COMIRNATY LP.8.1 (SARS-CoV-2 spike protein (mRNA) LP.8.1) COVID-19 VACCINE 3 micrograms/0.3 mL concentrated suspension for injection multidose vial, Pfizer Australia Pty Ltd, CON-1419

The products do not conform to the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91) for the following reasons: • ARTG number is not displayed on the label. Hence the text size cannot be compared to requirement [subparagraph 7(2)(d)(i) of TGO 91]. • The Approved Biological Name (ABN) for the active ingredient is ‘SARS-CoV-2 spike protein (mRNA) LP.8.1’. This ABN is not used on all labels [paragraph 8(1)(b) of TGO 91]. • On labels for the multidose vials, only per-dose strength is displayed [paragraphs 8(1)(c) and 9(1)(c) of TGO 91]. • On labels for the multidose vials, only the single dose volume is displayed (e.g. 1 dose of 0.3 mL) [paragraphs 8(1)(e), 9(1)(e) and 10(5)(d) of TGO 91]. • The batch number and expiry date on all labels are prefixed with 'Lot/Exp' [paragraphs 8(1)(f), 8(1)(g), 10(5)(e) and 10(5)(f)of TGO 91]. • Contact details are included for BIONTECH, not the Australian Sponsor, Pfizer Australia Pty Ltd [paragraph 8(1)(i) of TGO 91]. • Labels do not include the following statement: ‘PRESCRIPTION ONLY MEDICINE – KEEP OUT OF REACH OF CHILDREN’ [paragraph 8(1)(k) of TGO 91]. • 'International' label batches allocated for Australia may not contain any leaflet with instructions for use [paragraph 8(1)(l) of TGO 91]. • A machine-readable code that encodes the GTIN is not included in the label [paragraph 8(1)(n) of TGO 91]. • The international labels for the vial presentations do not have the name of the medicine presented on at least three non-opposing sites of the carton [paragraph 8(1)(o) of TGO 91]. • International labels are not compliant with the requirement, ‘The name of the medicine on the main label must be presented in a continuous, uninterrupted manner and not be broken up by additional information or background text’ [subsection 9(2) of TGO 91]. • The name of the active ingredient is not the ABN and is not located directly below the name of the trade name [paragraph 9(3)(a) of TGO 91]. • The name and quantity of each excipient in the medicine is not expressed on the labels [paragraph 10(3)(a) of TGO 91]. • The vaccine formulation does not contain an antimicrobial preservative, nor a statement on the label ‘Use in one patient on one occasion only’ Contains no antimicrobial preservative’ [paragraph 10(3)(b) of TGO 91]. • The label of the primary pack does not comply with sections 8 and 9 and subsection 10(3) [paragraph 10(5)(b) of TGO 91]. • The quantity or proportion of the active ingredient is not displayed on the labels [paragraph 10(5)(h) of TGO 91]. • The weight of the active ingredient in the container is not expressed on the labels [subparagraph 11(2)(f)(i) of TGO 91]. • The quantity of the active ingredient in one millilitre of the injection is not stated [subparagraph 11(2)(f)(iv) of TGO 91]. • The weight of the active ingredient in a stated volume of medicine is not expressed on the labels [paragraph 11(2)(l) of TGO 91].