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:
|Product:||COVID-19 Vaccine AstraZeneca|
|Active Ingredient:||ChAdOx1-S 100GVP/mL|
|Dosage Form:||Solution for injection|
|New Zealand Sponsor:||AstraZeneca Limited|
|Manufacturer:||Amylin Ohio Inc, Ohio, United States of America|
Provisional consent is to be granted for nine months.
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:
- Prepare a “Dear Healthcare Professional” letter or comparable instructive material and provide this to Medsafe for review and approval prior to distribution of this product. Due date: 16 August 2021.
- 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 copies of signed GMP certification, where only unsigned EudraGMP certification has been provided in the application, except where GMP certification has been issued the UK or France regulatory authorities. Due date: 31 August 2021.
- Provide batch analysis data for all pre-PPQ and PPQ drug substance batches when completed. Additional release and characterisation data as well as new results for degradation stability studies should be completed for Catalent Maryland, MS, US; Oxford Biomedic, Oxford, UK; and Henogen S.A, Belgium. Due date: 31 December 2021.
- Provide an updated drug substance process validation Section S.2.5 of the dossier with completed validation reports, a description of differences between the manufacturing sites, and a listing of all lots included in process validation and corresponding lot release data. The completed validation reports must include final PPQ validation reports for the drug substance and comparability analysis (for three drug substance batches) for each drug substance manufacturing site. The comparability data should include degradation trend comparison. Due date: 31 August 2021 for Catalent Maryland, MS, US, and Oxford Biomedic, Oxford, UK; 31 January 2022 for Henogen S.A., Belgium.
- Provide a review of the acceptable ranges of the CPPs and the non-criticality of the NCPPs after the drug substance manufacturing process validation has been completed at three manufacturing sites. Due date: 9 August 2021 for Catalent Maryland, MS, US, and Oxford Biomedic, Oxford, UK; 31 January 2022 for Henogen S.A., Belgium.
- Provide additional drug substance stability data and analysis to confirm the storage period at -90°C to -55°C, 2°C to 8°C, and 23°C to 27°C/55-65% RH storage conditions (for Process 3 and 4), for the pre-PPQ lots and three PPQ lots manufactured at each drug substance commercial site at the 3, 6, and 12 month and study completion timepoints within five working days of submission to the EMA.
- Provide additional finished product stability data to confirm the storage period with Process 4 batches from both the EU and the Amylin Ohio, US drug product manufacturing sites at the 3, 6, and 12 month and study completion timepoints within five working days of submission to the EMA.
- Report the recalculation of the average loss of infectivity rate during finished product storage at 2 to 8°C based on commercial process stability data at the 3, 6 and 12 month timepoints within five working days of submission to the EMA. If needed the release specification should be changed in order to ensure that batches will remain within shelf life specification during storage and handling via submission of a Changed Medicine Notification.
- Provide additional clinical justification of the end of shelf life specification. This may come in the form of additional immunogenicity data from clinical studies for participants primed and boosted with a Low Dose (LDLD) as well as characterisation of break through cases, i.e. the infectivity characteristics of the batches with which these individuals were immunised. Due date: 31 March 2022.
- Review the drug substance and finished product comparability ranges for future comparability exercises when more manufacturing experience is available. Due date: 9 August 2021.
- Provide the commercial scale process intermediate hold time validation studies completed for the Catalent Maryland, MS, US, and the Henogen S.A., Belgium drug substance manufacturing sites. Due date: 9 August 2021 for Catalent Maryland, MS, US; 7 February 2022 for Henogen S.A., Belgium.
- Provide validation of tangential flow filtration membrane lifetime for the Henogen S.A., Belgium drug substance manufacturing site. Due date: 9 August 2021.
- Validate and implement the transgene expression test for drug substance and finished product testing in all testing sites via submission of a Changed Medicine Notification. Due date: 30 September 2021.
- Review the drug substance specification with drug substance analysis data after 30 batches have been manufactured and tested. Due date: 30 September 2021.
- Review the possibility of including the transgene expression assay in the drug substance stability studies. Due date: 9 August 2021.
- Provide the analytical results for the water loss study being completed for the finished product container closure system. Due date: 7 October 2021.
- Provide in-use stability testing of an additional finished product batch, which is towards the end of shelf-life. 31 December 2021.
- Review the finished product appearance specification after 100 finished product batches have been manufactured and tested. Due date: 30 September 2021.
- Review the finished product specification when more finished product analysis data becomes available. Due date: 30 September 2021.
- Provide a finished photostability study that is performed in accordance with ICH Q1B. Due Date: 7 January 2022.
- Provide the finished product leachable study report within five working days of this being produced.
- Provide further efficacy and safety data from studies COV001, COV002, COV003, and COV005 including the final pooled analysis and Final Clinical Study reports within five working days of these being produced.
- Provide any reports on the requirement for and timing of booster doses within five working days of these being produced.
- Provide the primary analysis of study D8110C00001. Due date: 9 August 2021.
- Provide the Final Clinical Study report overview and summaries of Study D8110C0001 within five working days of these being produced.
- Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
- Provide monthly safety reports according to the same schedule as required by the EMA, 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 23rd day of July 2021.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).