The extension of the coronary virus epidemic has made the global desire for vaccine a syndrome of vaccine anxiety or vaccine desire.Several facts and phenomena reflect this, and may cause greater problems and trouble.
Russian Minister of Health said on August 1 that Russia plans to start large -scale vaccines in October.On August 11, President Putin announced that the vaccine satellite V (SPutnik V), developed by the Gamaleya Institute, developed by the Gamaleya Institute of Popular Diseases and Microbiology, has passedAll necessary testing is proven to be effective and can cause the human body to form continuous immunity; the Russian Ministry of Health has approved the world's first crown vaccine.
Although the Russian vaccine was approved and registered by the official (health department), it was the first official -type vaccine, but only after two phases of clinical trials, it did not go through the third phase of clinical trials.His doubts have not been recognized.
Recently, there are also media reports that a few people in China have vaccinated the coronary vaccine of a biological company, 1,000 yuan and two stitches. Most of the vaccination groups are special groups, such as often travel abroad and related personnel of some medical institutions.However, the current vaccination is not targeted at individuals, and only contacts with the unit.As for how long the vaccine protection period is, and whether it is 1,000 yuan or two stitches, it cannot be confirmed.
Even if a few people in China have been vaccinated with coronary diseases, they are not vaccines that have undergone three phases of clinical trials, but only two phases of clinical trials.According to WHO's data, of the 165 types of coronary vaccines for research and development of the register, 139 types are in the early stages of research and development, 26 types enter the clinical test stage, of which there are three types in China, two types of the United States, and one vaccine in the UK has entered the number one.Third stage test.The three types of vaccines in China are inactivated viruses. The United States is a nucleic acid vaccine, and the British vaccine is a non -replicable virus carrier.
Gold standards for assessing vaccine drugs
Obviously, even the three vaccines in China are only undergoing three phases of clinical trials, and the test results have not been obtained.Therefore, the crown vaccine injected by someone is only the vaccine after obtaining the results of the second phase of clinical trials.In the six candidate vaccines that have been recognized by WHO, they do not include Russian satellite V.
After more than 100 years of exploration, modern medicine has a golden standard for the safety and effectiveness of vaccines and drugs, that is, large -scale random dual -blind control research; specifically reflected that each drug and vaccine must be advanced to animals.Tests also need to conduct three phases of clinical trials, and after obtaining safety and effective results in order to obtain approval and listing from the national health department, and be recognized by WHO.
The first phase of the clinical trial focuses on observing the safety of use. It mainly uses a few susceptible health volunteers as a subject to determine the human body's tolerance to different doses of vaccine, and understand its preliminary effectiveness and security.The subjects at this stage need about dozens or 100 people.
The second phase of clinical trials are the expansion of the sample volume and target group. It is a result of the preliminary effectiveness and safety of the vaccine in the crowd. It is further confirmed, and the immune program and immune dose must be determined.This period generally requires hundreds of subjects, or even more.
Only the third phase of clinical trials can truly determine the effectiveness of the vaccine, but more subjects are needed, generally thousands of, or even tens of thousands to determine whether the vaccine is effective.
Now, regardless of Chinese and foreign, people are anxious to vaccinate vaccines that have been vaccinated by the second phase of clinical trials, which are challenges to modern medicine on the development and use of gold standards for vaccines and drugs.There is no one standard in science and can accept challenges. If there are better standards, you can replace the old standards.However, it seems that the result of the three -phase clinical trial standards of the challenge is still unknown, so it contains a certain crisis, even a major crisis.
This challenge first comes from the global anxiety about crown diseases, eager to end the epidemic as soon as possible, and people can return to normal life and economic development track.The impact of the epidemic on people's normal life. In addition to preventing and restricting shopping, catering, tourism, entertainment, etc., the employment rate, economic growth, and stock market are more obvious in terms of economy.In terms of unemployment rate, the impact of crown disease has been unprecedented for more than 100 years.
According to data from the International Monetary Fund (IMF), as of June 29, 2020, the unemployment rates in Italy, France, and the United States were the highest in the world, with 12.7%, 10.4%, and 10.4%, respectively.For the United States, it has also ended its 10 -year economic expansion and growth.
Faced with such a predicament, the world has put hopes on vaccines. At least in terms of people's cognition and psychology, you can live and work normally when you vaccinate the vaccine.Employment rate improvement and economic recovery.Therefore, it is not surprising that some people are willing to vaccinate only the second -stage clinical trial.
On the other hand, some countries need to challenge the golden standards of the third phase of clinical trials of vaccines and drugs, which is also to reflect the country's scientific research capabilities and competitiveness.This is obviously like this.It can be seen from the vaccine that is only a satellite V or Spitnick 5 from the vaccine that is only a clinical test.
Spetenick No. 1 was the first artificial satellite that entered the planet track at the Bykoner Space Center on October 4, 1957.This artificial satellite was successfully launched in a preceding, which not only shocked the West, but also caused a series of incidents in the United States, such as the Sprintnik crisis and the small stocks of Wall Street.Essence
Sympathy for drugs and vaccines
Of course, the use of the second phase of clinical trial vaccine has a more important reason and basis, that is, the use of the sympathy of drugs and vaccines, also known as Expanded Access (Expanded Access), refersPatients who lack alternative therapy for the treatment of the treatment can be effectively treated when they cannot obtain effective treatment through the clinical trials that have been listed or admitted or admitted.
In 1997, the Food and Drug Management Modernization Law released by the US Food and Drug Administration (FDA) incorporated sympathy in it, allowing patients with severe or life -threatening, and patients with no suitable alternative treatment.Research drugs that should be obtained in addition to clinical trials.In 2016, the 21st Century healing bill passed by the US Congress made detailed provisions on the rights and obligations of drug developers: drug developers have the obligation to disclose sympathy for drug policy information to the public in a timely manner;right.
Chinese law also allows sympathy.In 2019, the newly revised Drug Management Law stipulates that drugs that are conducting clinical trials that are used to treat serious life and have no effective treatment of diseases may benefit from medical observation and meet ethical principles.After informed consent, it can be used in institutions that conduct clinical trials for other patients with the same condition.
However, the current use of sympathy is mainly aimed at drugs and clinical treatment technologies regardless of Chinese and foreign, and there is no regulation for vaccines.However, at this stage in China, some people used vaccines that only passed the second phase of clinical trials. In fact, they were sympathetic to expand to the vaccine.In Russia, this sympathetic use or even official recognition, that is, the vaccine after the second -stage test can be officially registered and approved, becoming a vaccine allowed by law.
However, the sympathy of the vaccine must also be ethically reviewed, and the parties should be informed. Even if the official registration and approval are approved, it must go through this link.Of course, more importantly, whether the vaccine that only passes through the second phase of clinical trials can replace the vaccine that can be replaced by clinical trials, it is the focus of today's vaccine anxiety.
If the situation in Russia and China proves that the vaccine after the second phase of the clinical trial is safe andValid, then those that have been identified in the past must be changed through the three -phase clinical trial vaccine and drug development and use of drugs, which can be changed. In fact, it can also overtake the curve, greatly reducing the time and cost of vaccine and drug development, which is conducive to human society.
However, for the three -phase clinical trial principles of challenging vaccines and drugs, WHO shows great uneasiness and disagreement.Tarik Jasarevic, a spokesman for the organization, said that accelerating the progress of vaccine development cannot be at the expense of the safety and effectiveness of the sacrifice of vaccine.At the same time, Michael Ryan, the executive director of WHO's public health emergency plan, said that the side effects of the vaccine will become obvious only when many people are vaccinated.
Therefore, even if we start to vaccine in a wide range of people, we still need a monitoring stage.There are no shortcuts here.I think many experts in the United States, including the Director of the Institute of Allergies and Infectious Diseases, and others have said this.When we consider risks, we should not pay attention to the financial issues on one side, but should consider more security factors.
Therefore, the anxiety of the vaccine is reflected in the vaccine that has been vaccinated only through the second phase of clinical trials. It is hoped that this will not cause serious and large number of vaccine side effects, and even destroy the reputation of the vaccine and the process of anti -crown disease in the future.
The author is a Beijing scholar
The anxiety of the vaccine is reflected in the vaccine that has been vaccinated only after the second phase of clinical trials. It takes time and practice to test it. We can wait and see.However, I hope that there are no serious and large number of vaccine side effects, and even the reputation of the vaccine and the process of fighting crown disease in the future.
