imported poliovirus outbreak in Xinjiang, and the strain was imported from Pakistan. Due to timely disposal and sufficient supply of live polio attenuated vaccine products, the epidemic was quickly controlled and China returned to a state of no polio, but this crisis also sounded the alarm for polio prevention work in China.
2. What is the difference between polio inactivated vaccine (IPV) and live polio attenuated vaccine (OPV)? What are the advantages and disadvantages of each?
Polio is an acute infectious disease caused by poliovirus types I, II and III. Before the successful development of the vaccine, almost all children were exposed to poliovirus, and in 200 poliovirus-susceptible children. There was a case of paralytic polio. Around 1953, the first injectable polio inactivated vaccine (IPV) containing three serotypes was developed by the Salk isolate of the University of Pittsburgh, USA. The vaccine passed the largest on-site protective effect test at that time, in 1955. Approved for listing in the United States. Since then, many developed countries have widely used wild-type vaccines from Salk, and have blocked the spread of wild poliovirus in four Nordic countries: Finland, Iceland, the Netherlands, and Sweden.
At the same time, Albert Sabin of the University of Cincinnati is also conducting research on polio vaccines. Unlike polio inactivated vaccines, Albert Sabin subcultures poliovirus until a less virulent strain is screened, and the resulting vaccine is called oral polio attenuated live vaccine (OPV). The development of a live attenuated vaccine for Sabin was awarded the Nobel Prize in Medicine in 1965. Due to its simple inoculation and low cost, it is easier to transport than polio inactivated vaccine. Therefore, since 1963, most countries have replaced the inactivated vaccine with the live attenuated vaccine (Sabin strain) as the main immunoprophylaxis. .
However, the live attenuated polio vaccine still has certain safety problems. In addition to the relevant cases that directly trigger the vaccine strain, the derivative strains formed by the circulation of the vaccine strain can also cause related cases. In addition, a small number of immunodeficiency patients will become carriers of vaccine-derived poliovirus after using a live attenuated vaccine, and they will prolong the virus to cause disease transmission. The monitoring statistics in recent years show that the number of cases caused by the live attenuated vaccine against type II polio has exceeded the number of cases caused by wild strains and has become a major problem affecting the children's population. The use of inactivated polio vaccines can completely eliminate viral infections caused by live attenuated vaccines and the risk of disease outbreaks caused by vaccine-derived poliovirus cycles.
It can be said that the live attenuated polio vaccine is a powerful weapon for humans to fight against the polio virus that has been widely abused; and the polio inactivated vaccine is the current polio virus that is almost endangered by humans. The only choice for fighting annihilation.
3. What is the current situation of polio vaccines listed and being developed in China?
In China, the polio vaccines produced and used have a type I, II, III monovalent oral polio attenuated live vaccine and an I+II+III oral polio attenuated live vaccine. Since 1965, China has used the monovalent polio attenuated live vaccine. It was discontinued in 1985 and replaced with a full-fledged trivalent vaccine. The basic immunization procedures for vaccination were: 2, 3, 4 months, and 4 years old. ?
For the conventional immune supply capacity, the main producers of live polio attenuated vaccines in China are the Institute of Medical Biology of the Chinese Academy of Medical Sciences and Beijing Tiantan Biological Company. These two companies have only produced polio trivalent vaccines (sugars) in recent years. Pills and oral liquid dosage forms, mainly based on sugar pills, can fully meet the national immunization needs.
Before the birth of the Sabin strain polio inactivated vaccine, there were no polio inactivated vaccine manufacturers in China. The imported products are only inactivated by the Sanofi Pasteur Company's Salk strain in China (2009), which are IPV single seedlings and Baibai Break-B Haemophilus influenzae-polio vaccine. (五è”è‹—). The above vaccine is marketed as a second class vaccine.
At present, in addition to the approval number of the polio inactivated vaccine for Sabin strain, the Institute of Medical Biology of the Chinese Academy of Medical Sciences, Beijing Tiantan Biological Products Co., Ltd., Beijing Kexing Biological Products Co., Ltd. and Beijing Minhai Biotechnology Co., Ltd. are also in progress. Development of the Sabin strain polio inactivated vaccine.
4. What is the difference between the approved Sabin strain inactivated vaccine and the traditional inactivated vaccine? Why is it a milestone in the eradication of polio in China?
To ensure that our country’s commitment to WHO to eradicate polio is fulfilled, polio inactivated vaccines will be gradually introduced into immunization programmes, with tens of millions of doses per year. If there is no self-produced polio inactivated vaccine product, the Chinese government will face the problem of guaranteeing supply in addition to the huge pressure on procurement funds.
According to the WHO's plan to eliminate polio, the current management of poliovirus strains is extremely strict. Except for the traditional inactivated vaccine manufacturers in a few developed countries, wild strains are no longer allowed to be imported into any other country for research and development. Or production. In other words, it is impossible for a country that does not have a wild-type vaccine inactivated vaccine company to develop and produce such a vaccine independently. Currently, no developing country in the world has a company that can independently produce polio-inactivated vaccines. . Therefore, for China, to meet the domestic demand for polio eradication, there is no alternative to self-reliance and innovative research and development.
The approved Sabin strain polio inactivated vaccine was independently developed by the Institute of Medical Biology of the Chinese Academy of Medical Sciences. It is the first approved polio inactivated vaccine (single seedling) in China and the world's first Sabin strain. The product avoids the bottleneck of the wild strain, and adopts the current strain of polio attenuated live vaccine to produce the virus by culturing the virus in the Vero cell bioreactor, combined with the inactivated vaccine production process, mainly through injection. The route is used to prevent poliovirus infection in children. As a major innovative product with complete independent intellectual property rights in China, the Sabin strain polio inactivated vaccine has successfully realized the progress of China's vaccine from “Made in China†to “Created in Chinaâ€. It not only fills the blank of China's polio inactivated vaccine production, but also becomes a milestone in China's eradication of polio. It also breaks the monopoly of polio inactivated vaccine production technology in developed countries, especially for China and even the world. It is a positive impact of the eradication of polio in developing countries. It is understood that the vaccine will be used in the planned immunization program in China. In the near future, WHO also sent a letter to the relevant departments of China to propose the introduction of the Sabin strain polio inactivated vaccine produced in China into the global action plan for eradicating polio.
5. What regulatory measures will be taken to ensure public safety after the vaccine is marketed?
For the newly approved vaccine, the manufacturer is required to formulate a post-marketing security alert plan at the time of approval, paying close attention to the safety of large-scale population vaccination after the listing, while continuing a series of post-marketing research and data collection; The drug regulatory agency conducts daily supervision of vaccine production and strictly regulates the production behavior of the enterprise; the third is to issue the batch of products to be listed for production, pass the procedures of production data review and laboratory inspection, and then issue the corresponding certification documents for qualified products before they can be listed. The fourth is to manage the vaccine business license, requiring vaccine manufacturers and business units to strictly implement the relevant provisions of electronic drug supervision, and conscientiously do a good job in network access, code assignment, and nuclear capital verification, to ensure the source monitoring and traceability of vaccines. Sex. The fifth is to strengthen the monitoring of adverse drug reactions and monitor the adverse reaction data related to vaccine vaccination in real time. In addition to routine supervision, the national food and drug regulatory authorities will also follow the needs of flight inspection, market sampling and other means to track the production and product quality of enterprises to ensure the safety of public medication.
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