In the Freedom of Information request 3604 the TGA did not examine any documents relating to the composition of the final protein product produced following the injection of the Pfizer vaccine into humans. How can the TGA guarantee the safety of the Pfizer vaccine if no quality assurance has been performed around the composition of the protein that has been programmed to be mass produced by the body on an indeterminate basis?

Question Number: 187
PDR Number: SQ22-000202
Date Submitted: 24/02/2022
Department or Body: Department of Health

The safety of a vaccine cannot be assessed by the composition of the protein alone. Safety must be assessed in human clinical trials. The safety of the Pfizer COVID-19 vaccine was assessed through the actual use of the vaccine, first in animal trials and then in human clinical trials, which included over 40,000 participants (who were randomly allocated to the vaccinated group or the placebo group). Specific information about the trials carried out for the Pfizer COVID-19 vaccine can be found in the Australian Public Assessment Report (AusPAR), which also provides information about the evaluation of the vaccines and the considerations that led the Therapeutic Goods Administration (TGA) to approve the application. The AusPAR for the Pfizer COVID-19 vaccine is available at: www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna210125.pdf. It should be noted that it has been found that the vaccine induces the production of an immune response specific for the SARS-Cov-2 spike protein, indicating that the correct protein has been produced.

The TGA has robust procedures in place to detect and investigate signals for possible safety concerns with COVID-19 vaccines. If a safety concern is detected, rapid action will be taken to address the safety issue and promptly provide information to the public.

Additionally, to assure the quality of the vaccine product, TGA undertakes laboratory testing on every batch of the COMIRNATY vaccine, as part of the batch release assessment process. RNA integrity and identity is also assessed, which involves quantifying the amount of RNA ‘strands’ that are of correct length and sequence to be made into spike protein. A minimum amount of full length RNA must be present in each batch to pass this test. Additionally, the amount of fragment forms of RNA must be below a set specification. The specification limits set for these tests have been established as safe during the clinical development of the vaccine. The TGA Laboratories has also incubated the vaccine with cells in culture to ensure the correct protein is produced by the cells