Batch release assessment of COVID-19 vaccines

The Therapeutic Goods Administration (TGA) ensures there is an independent quality assessment of every batch of vaccine supplied in Australia. This page provides information about the batch release assessment process for COVID-19 vaccines.

What is batch release assessment?

During the evaluation process for provisional registration, the TGA reviews data to confirm that the manufacturing process is well controlled and sets up how the quality of the vaccine will be maintained in future batches.

To ensure these standards are maintained, the TGA will conduct a batch release assessment process for every batch of vaccine supplied in Australia. Every vaccine batch must pass the assessment before it is released for use.

A batch release assessment involves one or both of the following steps:

1. A review of documents supplied by the Sponsor which describe the manufacturing process (how the vaccine is made, tested, shipped and stored)
2. TGA laboratory testing (and/or review of testing results from an overseas regulatory laboratory that has been recognised by the TGA) to ensure the vaccine has been manufactured according to the required standards

The TGA's laboratory may carry out a range of tests, including assessments for composition, identity, potency, purity and adventitious agents (contamination with microorganisms). The TGA has released a more detailed report on residual DNA and endotoxin testing.

Batch release assessment is a critical part of the regulatory oversight of vaccine quality.

What will the TGA do for COVID-19 vaccine batch release?

COVID-19 vaccines will have a priority release schedule. One of two release pathways will be undertaken:

• Pathway one - release based on overseas certification
• Pathway two - release based on TGA laboratory assessment.

Pathway one - Release based on overseas certification

Pathway one uses overseas certification as evidence that the batch has already undergone independent testing and assessment by a recognised National Control Laboratory, such as the Official Control Authority Batch Release (OCABR) process - external site in Europe.

The OCABR process involves assessment of manufacturing documentation (summary protocol review) and laboratory testing for potency, identity and appearance based on guidelines for specific COVID-19 vaccine types (e.g. RNA, viral vector, and inactivated vaccines).

When the Sponsor provides evidence that the batch supplied in Australia has passed OCABR testing, the vaccine can be released without the TGA conducting a manufacturing protocol assessment or (potentially) laboratory testing.

The Sponsor must still supply samples, batch details and evidence of the maintenance of adequate shipping conditions for the batch under this pathway.

OCABR certificates are unlikely to be available for all COVID-19 vaccine batches as their availability depends on many factors, including the final global distribution of a batch.

Pathway two - Release based on TGA assessment

Pathway two is used when no OCABR Certificate is available. In this case release of the vaccine is based upon TGA review of the manufacturing summary protocol and shipping information and testing in the TGA Laboratories.

TGA Laboratories testing results for COVID-19 vaccines

TGA Laboratories have been performing batch release and testing on all batches of COVID-19 vaccines that have been supplied in Australia. Batch release assessment is a critical part of the regulatory oversight of vaccine quality.

The information available covers all COVID-19 vaccines including the Australian manufactured AstraZeneca COVID-19 vaccine.

The table of information will be regularly updated as additional batches are assessed.