Dear Ministry of Health,

Please provide any and all information that has been provided to the Ministry of Health or Medsafe pertaining to the product Comirnaty (COVID-19 mRNA vaccine) with active ingredient BNT162b2:
1. Certificates of Analysis for the first three batches of vaccine distributed in New Zealand.
2. Independent batch certification, such as UK National Institute for Biological Standards and Control (NIBSC) certification, EU Official Control Authority Batch Release (OCABR) certification, Australian TGA batch release assessment for all batches distributed in New Zealand.
3. Data to further characterise the truncated and modified mRNA species present in the finished product which addresses results from ion pairing RP-HPLC addressing 5’cap levels and presence of the poly(A) tail, and addresses the potential for translation into truncated S1S2 proteins/peptides or other proteins/peptides.
4. Relevant protein/peptide characterisation data for predominant species.
5. Evaluation of any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process.
6. Analysis of the main peak of the RNA integrity test representing the full-length RNA that addresses 5’cap levels and presence of the poly(A) tail.
7. Reassessment of the active substance specification for the DNA template purity and impurities.
8. Active substance process validation data regarding the finalised indirect filter qualification assessment and the shipping validation between sites.
9. The capability of the next generation sequencing technology platform to detect lower amounts of RNA species of alternative sequence in the presence of the correct, more abundant RNA for the active substance.
10. The results and the assay suitability for the cell-based flow cytometry and the western blot method used for biological characterisation of protein expression for the active substance.
12. A summary of the validation/verification status of the immunoblot analytical procedure used to detect double stranded RNA (dsRNA) in the active substance.
13. Data comprising batch analyses of a suitable number of commercial batches as well as analyses of batches that have been used in the (ongoing) clinical trials.
14. Specifications and results of introducing an active substance to control poly(A) tail length and how it was controlled on each batch.
15. Data to support the suitability of the method used for %poly(A) tail in Q14 above.
16. Revised specifications of the mRNA integrity and polydispersity finished product.
17. Data to support the suitability of the method used for potency determination.
18. The finished product acceptance criteria for potency.
19. Control strategy assessment results for Lipid-related impurities.
20. The risk assessment with respect to the potential presence of elemental impurities in the active product based on the general principles outlined in Section 5.1 of ICH Q3D and Ph. Eur. monograph Pharmaceutical Preparations (2619).
21. Process development for ALC-0315 with emphasis on the identification and purge of impurities.
22. Specified impurities for ALC-0315 and appropriate specification limits for individual impurities.
23. Acceptance criteria for specified and un-specified impurities for ALC-0315.
24. Details about how the solvent residues that are used in the manufacture of the ALC-0315 excipient are controlled.
25. The ALC-0315 assay and impurities limits.
26. Method validation reports for assay, impurities, and residual solvents for ALC-0315.
27. ALC-0315 impurity standard information for any identified impurities reported.
28. The impact of the molecular weight and polydispersity of carboxy-MPEG on ALC-0159, including acceptance criteria, for these parameters in the starting material.
29. Reports on the duration of efficacy and the requirement for booster doses.
30. Reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, and efficacy in population subgroups.
31. The final Clinical Study Reports for Study C4591001 and Study BNT162-01.
32. The latest Safety Update Report.

Yours faithfully,
Heather

Dear OIA Requests,

Please unhide all the "acceptance criteria" that have been backend out.

Yours sincerely,

Heather Darby