Question Number: 135
PDR Number: SQ22-000156
Date Submitted: 24/02/2022
Department or Body: Department of Health

The Therapeutic Goods Administration (TGA) disagrees with the Senator’s assertions. The Pfizer post marketing surveillance data report does not indicate that its COVID-19 vaccine Comirnaty causes strokes, neurological events, myocardial infarction or cardiac failure.

The report was submitted to the United State’s Food and Drug Administration by Pfizer in April 2021 in relation to Comirnaty. The report provides an analysis of Pfizer’s safety database, which contains cases of adverse event reports collected by Pfizer up to 28 February 2021 from a range of sources, including a large number from spontaneous reporting systems. Reporting of an adverse event does not mean the event was caused by a drug or a vaccine. The analysis did not find any new safety concerns, and supports the favourable benefit-risk profile of the vaccine.

Event onset latency is a term used to describe the time from the administration of the drug or vaccine, in this case Comirnaty, to the onset of the adverse event. In the case of stroke, neurological events, and cardiovascular events, most reported events occurred within one to two days following vaccine administration, with some reported events occurring several weeks after the vaccine administration. This does not mean that these events were caused by the vaccine, nor does it indicate that there is a delay of treatment for patients with adverse events.

At present, stroke is not listed in the Product Information (PI) as a recognised side effect of Comirnaty. This is because there is not currently evidence for a link between Comirnaty and strokes. Therefore, it would not be appropriate for Deputy Secretary Skerritt to make the ‘apology’ called for as it would not be based on evidence.