Question Number: 278
PDR Number: SQ22-000649
Date Submitted: 21/11/2022
Department or Body: Department of Health
The Therapeutic Goods Administration (TGA) has provisionally approved booster doses of the Pfizer COVID-19 vaccine, COMIRNATY, in individuals aged five years and older. The safety and efficacy of this booster dose was demonstrated in clinical study C4591001, in which individuals who had previously completed their two-dose series were given a third shot. So, it is incorrect there were no adequate trial studies of three shots. This information is provided in the Australian Public Assessment Reports (AusPARs) for COMIRNATY. AusPARs are available on the TGAs website at: www.tga.gov.au/covid-19- vaccines. In addition, there are several dozen published studies in the top-tier clinical literature on real world safety and effectiveness of a booster doses, in range of different populations.
