Source: The Paper
Since the first death case was announced on October 16, the cumulative number of deaths in South Korea after receiving the flu vaccine has reached 88, of which 73 are over 70 years old. On November 3, the South Korean Office of Disease Management released this set of data, saying that by conducting epidemiological investigations, basic investigations and autopsy studies on 83 of them, it is currently difficult to confirm the correlation between death and influenza vaccination. Therefore, it was decided not to consider stopping the original national influenza vaccination program.
This means that more than 7 million people will still receive the flu vaccine that has attracted public attention for free.
According to multiple Korean media reports, the plan began at the end of September this year, and proposed to receive free flu vaccines for 19 million people, mainly covering teenagers, pregnant women and the elderly. Surprisingly, although the idea is good, it hits walls one after another. The vaccine plan has successively fallen into negative public opinion such as "room temperature vaccine" that does not guarantee refrigerated transportation, white particles, and death after vaccination.
Although the number of deaths reported after receiving influenza vaccination has been increasing for half a month, South Korea has never stopped free vaccination in order to prevent the dangerous situation of both influenza and the new crown epidemic.
A vaccine person analyzed that most of the dead this time are elderly people. They had health diseases before vaccination and were dispersed by vaccine manufacturers. It has been confirmed that there is no quality problem, which is likely to be a coincidence event that has no causal relationship with the vaccine. Some experts also have different opinions, believing that it is not rigorous enough to draw "irrelevant" conclusions in a short period of time and should be treated with caution.
It is worth noting that a causal relationship assessment manual for the Immunization Adverse Events (AEFI) released by the World Health Organization in 2019 prompts that the causal relationship of individual cases is usually difficult to determine, so you can only try to grasp the degree of correlation, and causal relationship determination may change with the increase of information.
When evaluating the causal relationship of adverse reaction events after vaccination, WHO recommends the use of a unified algorithmic process to facilitate judgment and classification. Source: AEFI Causal Relationship Assessment Manual
The causal relationship of adverse reaction events after vaccination is first divided into whether sufficient information is obtained, such as sufficient information is obtained, and then subdivided.
What causal relationships may exist between adverse events that occur after vaccination and vaccines? In the case of difficulty in determining, how does the current global evaluation plan work? The answers to these questions are closely related to how to view and respond to adverse vaccination events, and also help to view South Korea's attitude towards the flu vaccine storm.
South Korea: The causal relationship of deaths is uncertain, more like a coincidence
Public reports show that on September 21, South Korea's free influenza vaccine program for children under the age of 18, pregnant women and elderly people over 62 were urgently stopped because some companies did not refrigerate the vaccine as required during transportation. The South Korean Disease Management Department urged the recent vaccination to conduct thorough monitoring and recalled the batch of "room-temperature vaccines" totaling 480,000, and the free vaccination will not resume until October 13.
According to China News Service, the influenza vaccine adopted by the free vaccination program in South Korea is supplied by five pharmaceutical companies, namely the local GC Pharmaceutical Company, SK Biotechnology, Yiyang Pharmaceutical Company, France's Sanofi Group and the UK's GlaxoSmithKline Company. Dealers include South Korea's LG Chemical Company and Baoning Pharmaceutical Company.
Relevant South Korean authorities responded that the "room temperature vaccine" will only cause the vaccine to fail and will not produce toxic and harmful substances.
Coincidentally, on October 6, another flu vaccine in South Korea was found to have "contained white particles". Although the relevant pharmaceutical companies voluntarily recalled 615,000 vaccines involved, it still cannot eliminate the public's concerns about the safety of influenza vaccines. Until October 27, the South Korean Food and Drug Safety Department issued the investigation results saying that "white particulate matter" is a protein, and there are no problems with the safety and effectiveness of related vaccines. In order to eliminate social concerns, all vaccines involved have been invalidated.
In other words, whether it is a "room temperature vaccine" or a "white particulate matter", South Korea's official has confirmed that it will not cause serious adverse effects on the human body, and at most it will only lose its original protective effect.So what is the cause of the death?
Public information shows that the first death occurred on October 16, and a 17-year-old boy died two days after receiving the flu vaccine. The reason is still unknown.
In the next week, the South Korean Department of Disease Management soon received more than 30 deaths after receiving influenza vaccine, and more than 80% of the dead were elderly people over 60 years old. On October 21, the South Korean Department of Disease Management held an emergency press conference, saying that an investigation into six of the cases found that no matter the type of influenza vaccination, the vaccination agency or personal underlying diseases, six people have no common ground, and the remaining hundreds of thousands of people in South Korea have also received the relevant vaccine, but they have not experienced serious abnormal symptoms.
According to the South Korean Department of Disease Management, on October 31, the number of deaths rose to 83, including 71 over the age of 70. There are 50 deaths 48 hours or more after receiving the influenza vaccine, and 13 deaths less than 24 hours after receiving the influenza vaccine. As of November 3, the number of deaths has reached 88, of which 73 are over 70 years old.
At this time, South Korea has conducted epidemiological investigations, basic investigations and autopsy results on 83 deaths. The results show that most cases originally had underlying diseases and it is difficult to confirm the association between death and vaccination.
Judging from the statements of the Korean health department, the possibility of being related to vaccine products and vaccination has been basically ruled out, and it is tending to characterize it as a coupling event that is not related to vaccines.
According to the definition of the World Health Organization, if death caused by potential or emerging diseases, or diseases caused by other factors outside the vaccine, is a coincidence event; if the causal relationship cannot be judged due to insufficient evidence, it should be classified as an uncertain event; only adverse events caused by quality defects, or vaccination errors and anxiety are confirmed to be related to the vaccine.
Another factor that is concerned is background mortality. According to the calculations of vaccine professional Tao Lina, the proportion of natural deaths of the elderly in the past in South Korea is much higher than the reported mortality rate this time, which means that even if the flu vaccine is not vaccinated, the same number of deaths in the elderly are within the normal range.
The Korean Department of Disease Management once pointed out that the reason why the number of deaths reported this year "spicks" is because the "room temperature vaccine" and "white particulate matter" incidents have attracted widespread social attention, and the number of cases reported has also increased accordingly.
is based on the judgment of tendency coupling. South Korea has not stopped vaccination from beginning to end. The South Korean Prime Minister took the lead in getting influenza vaccinated within one week of the accident. The South Korean president even publicly called on the public to get influenza vaccinated as soon as possible, thereby avoiding the greater risk of the new crown and influenza epidemic.
New information may change causal relationships, and there are precedents in the past
Although the South Korean government is full of confidence in influenza vaccines, the Korean people have quite complaints about its safety. There are reports that there are more and more voices in South Korea asking for postponement of vaccination, and some nursing homes have decided to collectively give up the vaccination of influenza vaccines. At present, nearly 13 million people in South Korea have completed free vaccination, and there are still more than 7 million people away from the target of 19 million.
Concerns about influenza vaccines have also reduced public trust in the coronavirus vaccine. According to the New York Times, a survey of 2,500 people conducted in the South Korean populous province of Gyeonggi-do in early October showed that 62% of respondents believed that they would not choose to be vaccinated until the coronavirus vaccine proved completely safe.
Because it is also using the flu vaccine produced in South Korea, the "snatching wave" in Taiwan is also falling. CCTV News said that as of October 30, Taiwan has reported a total of 7 deaths after receiving influenza vaccine, and all adverse reaction reports have set records since the announcement. However, Taiwan said that due to the adverse reactions not concentrated on a certain vaccine, four of which were initially judged to have died of chronic diseases, the suspension of vaccination will not be considered.
The difference is that out of caution, in order to avoid similar incidents, Singapore and Malaysia suspended the use of two vaccines produced in South Korea on October 25 and 29 (SK Biotech's SKYCellflu Quadrivalent and Sanofi's VaxigripTetra). However, as South Korea's investigation progresses, the two countries have recently announced the resumption of the use of two vaccines.
In response to this, Tao Lina publicly wrote an article to support the South Korean government's handling. He believes that the vaccine manufacturers involved are highly scattered, most of them are the elderly, and most of them suffer from other diseases before vaccination. It is estimated that except for the death caused by anaphylactic shock, it must be a coincidence.
A vaccine expert who did not want to be named expressed concerns to The Paper. He analyzed that the government and enterprises tend to shirke responsibility, so he is very willing to accept the conclusion of coupling, but he believes that this is not a scientific attitude: "The US FDA also admits that human understanding is far from enough. If there is no serious research and sufficient evidence to declare coupling, it is definitely not comprehensive enough."
According to him, the general incidence of serious adverse reactions to influenza vaccination is less than 1/1 million. Even if it is the "swine flu vaccine incident" in the United States in 1978, the mortality rate does not exceed 3/1 million, while the mortality rate this time exceeds 6/1 million. He believes that South Korea should be more cautious influenza vaccinated. At the same time, relevant R&D companies should reflect more on how to ensure the safety of vaccines and how to better preserve vaccines.
In terms of how to judge and deal with adverse events, the World Health Organization released the latest revised causal assessment manual for adverse events (AEFI) in 2019. The evaluation manual states that the relationship between the incident and the vaccine product and the vaccination process should be carefully investigated item by item, whether the incident occurred within the window period, whether there is strong evidence that does not support the causal relationship, whether there is evidence for other reasons, and other factors that may affect the qualitative nature.
manual emphasizes that whether for the same case or similar cases, the conclusions of causality may change when more information can be obtained.
For example, narcolepsy occurs after influenza A H1N1 flu vaccine, which can be classified as post-vaccination adverse events that may be related to vaccine products; and before 2010, when scientific evidence was not determined based on scientific evidence, the same cases would be classified as a coupling or uncertain case.
Similarly, the manual states that for coupled or uncertain cases (especially uncertain cases), if events reported from one or more sources are similar, the recorded cases may indicate a new potential causal relationship between the vaccine and an event or a series of related events, or a new manifestation of known causal relationships.
In short, if more information is available, cases may be reclassified and classified into more explicit categories. WHO recommends that guidance may be sought from the Global Advisory Committee on Vaccine Safety (GACVS) if needed, especially when adverse events are likely to seriously affect immunization programs.
The significance of this Korean influenza vaccine storm should not be limited to the incident itself, but also a test of the government's scientific understanding. It is a valuable opportunity for the public to understand vaccines rationally, and it is also something that all immunizations are worth reflecting on.
[Extended Reading]
The official website of the National Medical Products Administration shows that there are currently no influenza vaccines produced in South Korea and are not available for use in mainland my country.
According to data from the China Food and Drug Inspection Institute, the influenza vaccines approved and issued in mainland China in 2020-2021 include trivalent inactivated vaccine , trivalent live attenuated vaccine and tetravalent inactivated vaccine. Manufacturers include Hualan Biology, Shenzhen Sanofi Pasteur, Changchun Biology, Beijing Kexing , Jiangsu Jindik Biology, Dalian Yalifeng Biology, Zhongyi Anke Biology, Changchun Baike Biology, Wuhan Institute of Biological Products, etc. Types and specifications of influenza vaccines issued domestically in
020-2021. Source: China Food and Drug Inspection Institute
There are no media reports on related adverse reactions.
Chinese Center for Disease Control and Prevention introduced that inactivated vaccines through intramuscular injection is safe, and there is no difference in safety between tetravalent and trivalent inactivated influenza vaccines. Common side effects are mainly manifested as local reactions (blush, swelling, nodules, pain, burning sensation, etc. at the vaccination site) and systemic reactions (fever, headache, dizziness, drowsiness, fatigue, , myalgia, general discomfort, nausea, vomiting, abdominal pain, diarrhea, etc.).It is usually mild and disappears on its own within a few days, with very few severe reactions.
As for the live attenuated vaccine, since it has not been used in the population on a large scale, no adverse reaction events have been reported. The newly launched live attenuated vaccine for freeze-dried nasal spray influenza in my country this year, and the results of its phase III clinical trials indicate that fever, runny nose/nasal congestion are very common adverse reactions (the probability of occurrence is ≥10%), sore throat, headache, fatigue or drowsiness, vomiting, decreased appetite, cough, upper respiratory tract infection, muscle pain, nausea, and irritability are common adverse reactions (1%≤ probability of occurrence is <10%),>
Experts remind that the global COVID-19 epidemic will continue this year, and the epidemic situation of the new crown epidemic and respiratory infectious diseases such as influenza may occur this winter and next spring. Influenza vaccination is the most effective way to prevent influenza, which can reduce the harm caused by influenza-related diseases and the utilization of medical resources.
The annual seasonal epidemic of influenza can cause 3 million to 5 million severe cases and 290,000 to 650,000 respiratory disease-related deaths worldwide. Pregnant women, infants, the elderly and patients with chronic underlying diseases are at high risk.
