The Therapeutic Goods Administration (TGA) is closely reviewing reports of anaphylaxis after four cases were reported following the AstraZeneca ChAdOx1-S vaccine in the past 2 days in Queensland.
Anaphylaxis is a form of allergic reaction. It is a very rare side effect that may occur with any vaccine. The Australian Technical Advisory Group on Immunisation (ATAGI) advice emphasises that people without a previous history of specific or severe allergy should be observed post vaccination for the recommended 15 minute period. Only those with specific allergies or a previous history of anaphylaxis may require vaccination in a facility with medical staff in attendance, and to be observed for 30 minutes following administration of a COVID-19 vaccine dose. This advice can be found at: Clinical Guidance on use of COVID-19 vaccine in Australia in 2021 (v2.0) (pdf,515kb).
The TGA is conducting a comprehensive analysis of information from use of COVID-19 vaccines in Australia to date to confirm that the rate of anaphylaxis observed in Australia is consistent with the expected rate. This analysis includes:
- reviewing individual cases reported to the TGA to determine whether they are consistent with true anaphylaxis
- gathering information about whether the affected individuals have any history of allergy
- determining whether there is any clustering of common elements, such as location, batch, age or sex, that may require further investigation.
All of the Queensland reports related to vaccine from a single batch. TGA testing of the batch prior to release confirmed that it was compliant with all requirements. The TGA has confirmed that there were no temperature deviation for the batch during importation. TGA and UK have both conducted laboratory testing of the AstraZeneca vaccine prior to release as an extra safeguard. This testing has confirmed that the particular single batch of the AstraZeneca vaccine being used in Australia and administered at these Queensland sites is compliant with international standards, and is consistent with other batches of AstraZeneca vaccine supplied in Australia and safe to use.
A total of 183,006 doses of COVID-19 vaccine, including over 20,000 doses of AstraZeneca vaccine, have been administered to date in Australia. To 16 March, the TGA had received 19 reports of anaphylaxis nationally, 14 of which followed the Pfizer vaccine and 5 following the AstraZeneca vaccine. The AstraZeneca vaccine has been used in all states and territories.
This particular batch of AstraZeneca vaccine has been used extensively across the country with only one other suspected case of anaphylaxis across the entire nation.
Following the initial review the advice from TGA is the Astra Zeneca vaccine should continue to be administered as per the TGA-approved Product Information and following ATAGI advice.
Reporting problems
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.
