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:
|Product:||COVID-19 Vaccine Janssen|
|Active Ingredient:||Ad26.COV2.S 100GVP/mL|
|Dosage Form:||Suspension for injection|
|New Zealand Sponsor:||Janssen-Cilag (New Zealand) Limited|
|Manufacturers:||Catalent Indiana LLC, Indiana, United States of America
Grand River Aseptic Manufacturing Inc, Michigan, United States of America
Sanofi Pasteur, Marcy L’Etoile, France
Catalent Anagni SRL, Anagni, Italy
Aspen SA Sterile Operations (Pty) Limited, Gqeberha, South Africa
Provisional consent is granted until 7 April 2024.
This consent is given subject to the following conditions:
This vaccine may only be sold to the New Zealand Government and distributed in accordance with the New Zealand Government’s COVID-19 vaccine rollout or donated to other countries.
The New Zealand Sponsor must fulfil the following obligations within the timelines specified, the dates of which may be altered by mutual agreement with Medsafe:
- 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.
- Provide Certificates of Analysis to Medsafe for the first three batches of vaccine intended to be distributed in New Zealand prior to distribution.
- 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.
- Provide additional drug substance stability data for the clinical and commercial drug substance batches 20E25-07, 20E25-14, 20G30-08, 964728, 967128, 967591, 969009, 21003042, 21003117 and 21003533 as it becomes available.
- Provide any reports on the requirement for and timing of booster doses within five working days of these being produced.
- Provide the final Clinical Study Report for the randomised, placebo-controlled, observer-blind study VAC31518COV3001 within five working days of it being produced.
- Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
- Provide monthly safety reports, as well as all safety reviews they conduct or become aware of.
- 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 8th day of March 2023.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).