Adverse Event Following Immunization (AEFI)

In Kingdom of Bahrain, there are several procedures in place for monitoring of vaccines. The national health regulatory authority is responsible for vaccine licensing and procedures related to their registrations based on data related to safety, immunogenicity, quality and efficacy. Vaccines are procured through pooled procurement with other GCC states and vaccine shipments are checked upon arrival to central vaccine store at ministry of health to ensure reliability, and compliance with international standards for vaccine shipment. Periodic visits are conducted to all health facilities providing vaccination services to ensure compliance with cold chain standards. Furthermore, training to build the capacity of healthcare providers on vaccine management is done to minimize the risk of programmatic errors and improve screening for vaccines contraindication. A hotline service was introduced to provide guidance and support to healthcare providers on vaccine related issues. Additionally, instructive monitoring field visits are conducted for vaccine management and data quality and accuracy assessment.

Moreover, a program was established by ministry of health on adverse events following immunization (AEFI) that includes reporting, investigation, monitoring, and evaluation of compliance with standard operating procedures. All suspected AEFI should be evaluated and managed by treating physicians and reported by concerned healthcare provider to Public Health Directorate in order to investigate the case.

Any reaction following administration of the vaccine and can be classified based on the following:

• Frequency of occurrence (common, rare)
• Extent (local, systemic)
• Severity of the event (mild resolved spontaneously, require hospitalization, resulted in consequence)
• Causality and preventability (intrinsic to vaccine, faulty production, faulty administration).

In addition based on causality the AEFI is classified to the following:

• Vaccine quality defect reaction
• Vaccine product related reactions (vaccine induced) such as erythema at injection site after vaccination with certain vaccines.
• Vaccine-potentiated related reactions: The event would have occurred anyway with or without vaccination, such as fever following vaccination might potentiate febrile seizure in a child with predisposition to febrile seizure with or without vaccination.
• Immunization error-related reaction such as errors in vaccine storage, preparation, handling, or administration.
• Immunization anxiety related reaction such as vasovagal fainting attack due to extreme fears from injections.
• Coincidental: The reported event was not caused by vaccination but happened by chance occurrence or due to underlying illness occurred at the same period.

Generally the observed reaction rate is compared with the expected rate based on published studies. Currently, most of reported adverse events following immunization in the kingdom are mild local reaction resolved without consequences.

Any suspected case of Adverse Event Following Immunization advice to seek medical care..

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