Question Number: 166
PDR Number: SQ22-000535
Date Submitted: 21/11/2022
Department or Body: Department of Health
It is not a concerning safety signal when a sponsor employs additional staff to ensure they meet their regulatory obligations. Globally there has been an unprecedented number of doses of the product administered in a short period, and extensive efforts to promote adverse event reporting coupled with the intense public interest in the safety of the vaccines, it is appropriate for sponsors to recruit additional staff to monitor vaccine safety. Reassuringly, the majority of adverse event reports for COVID-19 vaccines have been for common, expected and frequently mild reactions. Sponsors are required to review every adverse event report that they receive to determine if it is a serious adverse reaction. In Australia, serious adverse reaction reports must be submitted to the Therapeutic Goods Administration (TGA) within 15 calendar days of the sponsor receiving the minimum information for a valid report. Globally, other regulators have similar requirements.
