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 which was referred to the Minister of Health under the provisions of section 24(5) of the Act and set out in the Schedule hereto:

Schedule

Provisional consent is to be granted until 4 November 2022.

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 (the reference numbers have been retained from the original provisional consent conditions as per New Zealand Gazette, 4 February 2022, Notice No. 2022-go330):

2. Only batches that have been released for supply by an approved finished product manufacturing or testing site may be supplied in New Zealand.
3. 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.

5. 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.

31. Provide updated specifications for non-compendial raw materials used in the manufacture of drug substance at SIIPL that include an identity test method. Due date: 31 December 2022.

38. Provide a re-evaluation of the drug substance and finished product total protein specification limits after the statistical analysis of 30 commercial scale lots and implement a shelf-life specification for purity of active substance using SDS-PAGE. Due date: 31 August 2022.

40. Develop a purity test for finished product using SDS-PAGE and establish a release and shelf-life purity specification. Due date: 31 August 2022.

46. Inform Medsafe of any results arising during the ongoing product container leachables study that indicate unsuitability and provide the final study report. Due date: 30 September 2022.
47. Include mean particle size and polydispersity index by dynamic light scattering in the drug substance and finished product release and stability specifications. Due date: 30 September 2022.
48. Develop a CE-SDS method and provide identification of the peaks in the final electropherogram, including a discussion of the data and final confirmation of the molecular weights. Upon completion of successful method development and validation, implement justified acceptance criteria for drug substance and finished product release and stability testing. Due date: 31 December 2022.
49. Provide the final report for non-clinical study NVX 702-115. Due date: 30 September 2022.

52. Provide further efficacy and safety data from the pivotal clinical studies, including the crossover parts of the studies, within five working days of reports being produced.
53. Provide any reports on the requirement for and timing of booster doses within five working days of these being produced.

56. Investigate the ability of the vaccine to neutralise existing and emerging SARS-CoV-2 variants and provide associated reports within five working days of these being produced.
57. 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.
58. Provide the interim and final reports for clinical studies 2019nCoV-301 and 2019nCoV-302 within five working days of being produced.
59. Provide the final report for the ICMR/SII Covovax clinical study within five working days of being produced.
60. Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
61. Provide monthly safety reports, as well as all safety reviews they conduct or become aware of.
62. 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 August 2022.

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