CD-JEV AEFI monitoring CD-JEV Japanese Encephalitis Vaccine Introduction Training Modules for Health Care Workers Module 6 CD-JEV AEFI monitoring
Learning objectives At the end of the module, the participant will be able to: Identify adverse events following immunization (AEFIs). Explain how to report AEFIs. Duration: 15 minutes
Key issues 1 2 What are the AEFIs of CD-JEV vaccine? How do I report an AEFI? 2 To the facilitator: Explain to the participants the key issues raised regarding AEFIs. What are the AEFIs of CD-JEV vaccine? How do I report an AEFI?
What is an AEFI? AEFI = Adverse event following immunization. Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. AEFIs can be categorized into: Reaction related to vaccine product. Reaction related to vaccine quality defect. Reaction related to immunization error. Reaction related to immunization anxiety. Coincidental event. Unknown. To the facilitator: Explain to the participants the definition of an AEFI and its different causes. Reaction related to vaccine product An AEFI that is caused or precipitated by a vaccine due to one or more of the inherent properties of the vaccine product. Example: Extensive limb swelling following DTP vaccination. Reaction related to vaccine quality defect An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects of the vaccine product including its administration device as provided by the manufacturer. Example: Failure by the manufacturer to completely inactivate a lot of inactivated polio (IPV). A live vaccine can lead to cases of paralytic polio. Reaction related to immunization error An AEFI that is caused by inappropriate vaccine handling, prescribing or administration and thus by its nature is preventable. Example: Transmission of infection by contaminated multidose vial. Reaction related to immunization anxiety An AEFI arising from anxiety about the immunization. Example: Vasovagal syncope is neurovascular reaction that leads to fainting in an adolescent during/following vaccination. Coincidental event An AEFI that is caused by something other than the vaccine product, immunization error or immunization anxiety. Example: A fever occurs at the time of the vaccination (temporal association). Two or more events that occur around the same time, but the preceding event may or may not be causally related to the later one. 4
What is the risk of AEFIs with CD-JEV vaccine? CD-JEV is “prequalified” by WHO, which means the vaccine has been assessed by the WHO and meets high safety standards for the target population. Local reactions at the injection site such as redness and swelling have been reported in 1% to 15% of vaccine recipients. Systemic reactions such as mild fever, irritability, nausea and dizziness have been very rarely reported; high fever was reported in 5% to 20% of recipients. Few allergic reactions have been reported with CD-JEV. If a child becomes severely ill or appears to have an allergic reaction in the days following the immunization, the parent should bring the child to a hospital or clinic as soon as possible. To the facilitator: Explain to the participants the risk of AEFI with CD-JEV JE vaccine. Emphasize that: To date, CD-JEV has not been linked to any deaths, serious neurologic illness/impairment, serious hypersensitivity reaction, or prolonged hospitalization. If a child becomes severely ill or appears to have an allergic reaction in the days following the immunization, the parent should bring the child to a hospital or clinic as soon as possible. 5
How to report an AEFI (1/2) Report the identified AEFI through existing AEFI reporting systems established by national immunization programmes. In addition to vaccine reactions, AEFIs can include programme errors or injection reactions, or reasons can be coincidental or unknown. Immediately report and refer for medical treatment if a child develops a condition such as fever higher than 38.5⁰C or a severe hypersensitivity reaction. To the facilitator: Explain to the participants how to report an AEFI. 6
How to report an AEFI (2/2) The AEFI report should be completed thoroughly and contain: Place of vaccination. Name of reporting officer. Patient name and details about vaccination. Patient information prior to immunization. Details of first examination of serious AEFI case. Details of vaccines provided at the site that are linked to AEFI on the corresponding day. Immunization practices where AEFI-related vaccine was used. Cold chain and transport details. What community investigation was done. To the facilitator: Explain to the participants the details of reporting an AEFI. 7
Key messages CD-JEV has been assessed by the WHO and meets high safety standards for the target population. In addition to vaccine reactions, AEFIs can include programme errors or injection reactions, or reasons can be coincidental or unknown. If a child becomes severely ill or appears to have an allergic reaction in the days following the immunization, the parent or caregiver should bring the child to a hospital or clinic as soon as possible. Report AEFIs through existing reporting systems established by the national immunization programme; make sure the report is filled out completely. To the facilitator: Explain to the participants that this is the main information to keep in mind. 8
End of module Thank you for your attention! Next is Module 7: CD-JEV vaccine communication with caregivers To the facilitator: This is the end of the module. You have been introduced to “CD-JEV AEFI monitoring.” The following module is titled “CD-JEV vaccine communication with caregivers.” Thank you for your attention!