TGA publishes vaccine safety monitoring plan

Pharma News: The Therapeutic Goods Administration (TGA) has published a five-point plan detailing the enhanced measures it will put in place to ensure the timely identification and mitigation of safety issues during the roll out of COVID-19 vaccines.

The publication of the plan follows the recent provisional approvals of Pfizer/BioNTech and AstraZeneca/University of Oxford vaccines, and the start of a national vaccination strategy that is initially targeting around 700,000 people, including quarantine and border workers and the residents and staff at aged and disability care facilities.

The agency aims to “strengthen the existing vaccine vigilance system for early detection and investigation of suspected side effects,” thereby enabling it to manage emerging safety issues and maintain public confidence.

Specifically, TGA is putting into place an enhanced adverse event reporting process to ensure the timely collection and management of reports; forms will be particularised for each vaccine and will be sharable between its staff and regional officials.

The agency also seeks to enhance safety signal detection and investigation by ensuring it has the capacity to perform timely reviews of adverse event reports and the ability to collaborate in real time with AusVaxSafety, the national vaccine safety system. Upon identification of a safety concern, TGA will “use legislative provisions available to achieve effective and timely regulatory action” that may help to address or reduce the emerging risk.

TGA also will ensure information quickly reaches consumers, health professionals and sponsors and will proactively monitor media reports to proactively identify public concerns about vaccine safety.

To achieve those goals, TGA plans to collaborate with state and federal governments and experts in Australia on the consolidation of “timely information sharing, communication and collaboration with national stakeholders on COVID-19 vaccine safety,” as well as with officials and regulators overseas.

See details of TGA’s Monitoring Plan.