How to ensure the safety of the world's top P4 biological laboratory?

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How to ensure the safety of the world's top P4 biological laboratory?

Time：2021-02-24 10:47:27 Source： Author：

Novel coronavirus pneumonia cases have been diagnosed in over 70 countries worldwide, especially in China, including the United States, India, Iran, Italy and Japan. There are many people in the world who are racing against time, not only patients, medical staff, but also biological scientists. The laboratory where they develop vaccines is their "battlefield.".

This kind of "battlefield" is very mysterious to most people, especially P4 laboratory, which has the highest biosafety level. Some data show that there are about 50 P4 laboratories in operation or under construction in the world, which are distributed in about 20 countries. P4 laboratory protects human health and safety, but its high-risk research often makes it fall into the criticism of biosafety and other issues. This time, Wuhan P4 laboratory was involved in the center of public opinion. What are the top virus laboratories in other countries like and how can they ensure their safety?

America: "we will not do anything in secret"

According to the statistics of the American Federation of scientists, there are 13 biosafety level 4 laboratories (P4 laboratories) in operation, expansion or planning in the United States, which are distributed in Georgia, Texas and other places. Some of them are owned by universities, and others are owned or managed by the Centers for Disease Control and Prevention (CDC), the military, the Department of homeland security, the state government, etc.

A Reuters reporter visited Galveston National Laboratory in Texas a few years ago. He described at that time that he followed the director to enter the only entrance of the laboratory by brushing the entrance guard, which was guarded 24 hours by the Texas police. In the corridor, more than 100 closed-circuit cameras were "staring" at him; You need to swipe another card to enter a research laboratory, and you need to scan fingerprints to enter a laboratory that stores particularly dangerous microorganisms According to reports, in order to test the safety, the laboratory and the FBI and other institutions jointly carried out simulation drills such as being intruded. Richard Albright, a virologist at Rutgers University in the United States, said that many of the preventive measures taken by the laboratory are not required by law, such as measures related to guarding, biological identification or video surveillance.

In practice, one issue could lead to controversy: which level of biosecurity measures should be used in the study, Reuters said. According to the regulations of the United States, P3 laboratory is suitable for the research on the causes of "serious or fatal diseases" but usually not human to human transmission, and such diseases usually have effective treatment or prevention methods, while P4 laboratory is suitable for the research on diseases without prevention or treatment methods.

For example, it took more than three years for the national emerging infectious diseases laboratory of Boston University to obtain the corresponding qualification approval procedure, which was upgraded from P3 to P4 by the end of 2017. Ronald Corley, head of the laboratory, said that every project they run is subject to continuous review and monitoring by a number of local and federal agencies, and that all the details of the research plan are open to the public. "We don't do anything in secret.".

The laboratory is located in Boston, where universities gather, and can make full use of a multidisciplinary team of experts. Virologist Paul Dupris has long studied measles and mumps viruses and is now working on Nipah virus. According to him, one advantage of the laboratory is that scientists can carry out Biosafety Level 2, level 3 and level 4 research work here at the same time. Researcher John Connor is an associate professor of microbiology. He collaborated with Galveston National Laboratory and the U.S. Army Institute of infectious diseases to develop diagnostic techniques for Ebola, Marburg and Lassa fever. These viruses are biosafety class IV viruses.

The U.S. Army Institute of infectious diseases, founded in 1969, is the most important defensive medical research unit under the U.S. Army, specializing in the research and development of defense methods for biological weapon operations. However, in July last year, the CDC found that the Institute did not have enough systems to purify the wastewater from Biosafety Level 3 and level 4 laboratory operations. At present, the Army Institute of infectious diseases is expanding. A new building covering an area of 77000 square meters will replace the crowded old office building, and it is planned to be put into use next year.

Laboratories funded by the U.S. government to study dangerous pathogens must comply with specific regulations to prevent microbial leakage, Reuters quoted experts as saying. If any of these laboratories violate the rules, the CDC will suspend funding. "But it can't shut down the lab." As a result, an American scholar said, he was "not so confident" in the biosafety of the United States.

According to a 2009 report by the Government Accountability Office, a congressional oversight body, 400 accidents occurred in P3 laboratories in the United States in the previous 10 years. Another data shows that from 1978 to 1999, about 1200 people in the world were infected by P4 laboratory virus, of which 22 were critically ill.

Experts deny the possibility of Hollywood disaster scenes, such as bombing a P4 laboratory to cause an outbreak. "Pathogens can self destruct in severe heat waves," says American biosafety threat scholar Ryan Salerno. "But as more of these studies are carried out, the risk of accidental leakage, potential theft and abuse will increase, especially at the international level." He believes that "science is far ahead of the government's ability to regulate science.". "We're in the middle of a P3 and P4 lab 'breeding' competition," said Laurie Garrett, a former senior researcher in global health at the Council on foreign relations. But the rapid growth of these laboratories has also allowed the world's most dangerous microorganisms to multiply without restriction. "

Germany: more than 20 procedures from entering to leaving the laboratory

There are four P4 laboratories in Germany. Not long ago, the reporter of the global times observed the P4 laboratory building of the Robert Koch Institute in Berlin, which is located next to the WILSHAW hospital campus of the largest teaching hospital in Europe, so as to make more effective use of the resources of both sides and reduce the risk of pathogen transportation. Charlotte medical school in Berlin is also a designated hospital for infectious diseases in Germany. The laboratory was put into operation at the end of July 2018, and visitors are generally refused. Reporters can only observe the internal situation from the glass wall outside the laboratory.

The head of the laboratory was interviewed by global times and other media reporters at an event last summer. He said at that time that the laboratory had separate ventilation, water supply and power supply systems, which could operate completely independently. The gas discharged from the laboratory also went through a multi-level filtration system to ensure the killing of possible pathogens.

The person in charge said that the relevant personnel need to go through more than 20 procedures from entering to leaving the laboratory, including entering the password, changing into protective underwear, wearing protective clothing and oxygen mask, walking through four gates, etc. when entering, they need to disinfect the protective clothing, take a shower, etc. During the experiment, no coffee or smoking, no whispering with others. Because once a staff member holds a sharp object such as a needle or scalpel, the risk of injury will increase. The laboratory also adopts the "four eye principle", that is, the work will be supervised by another staff member. If an employee has a fever, he / she must report it to the person in charge of the laboratory and a special doctor immediately, and then check the condition of the laboratory together.

The person in charge told reporters that only trained and experienced staff can work in P4 laboratory. All work must follow the prescribed procedures and be regularly checked by biosafety personnel of P4 laboratory. The P4 Laboratory of the Robert Koch Institute is licensed by the Berlin health and Social Welfare Bureau and other units, and is also supervised by relevant institutions and inspected regularly every year.

In the novel coronavirus pneumonia, University of Marburg, Germany, has been widely concerned for its important role in developing vaccines. The lab receives about 11 million 500 thousand euros per day per day. The famous Marburg virus is taken from its place name, because the virus was first discovered in this city. At present, under the leadership of Professor Becker, director of the Institute, the Institute has jointly developed a new vaccine platform with the German infectious disease research center. The platform adopts a modular design to speed up the matching of antigen and virus. Becker believes it will take at least a year to find a vaccine for the new coronavirus.

Focusing on the operation of virus laboratories, Germany has made detailed provisions on relevant measures in the "infection protection law", "Regulations on biological substances", "genetic engineering law" and other regulations. For example, only with permission can pathogens be used; protective measures must be taken to protect the safety and health of employees and prevent proliferation.

South Africa: Issue "Communique" every month to help the whole Africa

Africa has two P4 laboratories. One is located in Gabon, mainly serving French speaking countries on the continent; the other is the National Institute of infectious diseases of South Africa. Relying on the best medical conditions in sub Saharan African countries, it provides the South African government, SADC and even the whole Africa with knowledge of infectious diseases and assists in formulating coping policies.

The National Institute of infectious diseases of South Africa is located in Johannesburg, the largest city in the country. For example, Professor Lynn Morris, the interim executive director of the Institute, is an authoritative expert in the field of AIDS, and she is responsible for the development of AIDS vaccine. South Africa is one of the countries with the highest HIV infection rate in the world, reaching about 20%.

"Strive to provide global health services with the latest information and Research on infectious diseases from the African continent", which is the goal set by the Institute for itself. It publishes the Infectious Diseases Bulletin which provides the latest regional infectious diseases information every month. The partners of the National Institute of infectious diseases of South Africa include the World Health Organization, the African Center for Disease Control and prevention, etc.

It is an important part of the public health function of the National Institute of infectious diseases of South Africa to sound health warnings and issue epidemic reminders. Novel coronavirus pneumonia was first novel coronavirus pneumonia in Egypt in February 14th. After being checked out several times, the Institute immediately issued a reminder that it is recommended to return from all countries and regions where new crown pneumonia cases are reported to isolate themselves after symptoms.

However, as a national laboratory, the Institute's work efficiency and limited functions have also been criticized by the public. From 2017 to 2018, Listeria caused a public food safety crisis in South Africa. Thousands of people were infected by eating processed meat, and the mortality rate was as high as 20%. The case began to appear in January 2017, but it was not until March of the next year that the National Institute of infectious diseases of South Africa tracked down that the source of the disease was pork sausage produced by a South African enterprise, and the Ministry of health of the country was able to announce the recall of the problem food from domestic and foreign markets and suspend the production of related products. Who has warned that the outbreak caused by the outflow of toxic food from South Africa poses a threat to 16 other African countries, making it the largest ever recorded listeriosis outbreak in southern Africa.

According to South Africa's business daily, the outbreak exposed the local government's lack of power to obtain pathogen sample information from enterprises and private laboratories. At that time, only a quarter of the members of the NCC were willing to provide a list of contaminated foods. In addition, only two private food testing laboratories shared Listeria isolates that could be used for genome sequencing. Other institutions refused the request of the NCC on the grounds of confidentiality. After the incident, the South African government summed up the lessons and strengthened the legislation and enforcement of laws related to food safety.

In Lyon, France, there is one of the best virus laboratories in the world - the French National Institute of health and medicine Jean merieu P4 Laboratory (hereinafter referred to as Lyon P4 laboratory), which is dedicated to the study of highly pathogenic viruses and major hemorrhagic fever viruses. It is here that researchers confirmed in March 2014 that the Ebola virus ravaging West Africa should be Zaire type. In addition to studying the latest viruses, the P4 laboratory in Lyon has also conducted in-depth research, filing and searching for treatment methods for old and variant viruses in history.

From the appearance, the P4 laboratory in Lyon is located in a gray black building. The main building is divided into three layers: the upper layer is the air filtration area; the lower layer is the waste treatment area; the middle layer is the real core experimental area. Next to the main building, there is a two-story auxiliary building, which is responsible for experimental preparation and laboratory safety, all of which are controlled by the computer. In terms of safety, Lyon P4 laboratory provides a model and reference for many biosafety laboratories, including P4 laboratory in Wuhan. The laboratory adopts the structural design of "box in box", and its outer layer is made of glass and steel. It is considered as "the first creation of a new generation of four level biosafety laboratory". The inner layer of the laboratory is a sealed space with negative pressure, and the researchers breathe by independent oxygen supply system without contact with the outside air.

France has a certain advantage in the research and development of biological core technology and key equipment, so Lyon P4 laboratory has strong technical support. For example, the positive pressure work clothes used in the laboratory, whose head is a transparent inflatable hood, the lower end is connected with a breathing belt, and the other end of the breathing belt is suspended and connected to the pipe on the roof, so as to ensure that the scientific researchers can breathe in the protective clothing. Data show that this kind of protective clothing produced by delta protection company of France ranks first in the utilization rate of high-level laboratories in the world.

The laboratory was transferred to the French National Institute of health and medicine in 2005 and opened to the global scientific community. Research teams from different countries can apply to conduct relevant research in the laboratory. In recent years, with the support of government and private funds, the scale of the laboratory has been expanding. The scope of research not only covers almost all known virulent viruses, but also more detailed subject classification, covering pathogenic biology, virus host interaction and so on.

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