Published: 29 August 2023
Archived: 21 August 2024

Medicines

COVID-19 vaccine strain update application procedure

Purpose

To provide procedural guidance on updating COVID-19 vaccines to include protection against variant strains of SARS-CoV-2.

Scope

Vaccines that have been approved by Medsafe for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

The specific SARS-CoV-2 strains will be confirmed by Medsafe based on advice regarding the public health risk of new variants in New Zealand, including recommendations from international agencies.

Submission process

Vaccines with full Ministerial consent under section 20 of the Medicines Act 1981

Sponsors should submit a New Medicine Application (NMA) (2 MB, 66 Pages) to seek approval for a new version of an existing COVID-19 vaccine with an updated active ingredient composition (strain update). If the vaccine has been approved under section 20 of the Medicines Act 1981, the strain update NMA is eligible for a reduced fee and priority timelines, provided that:

1. the technological platform (i.e., mRNA, protein subunit, viral vector) for the vaccine is unchanged
2. the drug product formulation and number of serotypes, strains, antigens or coding sequences present in the vaccine remain the same
3. there is no consequential change in the indicated age range, administration route or dosage instructions for the

A priority review status will be granted to applications that meet the above eligibility criteria, with target evaluation timeframes equivalent to those for Changed Medicine Notifications (CMNs) (350 KB, 18 pages) (although this may vary depending on any additional data required to be submitted and assessed).

The change in composition should be submitted to Medsafe using the NMA category ‘New higher-risk medicine containing one or more new active substances (NCE)’, and be accompanied by a request for a fee waiver that confirms the strain update meets the above requirements.

The fee for eligible strain update NMA submissions will be partially waived to the equivalent combined fees that would be charged for a CMN under the category ‘Active ingredient method of manufacture – G3’ for the Module 3 changes, and ‘Labelling – G2’ or ‘Labelling – G3’, for the Module 1 changes. If significant clinical review is required, an additional fee equivalent to the CMN category ‘Indications and/or dosage – G2’ will be included.

Changes to the manufacturing process that are not directly related to the change in vaccine composition, and/or changes to the indicated age range or dosage regimen, are outside the scope of the strain update NMA. Sponsors are encouraged to submit any additional changes as a CMN(s) prior to submission of the strain update. Where this is not possible, the additional changes can be included as part of the strain update NMA but will incur additional fees (equivalent to the relevant CMN categories). In this instance, the strain update NMA cover letter should include a description of the changes in terms of the corresponding CMN form B categories (Word 75 KB) to assist with determining the final fee incurred.

Vaccines with provisional consent under section 23 of the Medicines Act 1981

For COVID-19 vaccines with provisional consent, any changes to the composition of the vaccine must be submitted to Medsafe as an NMA, using the category ‘Provisional consent to distribute a new medicine (clinical need), high risk NCE’. Strain updates submitted via this pathway are not eligible for a fee waiver, but can still submit a request for priority assessment.

Data requirements for COVID-19 strain update NMAs

Medsafe’s quality and clinical data requirements for COVID-19 strain update NMAs align with those of the Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA). Reference is made to the respective guidance(s) produced by these regulators, where available.

The strain update NMA for approval for a new version of an existing COVID-19 vaccine must include (but is not limited to) the following information:

Module 1: Changes to the labelling, data sheet, consumer medicine information and package insert as a consequence of the strain update. The trade name of the vaccine should include an appropriate identifier for the variant strain.

• If sponsors wish to receive early feedback on the acceptability of the updated labelling and product information, they may submit a rolling submission with relevant Module 1 information in the first tranche. This should be discussed with Medsafe prior to submission.

Module 3: The 3.2.S and 3.2.P sections impacted by the strain change(s). An overview of the changes made to these sections should be included in the cover letter.

• For further guidance refer to EMA/175959/2021 Rev.2 Procedural guidance fo variant strain(s) update to vaccines intended for protection against Human coronavirus and EMA/117973/2021 Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

Modules 4 and 5: Refer to the above EMA guidance for the expected data requirements. A Clinical Overview (Module 2.5) should also be provided that includes a critical analysis of the safety and efficacy of the variant vaccine based on the available pre-clinical, clinical trial and real-world post-market safety and effectiveness data for the variant vaccine and/or parent vaccine(s) produced using the same manufacturing process.

The application must include the following commitments:

1. to provide Certificates of Analysis to Medsafe for the first three batches of vaccine intended for the New Zealand market, prior to distribution
2. 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
3. to provide Periodic Safety Update Reports according to the same schedule as required by the EMA
4. to provide any relevant safety reports and safety reviews (conducted or otherwise become aware of)
5. to perform the required pharmacovigilance activities and interventions detailed in the agreed RMP, and incorporate any agreed updates into 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.

Medsafe may seek independent advice from technical expert and Ministerial advisory committees to inform the assessment process, as required.

This page will be updated as additional international guidance regarding the regulatory requirements for COVID-19 vaccine strain updates becomes available.