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 until 3 November 2023.

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. 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.
2. Provide Certificates of Analysis to Medsafe for the first three batches of vaccine intended for the New Zealand market, prior to distribution.
3. To 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.
4. Provide the final clinical study reports from Study C4591007 within five working days of these being produced.
5. Provide any reports on efficacy and safety including duration and the requirement for booster doses within five working days of these being produced.
6. Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
7. Provide any safety reports and safety reviews conducted or they become aware of.
8. 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 24th day of November 2022.

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