National Health Commission: Reference Catalogue and Explanations for the Scope of Compensation for Adverse Reactions Following Immunization (2020 Edition)
Release time:
2021-08-24
This directory primarily provides a reference framework for the investigation, diagnosis, appraisal, and compensation of adverse reactions following immunization.
Reference Catalogue and Explanations for the Scope of Compensation for Adverse Reactions Following Immunization
(2020 Edition)
I. Reference Catalogue of the Scope of Compensation for Adverse Reactions Following Immunization
II. Relevant Notes
(1) Instructions for Using the Table of Contents.
This directory is primarily intended to provide a reference framework for the investigation, diagnosis, appraisal, and compensation of adverse reactions following immunization. When a vaccine recipient experiences a suspected adverse reaction following immunization, the investigation, diagnosis, or appraisal process must, in addition to referring to this directory, take into account relevant clinical and laboratory data to determine whether the reaction qualifies as an adverse reaction following immunization or whether such qualification cannot be ruled out. The mere fact that a reaction falls within the scope of this directory should not be used as the sole basis for determining whether the reaction constitutes an adverse reaction following immunization or whether it cannot be excluded.
Where, during or following the administration of a vaccine, the vaccinated person suffers death, severe disability, or damage to organs or tissues—such harm that is classified as an adverse reaction to immunization or cannot be ruled out—compensation shall be provided.
In practical work, when robust evidence is obtained that can establish, support, or rule out a causal relationship between a vaccine and a disease, or when the typical time window between vaccination and disease onset is found to have changed, such evidence should be taken into account in investigations, diagnoses, appraisals, and compensation related to adverse reactions following immunization.
(2) Explanation of the criteria for determining adverse reactions following immunization.
Case investigation, diagnosis, and assessment shall be conducted in a standardized manner. A reaction may be classified as an adverse event following immunization if it simultaneously meets the following criteria:
1. The clinical diagnosis of the disease is clear and meets the clinical diagnostic criteria;
2. Clearly rule out other etiologies: There must be definitive clinical or laboratory evidence supporting a causal relationship between the vaccine and the disease, or definitive clinical or laboratory evidence that other significant causative factors (such as infection, trauma, poisoning, etc.) have been ruled out. Detailed information on past medical history, onset of illness, clinical examination, and laboratory tests can help identify and explain whether other important etiologies are present.
3. Vaccine-related injuries that are currently recognized within the known scientific literature: diseases listed in this catalog for which a causal relationship between the disease and the vaccine has been established or is strongly supported.
4. The time interval between vaccination and the onset of the disease may be referenced against the common time ranges provided in this directory.
(3) Explanation of the criteria for determining whether an adverse reaction following immunization cannot be ruled out.
Case investigation, diagnosis, or assessment shall be conducted in a standardized manner. A case may be determined as not excluding an adverse reaction following immunization if it simultaneously meets the following criteria:
1. The clinical diagnosis of the disease is clear and meets the clinical diagnostic criteria.
2. Basic exclusion of other etiologies: There must be clinical or laboratory evidence that tends to support the hypothesis that the disease was caused by the vaccine, or there must be clinical or laboratory evidence that essentially rules out other important causative factors (such as infection, trauma, poisoning, etc.). In particular, for diseases in this catalog for which definitive causal association studies have not yet been conducted, a conclusion that an adverse reaction following immunization cannot be ruled out may be reached only after excluding evidence of other significant potential causes through review of past medical history, onset history, clinical examination, and laboratory tests.
3. Vaccine injuries that are currently known, or are reasonably suspected, to fall within the scope of this catalog: diseases associated with adverse reactions listed in this catalog;
4. The time interval between vaccination and the onset of the disease may be referenced against the common time ranges provided in this directory.
(4) Explanation of the criteria for determining vaccine-associated paralytic poliomyelitis or poliomyelitis caused by vaccine-derived poliovirus in contacts of individuals who have received oral live attenuated poliovirus vaccine.
Investigation and diagnosis may be conducted by a provincial-level expert panel for the investigation and diagnosis of adverse reactions following immunization. Where cases meet the diagnostic criteria for vaccine-associated paralytic poliomyelitis or vaccine-derived poliovirus–associated poliomyelitis as specified in the “Diagnostic Criteria for Poliomyelitis” (Health Industry Standard WS294-2016) for contacts of oral polio vaccine recipients, compensation shall be provided in accordance with the provisions applicable to vaccine-associated paralytic poliomyelitis in vaccine recipients.
(5) Explanation of Content Adjustments.
This catalog and its accompanying instructions shall be dynamically adjusted as the evidence chain is refined and in accordance with operational needs. The Chinese Center for Disease Control and Prevention has organized the development of the Guideline for the Reference Catalog of Compensation Coverage for Adverse Events Following Immunization (2020 Edition).
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