The ICH E2D guideline defines a spontaneous report as “an unsolicited communication by a health-care professional or consumer to a manufacturer, regulatory authority or other organization that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme”. This definition applies to adverse event following immunization (AEFI) reports as well where a report involves one or more adverse events that follow the administration of one or more vaccines.
The primary purpose of spontaneous reporting is to identify safety signals after a product is marketed. While proof of product safety and efficacy are required for licensure, rare or very rare reactions may not be detectable until a product is used in a population setting.
Of further relevance to vaccines, as complex biological products, while every effort is made to ensure each lot of vaccine matches the lots used in the studies on which the vaccine product licensure was based, the potential for product variation that could result in a safety signal must always be considered.
For regulatory reporting the minimum data elements required include an identifiable reporter, an identifiable patient, an adverse event and a suspect product.
The primary reporter is the person who first reports an AEFI. In many settings the primary reporter submits a report to an intermediary such as local public health authorities or the vaccine manufacturer who are considered onward reporters in that they send the report on to the national regulatory authority. The onward reporters may seek to clarify or expand on the information before sending the report on.
From there, reports are sent to the next reporting subnational level(s), ending at the national-level unit and global institutions responsible for AEFI surveillance.
Given the purpose of spontaneous reporting it should be clear that the general definition of AEFI is most relevant to this context since as long as a causal relationship is at least a reasonable possibility, i.e. cannot be ruled out, the AEFI should be reported. In other words suspicion alone is sufficient for reporting and the primary reporter is not expected to assess causality which is implied when considering the cause-specific definitions.
Rapid detection and evaluation of safety signals is essential to ensure the continued safety of vaccines. Thus, provided there is suspicion it is preferable to submit a report on a timely basis rather than wait for all aspects of an investigation into the cause to be completed. This is particularly true for reports which meet the criteria to be considered serious reports.
The primary reporters should be encouraged to provide complete details about patient i.e, details about the event in question (including specific signs and symptoms) or relevant medical history help to determine whether it meets a case definition. Reasons for any suspicion that an AEFI may be related to the vaccine product, a vaccine quality defect, an immunization error or immunization anxiety can be included in an AEFI case report by the primary or any onward reporter. Similarly, details regarding concomitant medication or illness or prior conditions in the vaccine should be included in the primary or follow-up reports because they provide important information for considering whether an AEFI was coincidental or causally related to immunization. It should be noted that some jurisdictions consider lack of efficacy to be an adverse event and thus want vaccination failure to be reported as an AEFI.
Leave a Reply