Chinanews.com, May 28. The National Health Commission's website released on the 28th "Questions and Answers on Popularization of Knowledge about Adverse Reactions of New Coronavirus Vaccine Vaccination".

1. What is a suspected abnormal response to vaccination?

What situations are included?

  Suspected vaccination abnormal reaction (AdverseEventFollowingImmunization, AEFI) refers to a reaction or event suspected to be related to vaccination that occurs after an individual's vaccination.

  According to the causes of occurrence, AEFI can be divided into five categories, including adverse reactions, vaccine quality accidents, vaccination accidents, coincidences, and psychogenic reactions.

On May 27, citizens were vaccinated at the Community Health Service Center of Shipai Street, Tianhe District, Guangzhou City.

Photo by China News Agency reporter Chen Chuhong

2. What is a vaccine adverse reaction?

  Vaccine adverse reactions refer to reactions that are caused by the characteristics of the vaccine itself, are related to individual differences in the recipient, and have nothing to do with the purpose of vaccination or accidents, including general reactions and abnormal reactions. General reactions mainly refer to the inherent characteristics of the vaccine itself. The transient reaction caused, such as fever, local redness and swelling, induration and other symptoms.

Abnormal reactions mainly refer to adverse reactions that cause damage to the tissues, organs or functions of the recipient, which are rare, such as acute severe allergic reactions.

3. Why may a few people have adverse reactions after vaccination?

  After vaccination, while inducing the human immune system to produce protection against specific diseases, due to the biological characteristics of the vaccine itself and the differences between individual recipients, a small number of recipients may have adverse reactions after vaccination .

4. What does the abnormal response of vaccination specifically refer to?

  Abnormal response to preventive vaccination refers to an adverse reaction in which qualified vaccines cause damage to the tissues, organs, and functions of the recipient during or after the implementation of standardized vaccination, and no related parties are at fault.

It is particularly emphasized that there are three elements here: one is the consequence of damage; the other is that no party is at fault; the third is that there is a causal relationship between the result of the damage and vaccination.

5. What measures do individuals usually need to take after an abnormal reaction?

  If it is suspected to be an abnormal reaction after vaccination, it is necessary to go to the hospital for diagnosis and treatment in time, and consult and report to the vaccination clinic, medical institution or disease control institution.

For those requiring investigation, diagnosis, or identification, the recipient shall provide relevant materials such as past medical history, medical records and other medical records as required, and cooperate with follow-up related work.

6. What circumstances are not an abnormal response to vaccination?

  (1) General reactions after vaccination caused by the characteristics of the vaccine itself;

  (2) Damage to the recipient caused by the quality of the vaccine;

  (3) Damage to the recipient caused by the inoculation unit's violation of preventive vaccination work norms, immunization procedures, guidelines for the use of vaccines, and vaccination plans;

  (4) The recipient was in the incubation period or prodromal period of a certain disease at the time of vaccination, and the disease happened incidentally after vaccination;

  (5) The recipient has the vaccination contraindications stipulated in the vaccine manual, and the recipient or his guardian did not truthfully provide the recipient’s health status and vaccination contraindications before vaccination, and the recipient’s original disease has acute recurrence or condition after vaccination Aggravate

  (6) Individual or group psychogenic reactions due to psychological factors.

7. How is the monitoring of adverse reactions carried out in my country?

  The specific methods of adverse reaction monitoring in my country include clarifying the responsible reporting unit, responsible reporter, the content of the report, and the time limit of the report, and stipulating the circumstances under which the investigation needs to be initiated.

Among them, the diagnosis of abnormal reactions needs to be completed by the investigation and diagnosis expert group, and the identification needs to be completed by the provincial and municipal medical associations.

The monitoring work is realized through the monitoring information system, and the disease control agency and the adverse drug reaction monitoring agency realize information sharing.

Disease control agencies and adverse drug reaction monitoring agencies at all levels will also analyze and evaluate the monitored information on a regular basis.

If a major event is encountered, timely analysis and evaluation will be carried out.

8. What is the monitoring level of adverse reactions to vaccination in my country?

  The monitoring of adverse reactions of vaccination in my country started in 2005.

With the development and deepening of work, the level of vaccine adverse reaction monitoring has been greatly improved.

In 2011 and 2014, respectively, the World Health Organization (WHO) evaluated the adverse reaction monitoring function in my country's national vaccine regulatory system, and various monitoring indicators met or exceeded the WHO evaluation standards.

9. What is psychogenic response?

  Psychogenic reaction refers to the reaction that occurs due to the psychological factors of the recipient after vaccination, which is mainly caused by psychological pressure and anxiety during vaccination, without organic damage, and has nothing to do with the characteristics of the vaccine itself.

Some are "fainting"-like manifestations, and some are "hysteria"-like manifestations.

Group psychogenic reactions can occur during group vaccination activities.

10. What is the accidental reaction?

  Coupling disease (coupling reaction) means that during the vaccination process, the recipient happens to be in the incubation period or the early stage of the onset of a disease, and the disease occurs coincidentally after vaccination.

Therefore, the coupling disease (coupling reaction) is not caused by vaccination, has nothing to do with the vaccine, nor is it an adverse reaction after vaccination.

Sometimes it is not possible to make a judgment immediately after vaccination, and it needs to be verified or investigated by the disease control agency after the report.

11. What are the main adverse reactions of new coronavirus vaccination?

  Judging from the results of early clinical trials of the new coronavirus vaccine, the information collected during emergency use and large-scale population use after conditional marketing, my country's new coronavirus vaccine has good safety.

  The general reactions in the adverse reactions of the new coronavirus vaccine are mainly local reactions such as redness, swelling, induration, and pain at the vaccination site, and systemic reactions such as fever, fatigue, and headache. They are transient and mild body reactions that usually do not require treatment.

Judging from the results of the preliminary clinical trials of the new coronavirus vaccine, the information collected during the emergency use period and the large-scale population use after the conditional listing, the occurrence of common adverse reactions of the new coronavirus vaccine in my country is basically similar to that of other vaccines that have been widely used. Most of them are general reactions.

  The abnormal reaction in the adverse reaction of the new coronavirus vaccine mainly refers to the related reaction that causes the organ or function damage of the recipient. It is often manifested as an acute severe allergic reaction, etc., which rarely occurs and requires timely medical treatment.

12. Who will report the adverse reactions of the new coronavirus vaccine?

  If the recipient suspects that the uncomfortable symptoms may be related to the new coronavirus vaccination, they can report to the vaccination unit, or to the county-level disease control agency or the adverse drug reaction monitoring agency where the vaccination unit is located.

If the public cannot determine whether the symptoms are related to vaccination, they can consult the vaccination unit.

  Vaccination units, medical institutions, disease control institutions, adverse drug reaction monitoring institutions, and vaccine manufacturers are responsible for reporting adverse reactions to the new coronavirus vaccination.

Responsible reporting units receiving medical staff and staff engaged in vaccine adverse reaction monitoring are responsible reporters. After receiving a consultation or receiving a report of suspected vaccination abnormal reaction, those who meet the requirements of the monitoring and disposal plan shall be reported through the monitoring information system .