You are here

Batch release assessment of COVID-19 vaccines

5 July 2021

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).

Batch release assessment is a critical part of the regulatory oversight of vaccine quality. It is especially important for vaccines that are provisionally approved, such as COVID-19 vaccines.

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 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. It is especially important for vaccines that are provisionally approved, such as COVID-19 vaccines.

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

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

ARTG Entry Name Batch Number Batch Release Completed Date Composition and Strength Result Purity and Integrity Result Identity Result Endotoxin Result
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308978P 29/6/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FC5029* 29/6/2021 In Progress In Progress In Progress In Progress
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FE3064* 25/6/2021 Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308979P 24/6/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FE3064* 23/6/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308968P 22/6/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308977P 22/6/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FA4598* 22/6/2021 Not tested. Limited batch quantity allocated for use in Pfizer Australia employee vaccination program
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FA7338* 22/6/2021 Not tested. Limited batch quantity allocated for use in Pfizer Australia employee vaccination program
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FA7812* 22/6/2021 Not tested. Limited batch quantity allocated for use in Pfizer Australia employee vaccination program
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FC8736* 22/6/2021 Not tested. Limited batch quantity allocated for use in Pfizer Australia employee vaccination program
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FC3558* 21/6/2021 Not tested. Limited batch quantity allocated for use in Pfizer Australia employee vaccination program
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308586P 15/6/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FD9234* 10/6/2021 In Progress In Progress In Progress In Progress
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FA5833* 9/6/2021 In Progress In Progress In Progress In Progress
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FC2336* 9/6/2021 In Progress In Progress In Progress Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308584P 8/6/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FD0927* 7/6/2021 Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308582P 3/6/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308583P 3/6/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 306731P 1/6/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 308178P 1/6/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 305954P 27/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 306730P 27/5/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FD0927* 27/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 305953P 25/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 305955P 25/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 305595P 20/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 305952P 20/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 304857P 18/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 305593P 18/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 305594P 14/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 305592P 13/5/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial FC3558* 13/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 304219P 11/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 304220P 11/5/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial EX6564* 7/5/2021 Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 303816P 4/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 304217P 4/5/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 304218P 4/5/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial EX6564* 1/5/2021 Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 303604P 29/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 303814P 27/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 303815P 27/4/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial EX6564* 22/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 302933P 20/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 302935P 20/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 302930P 15/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 302365P 13/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 302363P 12/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 302363P1 12/4/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial EX2405* 8/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 301779P 8/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 302359P 8/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 300165P 1/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 301777P 1/4/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 301778P 1/4/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial ET3045* 30/3/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 300157P 23/3/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 300158P 23/3/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 300160P 23/3/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial 300161P 23/3/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial ER7449* 22/3/2021 Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment Not tested, additional shipment
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial PW40043* 13/3/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial PV46672* 1/3/2021 Passed Passed Passed Passed
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) solution for injection multidose vial PW40038* 1/3/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial ER7449* 27/2/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial EP9605* 12/2/2021 Passed Passed Passed Passed
COMIRNATY (BNT162b2 [mRNA]) COVID-19 VACCINE 30 micrograms/0.3 mL concentrated suspension for injection vial EP2163* 9/2/2021 Passed Passed Passed Passed

*internationally manufactured batches