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Post-approval changes to COVID-19 vaccines
The Therapeutic Goods Administration (TGA) is responsible for assessing all COVID-19 vaccines before they can be used in Australia. We will only register a vaccine if its benefits are much greater than its risks.
For new vaccines, TGA assesses all aspects of quality, safety and efficacy of the vaccine. The initial regulatory approval decision for a particular vaccine will be limited to the manufacturing sites, storage conditions and stability information nominated and assessed in the initial application. The initial regulatory decision also often lists specific conditions of registration, some of which are updated post-approval, such as the provision of further safety information about the vaccine that is generated throughout the lifetime of the vaccine.
After the initial registration of a vaccine, the sponsor may request changes to the registration details of the vaccine. Some changes require additional assessment and approval by the TGA, before the changes to the vaccine are authorised in Australia. Approval of the changes is a new regulatory decision under our legislation, and builds on the initial regulatory decision.
It is important to note that the TGA conducts a batch release assessment for every batch of vaccine supplied in Australia. The batch release assessment is in addition to the formal regulatory decisions for initial approval and any subsequent changes.
Types of changes
Changes to a vaccine's registration details that require additional assessment by the TGA can include:
- new manufacturing sites
- chemistry and manufacturing controls
- pack size (i.e. the number of doses in a multidose vial)
- storage temperature and shelf-life (expiry date)
- tradename (brand name)
- updates to the Product Information
The sponsor must submit an application to the TGA with supporting data for the proposed changes to the vaccine.
The TGA's timeframes for assessment of the proposed changes depend on the type of change. For many types of changes, the change only affects a small part of the overall data for the vaccine, and so the assessment of the changes is relatively fast compared to the assessment for initial registration.
In all cases, the TGA is prioritising assessment of COVID-19 vaccine applications.
Example - adding a new manufacturing site
COVID-19 vaccines are manufactured across multiple global sites.
As part of the initial registration of the vaccine, the sponsor proposes which manufacturing sites will be used for supply of the vaccine to Australia. In some cases, the initial registration of the vaccine may be for a limited number of global manufacturing sites (e.g. sites A and B), depending on the proposed supply chain. After initial registration, the sponsor might decide to add another manufacturing site (e.g. site C).
For the TGA to approve site C, the sponsor must submit data to support the manufacture of the vaccine at site C. The TGA evaluates the data and makes a new regulatory decision to add site C as an approved manufacturing site for the vaccine.
Changes to COVID-19 vaccine registrations
COMIRNATY (COVID-19 vaccine Pfizer):
- 23 July 2021 - TGA Provisional Approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 years age group
- 24 May 2021 - TGA approves more flexible storage conditions for Pfizer-BioNTech COVID-19 vaccine
- 8 Apri 2021 - Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
- 13 March 2021 - Updated storage conditions: -20 °C for 2 weeks
COVID-19 Vaccine AstraZeneca: