Netizens say they have “small red buns” all over their bodies after receiving the new crown vaccine: How is it considered an adverse reaction? Who is responsible for the risk?

With the further promotion of the new crown vaccination, people’s concerns about vaccines are beginning to focus on more practical and concrete issues. Just recently, a netizen shared his and his Family‘s vaccination experience on Weibo.

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In this user’s account, she and her husband received their first dose of New Crown vaccine on February 17, and after a half-hour stay, they did not experience any symptoms of discomfort. However, from February 23, her husband began to develop “small red bumps” on his body, with a high fever of 38.5 degrees or more, and “painful and itchy, unable to sleep.

He went to the hospital for treatment, but the situation improved. It’s hard to say if this was a reaction to the vaccine, but our whole family now thinks it was the vaccine.

Abnormalities after vaccination ≠ adverse vaccine reactions

In fact, various conditions that occur after vaccination may not always be caused by vaccination and require further differential diagnosis.

Adverse Events Following Immunization (AEFI) is a concept commonly used in China that encompasses all reactions or events that occur after vaccination and are suspected to be related to vaccination.

In other words, AEFI may or may not be related to vaccination.

Depending on the cause, AFEIs are often classified into 5 categories: adverse reactions (including general and abnormal reactions), vaccine quality incidents, vaccination incidents, coincidental reactions, and psychogenic reactions.

Among them, the one most related to the vaccine itself and the most concerned is the adverse reaction.

If a vaccine is of acceptable quality, and the vaccination process and the vaccination institution are standardized and safe (i.e., vaccine quality accidents and vaccination accidents are excluded), but the vaccinated person still has a condition unrelated to the purpose of vaccination (disease prevention), this is an adverse reaction.

Adverse reactions are divided into general reactions and abnormal reactions.

General reactions usually refer to the more common symptoms such as fever, local redness, swelling, pain, weakness, loss of appetite, etc., and are relatively mild. According to the data released by the CDC, general reactions often account for more than 90% of all AEFIs.

Abnormal reactions, on the other hand, usually refer to more serious tissue and organ and functional damage, such as anaphylaxis, and may even lead to death. The probability of an abnormal reaction is generally in the range of tens to millions.

“The adverse reactions we have observed in Chinese vaccines are not exactly the same as those abroad. Jiao Yahui, the ombudsman of the National health Commission, had said in a question from reporters that no more serious abnormal reactions have been monitored in the domestic New Crown vaccine.

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Jiao Yahui, Ombudsman of the National Health and Welfare Commission

Source: Screenshot of news video

In addition to adverse reactions, coincidental and psychogenic reactions are also issues of concern.

“A coincidental reaction is when the vaccine recipient happens to be in the incubation period or pre-onset of another disease at the Time of vaccination, and at the time of vaccination, coincidentally, the disease also develops at the same time. Jiao Yahui said that the coincidental reaction has nothing to do with the vaccination process or the quality of the vaccine, so it is not an adverse reaction, but simply a “coincidence”.

Psychogenic reactions, on the other hand, are individual or group reactions that occur because of the psychological factors of the vaccinated person. Not only vaccination, but also any injection or even treatment can produce a psychogenic reaction. It often occurs in schools, kindergartens, and other places where children gather, and symptoms such as headache, dizziness, malaise, and nausea are common, but clinical examination is usually free of positive signs and organic lesions. Psychogenic reactions are also not considered as adverse reactions to vaccines.

Abnormalities need to be reported in a timely manner

A number of measures have been taken to deal with any abnormalities that may occur after vaccine conjugation.

First, the new crown vaccination sites need to be equipped not only for vaccination, but also for medical treatment, so that common adverse reactions can be quickly identified and disposed of.

Second, experienced emergency medical emergency personnel are sent from hospitals above the second level in each region to provide on-site coverage at the vaccination sites. In the event of a serious abnormal reaction, hospitals have also opened green channels.

According to past experience, adverse reactions tend to occur within 30 minutes after vaccination. Jiao Yahui said that at present, vaccinees are required to stay at the vaccination site for 30 minutes and go Home only if there are no problems.

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Wang Huaqing, chief expert on immunization planning at the Chinese CDC

Source: Screenshot from news video

If a vaccinated person has a suspected adverse reaction, it needs to be reported to the responsible unit/person in a timely manner.

Hospitals, vaccination sites, CDC agencies, adverse drug reaction monitoring agencies, and vaccine manufacturers are all responsible reporting units, and the staff of these units, too, are all responsible reporters. After the vaccinees report their vaccination time, symptoms and other information, the relevant monitoring and investigation procedures will be initiated.

Wang Huaqing, chief expert in immunization planning at the CDC, said that since 2005, the CDC has established monitoring systems for abnormal vaccine reactions, and these monitoring systems will follow up on reporting times, data, investigations and diagnoses in a timely manner. “If there are some important events, we will conduct timely analysis to assess some risks that may occur during vaccination.

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CDC Adverse Reaction Monitoring System

Source: Screenshot of news video

According to the Measures for Identification of Abnormal Reactions to Vaccination promulgated by the Ministry of Health, in addition to the investigation and diagnosis by the regional health administrative departments, the investigation procedures by municipal or provincial expert groups will be initiated in the event of one of the following three situations.

  1. death or serious disability of the vaccinated person;
  2. Suspected abnormal reactions to vaccination in groups;
  3. suspected abnormal reactions to vaccination that have a significant impact on society.

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Screenshot of the official government website

An expert group composed of experts in clinical, epidemiological, medical testing, pharmacological, forensic and other related disciplines will conduct a detailed investigation of the vaccination and the diagnosis and treatment, and finally determine whether it is an abnormal reaction to vaccination, and classify the degree of damage with reference to the “Medical Accident Classification Standards (for Trial Implementation)” issued by the Ministry of Health in 2002.

One-time compensation for serious adverse reactions

So, if a serious abnormality occurs after receiving the new crown vaccine, will it be compensated?

First, we need to clarify who is responsible.

If there is a problem with the quality of the vaccine itself or the operation of the vaccination agency, then the responsible party obviously lies with the manufacturer and the vaccination agency, and the vaccinator can resort to the law to defend his or her rights.

If there is no problem with the quality of the vaccine and the vaccination process is regular, then according to the Law of the People’s Republic of China on Vaccine Administration, the CDC needs to convene the AEFI Diagnostic Group experts to make a collective diagnosis to determine whether the abnormal reaction is related to this vaccination. If the abnormal reaction is indeed caused by this vaccination, then a one-time compensation should be given.

Secondly, we have to determine who will pay for the compensation if the vaccination is an immunization program vaccine (free vaccine) or a non-immunization program vaccine (self-pay vaccine).

Immunization program vaccines are vaccines provided by the state for free and citizens are obliged to receive them, such as BCG, polio vaccine, hepatitis B vaccine and so on. Non-immunization vaccines are other vaccines that citizens pay for and receive voluntarily, such as rabies vaccine, EV71 hand, foot and mouth disease, HPV vaccine, etc.

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Influenza vaccine is a class II vaccine

Image source: Tuworm Creative

If an abnormal reaction occurs after receiving a free vaccine, the compensation will come from the financial department of the people’s government of the province, autonomous region or municipality directly under the central government for vaccination work; if an abnormal reaction occurs after receiving a self-financed vaccine, the compensation will be borne by the vaccine manufacturer.

The specific how to compensate and how much to compensate are set by the people’s governments of provinces, autonomous regions and municipalities directly under the central government individually.

In general, the amount of compensation for abnormal reactions to vaccination includes basic expenses such as “medical expenses”, “lost work expenses” and “nursing expenses”. Guangdong Province added “disability Appraisal fee” and “transportation fee” to this amount, and Henan Province included “meal and accommodation allowance”, but Hebei, Zhejiang, Sichuan and Heilongjiang clearly stated that only basic expenses would be paid.

In addition, the amount of compensation in each provincial area is also related to the local economic situation. Most regions take the per capita disposable income of urban residents in the previous year as the base and set the corresponding compensation coefficient for the amount calculation, so the actual compensation amount may differ somewhat from place to place even when facing the same or similar situation.