Purpose
This information 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). It will assist in enabling safe and efficacious vaccines to be rapidly available for COVID-19, where these new strain (variant) vaccines have been developed from existing COVID-19 vaccines.
Scope
- This information only applies to new strain (variant) updates to where a closely related form of the same COVID-19 vaccine has full registration, by the same sponsor, on the Australian Register of Therapeutic Goods (ARTG).
- COVID-19 vaccines that are provisionally registered, or for indications with provisional registration, are out of scope for this guidance.
Approach
Applications to update a new strain (variant) update for COVID-19 vaccines, will generally be considered a new chemical entry, and will be evaluated under a Category 1 Type A (reduced fees) application pathway involving an application for registration under section 23 of the Therapeutic Goods Act 1989, processed under the streamlined submission process.
We will 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 application 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 strains (variants) would, if accepted for registration, be entered in the ARTG 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 ARTG.
The Advisory Committee on Vaccines (ACV) will continue to advise the TGA of the risk-benefit assessment of COVID-19 vaccines, which can vary significantly by indicated age group and potentially strain (variant) type. Therefore, alternative evaluation approaches may be required depending on the technology, manufacturing process and/or vaccine type (e.g. mRNA, protein-based, etc.).
Evidence requirements
- We will evaluate all applications containing strain (variant)-specific changes and will consider the strain selections (variant recommendations), formulation and manufacturing quality data, 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 strain (variant) containing COVID-19 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 manufacturing process, including those with provisional registration, may provide supportive evidence for an application for a COVID-19 strain (variant) vaccine that is designed to address a new strain (recommended variant).
- In some cases, we may require additional data and/or evidence to be provided to be able to evaluate safety and efficacy as part of our consideration of the Product Information (PI).
- We will 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
All dossiers will comply with the Australian specification of eCTD.
Pharmacovigilance requirements
Additional conditions of registration may be applied where early evidence is accepted.
Fees and charges
Application and evaluation fees associated with an application to register a vaccine for a new strain (variant) of COVID-19, where the vaccine is closely related to an existing vaccine for another strain (variant) that is included in the ARTG for the same Sponsor, are covered under fee items 2(bcb) and 4(ac), respectively, in Clause 3 of Schedule 9 of the Therapeutic Goods Regulations 1990.
Current summary of fees and charges to applications submitted to the TGA.
Transparency of submissions and changes made
AusPARs will be published, or an addendum to existing AusPARs for strain (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 strain (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, reduced fee 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 new strain (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. standard Category 1 (not a reduced fee application). 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.
For more information, and prior to submitting your PPF, contact the Application Entry Team at: AET.APPLICATION.ENTRY.TEAM@health.gov.au