The AU-3S team has developed and launched a vaccine-specific reporting form for the Med Safety App based on the 25 WHO core variables for adverse event following immunisation (AEFI) reporting. This form can be used to report an AEFI for any vaccine that a country has approved for use. The form was designed to replace the use of paper forms with the aim of supporting countries to collect AEFI reports from vaccines more swiftly and efficiently. There are three major benefits, amongst others, that the form provides:

• Enables real-time visibility of all AEFIs being reported to both the national immunisation programme and the regulatory authority (EPIs and NRAs) – more swiftly identifying cases requiring follow-up to gather more information and/or obtain an update from the reporter.

• Enforces the use of drop-down lists or other data validation criteria when capturing information such as drug names or drug reactions, instead of capturing non-standardised free text. This improves data quality and ease of downstream safety data analysis.

• Allows a case to be updated, by the reporter, with additional information such as an outcome resolution or with further information on areas such as medical history or diagnosis test results.