COVID-19 vaccine strain updates

Purpose

This guidance describes how we intend to review applications for the registration of COVID-19 vaccines that reflect variations to existing COVID-19 vaccines and that are designed to confer protection from newly identified variants of concern (VOC). This guidance will assist in enabling safe and efficacious vaccines to be rapidly available for COVID-19, where these new vaccines have been developed from existing COVID-19 vaccines.

Scope

• This guidance only applies to vaccines against VOC where a closely related form of the same COVID-19 vaccine has full registration on the Australian Register of Therapeutic Goods (ARTG).
• Variants of concern will be confirmed by us based on advice from the World Health Organization (WHO) and a public health risk assessment of new variants.
• COVID-19 vaccines that are provisionally registered, or for indications with provisional registration, are out of scope for this guidance.

Approach

Applications for variant (strain update) vaccines, are to be considered under a Category 1, Type G application pathway involving an application for registration under section 23 of the Therapeutic Goods Act 1989, processed under the streamlined submission process. We aim to evaluate applications under a target timeframe of 45 working days (mRNA vaccines), which is dependent on the availability of the complete dossier and the data required to support the application. Protein-based vaccines may take more time, as they are often more complex. However, further information regarding evaluation timeframes for each specific applications will be provided at the time the application is accepted for evaluation (Milestone 2).

Under this approach COVID-19 vaccines that are targeted at new variants would, if accepted for registration, be entered in the Australian Register of Therapeutic Goods, (the Register) in their own right, and would receive their own ARTG number. This would mean that any related earlier COVID-19 vaccines would also remain in the Register.

The Advisory Committee on Vaccines (ACV) advises us of the risk-benefit assessment of COVID-19 vaccines, which can vary significantly by indicated age group and potentially variant type. Therefore, alternative evaluation approaches may be required depending on the technology platform and/or type of vaccine (e.g. mRNA, protein-based, etc.).

Evidence requirements

• We will evaluate all applications containing variant-specific changes, and will consider the strain selections, formulation, pre-clinical and animal data, information from other regulators, as well as available clinical trial and real-world post-market safety and effectiveness data from ancestral and earlier variant vaccines with the same manufacturing process. Independent advice from the ACV may be sought to inform the registration decision.
• Clinical data from earlier related COVID-19 vaccines manufactured using the same platform, including those with provisional registration, may provide supportive evidence for an application for a COVID-19 variant vaccine that is designed to address a new VOC.
• In some cases, we may require additional data and/or evidence to be provided in order to be able to evaluate safety and efficacy as part of our consideration of the Product Information (PI).
• We accept a combination of clinical trial and real-world evidence. It is anticipated that a combination of types of evidence will be provided by sponsors for the purposes of applying for the registration of such products.
• Where a sponsor provides real world evidence, such evidence is expected to comply with the principles of either the EMA or FDA guidelines. Find more information on the Real World Evidence and Patient reported outcomes page.

Dossier requirements

• We expect that all dossiers will comply with the Australian specification of eCTD.

Pharmacovigilance requirements

Additional conditions of registration may be applied where early evidence is accepted.

Transparency of submissions and changes made

We will publish either an AusPAR or an addendum to existing AusPARs for variant COVID-19 vaccines.

Pathway selection for evaluation and decision making

This section provides overall guidance to sponsors by providing examples of relevant application categories for the review of safety, efficacy and quality of vaccines, including COVID-19 vaccines:

• Case: Adjustment of variant-specific component only of mRNA-based or protein-based vaccine, with similar vaccine components (including lipid nanoparticles, adjuvant).
  • Advice: This may be considered a Category 1, Type G application if the initial/parental vaccine has full registration. We will consider each proposed application prior to acceptance via this pathway. Sponsors should apply for a new INN for each variant to facilitate registration. Please contact streamlinedsubmission@health.gov.au for further advice.
• Case: New formulation including a broader combination of active ingredients or mRNAs of very different sequences or lengths, introducing new antigens, or different types of lipid nanoparticles etc.
  • Advice: Likely requires a submission for the registration of a new entity (e.g. Category 1, Type A). See our Guidelines for Prescription Medicines page.
• Case: New formulation including changes to the excipients or to the total quantity of active included within the ingredients.
  • Advice: Likely requires a submission for the registration of a major variation. See our Guidelines for Prescription Medicines page.
• Case: New dosage, strength, dose form, route, patient group or route of administration.
  • Advice: Likely requires a submission for the registration of a major variation. See our Guidelines for Prescription Medicines page.
• Case: Requests to import, supply or export a vaccine that does not comply with standards.
  • Advice: Likely follows the normal approach for a submission under s14 of the Therapeutic Goods Act 1989. See our Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry page.