Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicine set out in the Schedule hereto:

Schedule

Provisional consent is granted for a period of two years.

This consent is given subject to the following conditions.

The New Zealand Sponsor must fulfil the following obligations within the timelines specified, which may be altered by mutual agreement with Medsafe:

1. Prepare a "Dear Healthcare Professional" letter or comparable instructive material and provide this to Medsafe for review and approval prior to distribution of the product. Due date: 30 June 2022
2. The New Zealand site of batch release will only release batches for distribution in New Zealand once the sponsor has verified that the shipping temperature profile meets specifications.
3. Provide Certificates of Analysis to Medsafe for the first three batches of vaccine of each presentation intended to be distributed in New Zealand, prior to distribution.
4. Provide 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, or any other certification agreed with Medsafe on request, for all batches distributed in New Zealand.
5. Provide updated degradation profile results using a thermal denaturation procedure that been optimised for use with the drug substance. Due date: 31 December 2022.
6. Provide data to support validation of the bioburden method used to test the drug substance. Due date: 31 December 2022.
7. Provide data to support the establishment of 240 hours as the proven acceptable range for time under refrigerated storage during drug product manufacture. Due date: 31 December 2022.
8. Provide process validation data for the following commercial scale batches. Due date: 31 December 2022.
• Two PPQ batches of mRNA-1273 DP for Rota line at RECIPHARM site.
• Three PPQ batches of mRNA-1273 DP at ROVI site (both Marchesini and Dara line).
• Five PPQ batches of 4800 g SM-102 LNP at Moderna TX; and Five 200 g mRNA-1273 LNP batches at Moderna TX.
9. Provide shipping validation data for the following components/routes. Due date: 31 December 2022.
• mRNA-1273 LNP transported to ROVI and RECIPHARM sites for fill and finish.
• mRNA-1273 DP transported between ROVI and Alloga sites.
• mRNA-1273 DP transported from ROVI and RECIPHARM sites for the Australian supply.
10. Provide complete validation data for the analytical procedures used to test DSPC. Due date: 31 December 2022.
11. Provide full validation studies for the UPLC method used for identity, assay and purity testing of SM-102. Due date: 31 December 2022.
12. Provide full validation studies for the GC-FID, ICP-MS, IR spectroscopy, UV-visible spectroscopy and LC-MS analytical methods used to test SM-102. Due date: 31 December 2022.
13. Provide complete validation data for the analytical procedures used to test PEG2000-DMG. Due date: 31 December 2022.
14. Provide process validation data for a minimum of three PPQ batches of both PEG2000-DMG and SM-102. Due date: 31 December 2022.
15. Provide updated data to support the suitability of drug product release and shelf-life specifications with regards to degradation products and RNA integrity. Due date: 31 December 2022.
16. Provide batch analysis data for at least three commercial batches from the ROVI and RECIPHARM drug product manufacturing sites. Due date: 31 December 2022.
17. Provide any reports on the duration of efficacy and the requirement for booster doses within five working days of these being produced.
18. Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced.
19. Provide the final Clinical Study Reports for Study P203 within five working days of these being produced.
20. Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
21. Provide monthly safety reports, as well as all safety reviews they conduct or become aware of.
22. Perform the required pharmacovigilance activities and interventions detailed in the agreed RMP and any agreed updates to the RMP. An RMP should be submitted at the request of Medsafe or whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important milestone being reached.

Dated this 17th day of June 2022.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).