Senator RENNICK: Okay; that’s fine. When you review that data, can you please tell me how many people in the placebo trial were hospitalised, how many in the inoculation trial were hospitalised and how many died in the initial Pfizer trial?Dr Skerritt: Senator, we’ll put the data on deaths in the placebo and active arm as an answer to a question on notice.Senator RENNICK: I know the answer to that now; it’s actually zero and zero, because the initial Pfizer trial had no clinical outcomes in terms of hospitalisations and death and it had no-Dr Skerritt: Senator, I do not believe that is correct.Senator RENNICK: In the initial Pfizer trial, in the six-month data, there are different numbers, but-Dr Skerritt: Senator, I do not believe that you are correct-Senator RENNICK: Okay. We can move on.Dr Skerritt: I’m happy to, on notice. I do not believe that the Pfizer trial for the COVID-19 vaccine lacked data on hospitalisations. I do not believe that your assertion is correct.Senator RENNICK: Okay. I did not say it lacked data; I asked how many went to hospital. I’m asking you how many went to hospital and how many died in the inoculation group and the placebo group.Dr Skerritt: We will provide that information on notice.Senator RENNICK: Could you also provide subclinical outcomes regarding clotting and inflammation.Dr Skerritt: We’ll provide that additional information from the trial data, on notice.Senator RENNICK: Yes, on the initial trial data and not the six-month trial data.Dr Skerritt: Yes, on the initial. As long as-Senator RENNICK: Okay. Thanks, Chair.

Question Number: 99
PDR Number: SQ22-000015
Date Submitted: 24/02/2022
Department or Body: Department of Health

The statistics requested from the pivotal Pfizer trial used by provisional registration of the vaccine, C4591001, are presented below.

No Grade four local reactions or systemic events (i.e., a potentially life-threatening reaction requiring urgent intervention such as a visit to the emergency room or hospitalisation) were reported in the clinical trial.

A secondary end point of clinical trial C4591001 was to measure the efficacy of the Pfizer COVID-19 vaccine against severe COVID-19. Severe COVID-19 was defined as confirmed cases of COVID-19 with one of the following additional features: clinical signs at rest that are indicative of severe systemic illness, respiratory failure; evidence of shock, significant acute renal, hepatic, or neurologic dysfunction; admission to an intensive care unit; or death. This can be interpreted as meaning that individuals who developed severe COVID-19 would be hospitalised.

The initial trial results (see: www.nejm.org/doi/full/10.1056/nejmoa2034577) reported that ten participants developed severe COVID-19 at various stages after receiving the first dose of COVID-19 vaccine: one case was in the vaccinated group and nine in the placebo group. The six-month follow-up trial results (see: www.nejm.org/doi/full/10.1056/nejmoa2110345) reported 31 participants developed severe COVID-19 at various stages after receiving the first dose of COVID-19 vaccine: one case was in the vaccinated group and 30 in the placebo group.

No COVID-19-related deaths were observed. However, the initial trial results reported that six participants died before the data cut-off date of 14 November 2020. These deaths were assessed as not related to the study intervention.

• Placebo group: four deaths
o Two from unknown causes
o One participant suffered a hemorrhagic stroke
o One participant suffered a myocardial infarction

• Vaccinated group: two deaths
o One from arteriosclerosis
o One from cardiac arrest

The six-month follow-up trial results reported that 29 participants died during the blinded, placebo-controlled period. None of these deaths were considered to be related to the Pfizer COVID-19 vaccine.

• Placebo group: 14 deaths
• Vaccinated group: 15 deaths

In addition, five participants died during the open-label period, and none of these deaths were considered to be related to the Pfizer COVID-19 vaccine:

• Placebo group: two deaths
• Vaccinated group: three deaths

The study of vaccine safety at six months did not identify subclinical outcomes of clotting or inflammation.