COVID-19 Vaccine Weekly Safety Report

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COVID-19 Vaccine Weekly Safety Report.

By The Therapeutic Goods Administration | Australian Government | Department of Health

The Therapeutic Goods Administration (TGA) has been closely monitoring suspected side effects (also known as adverse events) from the use of COVID-19 vaccines since the national roll-out began on 22 February 2021.

Current status

Safety data collected on the COVID-19 vaccines used in Australia is consistent with the known side effects. No new safety concerns have been identified.

Millions of people worldwide have received COVID-19 vaccines. Clinical trials and international safety monitoring have found that side effects, if they occur, are usually mild and temporary.

Learn about the TGA’s COVID-19 vaccine safety monitoring and reporting activities or report a suspected side effect.

Total adverse event following immunisation (AEFI) reports received up to 21 March 2021

Gathering reports of suspected side effects following vaccination is just the first step in determining whether or not the effect is related to the vaccine and whether a significant safety issue is involved. Learn more about how the TGA identifies and responds to safety issues.

 

AEFI reports received in the week 15-21 March 2021

Last week, the TGA received a total of 786 AEFI reports for COVID-19 vaccines, including 413 for the Comirnaty vaccine, 369 for the AstraZeneca COVID-19 vaccine, and 4 reports where the vaccine tradename was not reported. The most common adverse events reported for COVID-19 vaccines during this period were:

  • Headache
  • Fever
  • Muscle pain
  • Nausea
  • Fatigue

 

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 14 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
  • Dizziness
  • Injection site reaction
  • Nausea
  • Fatigue

The occurrence of these adverse events is consistent with what is already known about the Comirnaty vaccine. Headache, injection site reaction, nausea and fatigue were commonly reported adverse events in clinical trials. Dizziness 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 (13 reports)
  • Facial weakness (5 reports)
  • Seizure (2 reports)
  • Stroke (2 reports)
  • Deep vein thrombosis (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 13 cases of possible anaphylaxis to determine whether they are consistent with true anaphylaxis and whether they may have been caused by the vaccine. The rate of confirmed 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 and deep vein thrombosis 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.

COVID-19 Vaccine AstraZeneca (ChAdOx1-S) – AstraZeneca Pty Ltd

Frequently reported adverse events

The most frequently reported adverse events for the AstraZeneca COVID-19 vaccine were:

  • Fever
  • Headache
  • Muscle pain
  • Chills
  • Fatigue

The occurrence of these adverse events is consistent with what is already known about the vaccine. They were commonly reported in clinical trials.

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 AstraZeneca COVID-19 vaccine were:

  • Loss of sense of taste (1 report)

The loss of sense of taste is being monitored because of a theoretical link with COVID-19 disease. It may also be a non-specific symptom associated with feeling unwell. Our review does not suggest an increased risk of this or any other adverse event of special interest associated with the AstraZeneca COVID-19 vaccine.

Further information about the AstraZeneca COVID-19 vaccine can be found in the Consumer Medicine Information.

Active surveillance

AusVaxSafety(link is external) 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(link is external).

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: European and UK reviews find no proven link with blood clots – Updated 19 March 2021
  • The European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have completed preliminary reviews of the risk of blood clots in people vaccinated with the AstraZeneca COVID-19 vaccine. These reviews have found the benefits of the vaccine continue to outweigh the risks, and it is not associated with an increase in the overall risk of blood clots.
  • AstraZeneca ChAdOx1-S COVID-19 vaccine: Expert review finds no evidence of increased risk of anaphylaxis – Updated 19 March 2021
  • Independent expert review of recently reported cases of suspected anaphylaxis following the AstraZeneca ChAdOx1-S COVID-19 vaccine has concluded that there is no increased risk of anaphylaxis associated with the vaccine above the expected rate for any other vaccine. Anaphylaxis is a very rare side effect that can occur with any vaccine.
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