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QUESTION ON NOTICE

Question:

21 November 2022

43. In the post marketing report on page 6 it says “Pfizer has also taken multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately 600 additional fulltime employees (FTEs). More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.” Surely if the vaccine was safe and effective Pfizer wouldn’t need to employ an additional 1,800 staff to deal with adverse events? Isn’t this in itself a concerning safety signal?

Answer:

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.

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