Question Number: 260
PDR Number: SQ22-000631
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 274 In the six-month update of safety data provided by Pfizer, the number of participants reporting at least one occurrence of each listed event during the blinded, placebo-controlled follow-up period is listed below. Notably, of the 44,000 participants, only a very small number of participants were reported to have suffered strokes, paralysis, and heart attacks. The total number of reported events for an adverse event category may be different to the total number of participants experiencing events due to multiple terms being chosen to characterise the same incident in a single individual and/or the same individual may experience multiple incidents over different times.

In relation to ‘strokes’ (i.e. categories ‘Stroke, hemorrhagic’ and ‘Stroke, ischaemic’ combined) there were:
• 12 events reported among 12 individual participants who received COMIRNATY:
o nine individuals were > 55 years of age, and
o three individuals were 16-55 years of age.

• 11 events reported among 10 individual participants who received placebo:
o six individuals were > 55 years of age o two individuals were 16-55 years of age, and
o ages were not immediately available for the other two participants.

In relation to ‘Bell’s palsy’ (i.e. preferred terms ‘Facial paralysis’ and ‘Facial paresis’ combined) there were:
• four events reported among 4 individual participants who received COMIRNATY:
o two individuals were > 55 years of age, and o two individuals were 16-55 years of age.

• There were two events reported among two individual participants who received placebo:
o both of those individuals were aged > 55 years of age.

In relation to ‘heart attacks’ (i.e. category ‘Acute myocardial infarction’) there were:
• 11 events reported among 11 individual participants who received COMIRNATY:
o eight individuals were > 55 years of age, and
o three individuals were 16-55 years of age.

• There were 17 events reported among 15 individual participants who received placebo:
o nine individuals were > 55 years of age, and
o six individuals were 16-55 years of age.

There was no suggestion from the clinical trial results that these events occurred any more frequently than would have otherwise occurred in the background population. It is highly unlikely that the COVID-19 vaccine is responsible for adverse events such as stroke, paralysis and heart attacks.

Question 275
• Information on follow up data is provided in response to Q273 in SQ22-000630. There were no cases of myocarditis in the vaccine group, but there was one case in placebo group. No cases of pericarditis were reported at one month post dose two.
• For current rates of myocarditis and pericarditis reported after vaccination in Australia, please see: www.tga.gov.au/news/covid-19-vaccine-safety-reports.