COVID-19 vaccine weekly safety report - 17-03-2021

Last week, the TGA received a total of 411 AEFI reports for COVID-19 vaccines. This includes the first 88 AEFI reports for the AstraZeneca COVID-19 vaccine. The most common adverse events reported for COVID-19 vaccines during this period were:

• headache
• fever
• muscle pain
• fatigue
• nausea

Adverse events reported to the TGA may not be caused by the vaccine. Learn more about causality.

Not all adverse events are reported, especially for minor and well-known side effects. Learn more about reporting levels.

The information the TGA receives in reports reflects the view of the reporter. As analysis of these reports is ongoing, the information may change as data quality is reviewed or further information is provided. Total numbers may also change as duplicate reports are identified.

Analysis of adverse event reports by product received up to and including 7 March 2021

Comirnaty BNT162b2 (mRNA) – Pfizer Australia Pty Ltd

Frequently reported adverse events

The most frequently reported adverse events for the Comirnaty vaccine were:

• Headache
• Nausea
• Dizziness or feeling faint
• Injection site reaction

The occurrence of these adverse events is consistent with what is already known about the Comirnaty vaccine. Headache, nausea and injection site reaction were commonly reported adverse events in clinical trials. Dizziness or feeling faint is a common reaction to vaccination that can be caused by the body’s reaction to pain or feeling anxious about an injection.

Adverse events of special interest

The TGA, like other vaccine safety monitoring programs around the world, closely monitors for specific adverse events known as ‘adverse events of special interest’. This close monitoring helps us to confirm the safety profile of COVID-19 vaccines, particularly with respect to possible side effects that may occur rarely. We conduct analyses to compare the number of reports of these events against the expected rate of events.

Adverse events of special interest reported for the Comirnaty vaccine were:

• Anaphylaxis (6 reports)
• Facial weakness (3 reports) 
• Seizure (1 report)
• Stroke (1 report)

Anaphylaxis is a very rare side effect that may occur with any vaccine and occurred in clinical trials of Comirnaty. We are reviewing the 6 cases of possible anaphylaxis to determine whether they are consistent with true anaphylaxis. The rate of possible anaphylaxis reported in Australia is consistent with the rate expected for vaccines in general. Information collected from the global use of Comirnaty suggests the rate of anaphylaxis does not exceed the rate expected for vaccines in general.

Routine vaccination procedures include keeping people under observation for 15 minutes after vaccination and having appropriate medical treatment on hand so that anaphylaxis can be rapidly managed, if it occurs. A second dose of Comirnaty should not be given to those who have experienced anaphylaxis to the first dose.

Facial weakness or paralysis has been reported rarely in clinical trials for Comirnaty. It can also occur around the time of immunisation for reasons not related to the vaccine. The number of reports of facial weakness received in Australia is no higher than the expected background rate in Australia. We are continuing to closely monitor these events closely.

Seizures are being monitored because of a theoretical link with vaccines, while stroke is being monitored because of a theoretical link with COVID-19 disease. Our review does not suggest an increased risk of these or any other adverse event of special interest associated with Comirnaty.

Further information about Comirnaty can be found in the Consumer Medicine Information.

Active surveillance

AusVaxSafety is an active vaccine safety surveillance system that complements the TGA’s enhanced safety surveillance activities. Active vaccine safety surveillance uses SMS and a short survey to collect reports of AEFI directly from a subset of people receiving the vaccines. AusVaxSafety is an Australian Government-funded system that shares its findings with the TGA to assist our safety investigations and responses.

See details of AusVaxSafety’s latest COVID-19 vaccines safety data.

The AusVaxSafety findings support the TGA’s assessment that the COVID-19 vaccines used in Australia meet safety standards.

Other TGA safety information

During the past week, the TGA has published the following COVID-19 safety-related information:

AstraZeneca ChAdOx1-S COVID-19 vaccine – 12 March 2021 (updated 16 March 2021)
The TGA is aware that some European countries have paused vaccination with the AstraZeneca ChAdOx1-S COVID-19 vaccine after reports of blood clots following vaccination. The TGA advises that a link between blood clots and the AstraZeneca vaccine has not been confirmed. To 11 March 2021, the TGA has received no reports of blood clots following use of the AstraZeneca ChAdOx1-S vaccine in Australia.

AstraZeneca ChAdOx1-S COVID-19 vaccine – 19 March 2021
The TGA is closely reviewing reports of anaphylaxis after four cases were reported following the AstraZeneca ChAdOx1-S vaccine in the past two days in Queensland. Anaphylaxis is a form of allergic reaction. It is a very rare side effect that may occur with any vaccine.

Useful links

TGA COVID-19 vaccines hub

Australian Government Department of Health COVID-19 vaccines hub

AusVaxSafety