Question Number: 164
PDR Number: SQ22-000155
Date Submitted: 24/02/2022
Department or Body: Department of Health
Question 169
As part of the provisional approval process, the Therapeutic Goods Administration (TGA) requires that a comprehensive Product Information (PI) document and Consumer Medicine Information (CMI) leaflet be made publicly available for healthcare professionals and consumers. Both documents contain a full list of the ingredients found in each of the COVID-19 vaccines, including the Pfizer and AstraZeneca COVID-19 vaccines. The PI and CMI documents are available on the TGA’s website at: www.tga.gov.au/covid-19-vaccines.
In the PI the active ingredients are listed under section two ‘Qualitative and Quantitative composition’ and excipient (non-active) ingredients under section 6.1 ‘List of Excipients’. In the CMI the ingredients are listed under section seven called ‘Product Details’.
AstraZeneca
Active ingredient:
• One dose (0.5 mL) contains 5×1010 viral particles (vp) of ChAdOx1-S [corresponding to not less than 2.5 × 108 infectious units (Inf.U)]
Excipient ingredients:
• histidine
• histidine hydrochloride monohydrate
• sodium chloride
• magnesium chloride hexahydrate
• disodium edetate
• sucrose
• ethanol absolute
• polysorbate 80
• water for injections.
Pfizer
Active ingredient for ages 12 years and above
• One dose (0.3 mL) contains 30 micrograms of COVID-mRNA vaccine (embedded in lipid nanoparticles)
Active ingredient for ages 5-11 years
• One dose (0.2 mL) contains 10 micrograms of COVID-mRNA vaccine (embedded in lipid nanoparticles)
Excipient ingredients (note: the two presentations are considered to be interchangeable)
Tris/Sucrose presentation
• ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
• 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
• distearoylphosphatidylcholine (DSPC)
• cholesterol
• trometamol/ trometamol hydrochloride
• sucrose
• water for injections
PBS/Sucrose presentation
• ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
• 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
• Distearoylphosphatidylcholine (DSPC)
• Cholesterol
• Potassium chloride
• Monobasic potassium phosphate
• Sodium chloride
• Dibasic sodium phosphate dihydrate
• Sucrose
• Water for injections
Question 170.
Yes. The TGA has its own quality testing laboratory with extensive expertise in testing vaccines. It is the most experienced such laboratory in the Southern Hemisphere.
During the evaluation process for provisional registration, the TGA reviews data to confirm that the manufacturing process is well controlled and sets up how the quality of the vaccine will be maintained in future batches. To ensure these standards are maintained, the TGA conducts a batch release assessment process for every batch of vaccine supplied in Australia. Every vaccine batch must pass the assessment before it is released for use.
A batch release assessment also involves testing (and/or review of testing results from an overseas regulatory laboratory that has been recognised by the TGA) to ensure the vaccine has been manufactured according to the required standards. An extensive amount of laboratory testing has been performed by the TGA on each of the COVID-19 vaccines.
