<div>The TGA, like other vaccine safety monitoring programs around the world, closely monitors for specific adverse events known as &#8216;adverse events of special interest&#8217;. 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:

<ul><li>Anaphylaxis (33 reports)</li>
 <li>Bleeding disorder (7 reports)</li>
 <li>Facial weakness (6 reports)</li>
 <li>Seizure (6 reports)</li>
 <li>Cardiac event (2 reports)</li>
 <li>Loss of sense of taste or smell (2 reports)</li>
</ul>We are continuing to carefully review the reports of possible anaphylaxis following Comirnaty to determine whether they are consistent with true anaphylaxis and whether they may have been caused by the vaccine. Review of these cases indicates that only 11 meet the case definition criteria for anaphylaxis. Further detailed analysis of the observed rate of anaphylaxis in Australia is ongoing. Anaphylaxis remains a very rare side effect of the Comirnaty vaccine.&#160; &#160;

Guidance on the management of possible anaphylaxis remains as per the <a href="https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&amp;t=pi&amp;q=comirnaty">Product Information</a>. 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.

Bleeding and blood clot disorders, such as stroke, pulmonary embolism and deep vein thrombosis, are being monitored because of a theoretical link with COVID-19 disease. These are common conditions rather than the unusual clotting disorder associated with very low platelets (thrombocytopenia) being investigated in relation to the AstraZeneca COVID-19 vaccine.

Facial weakness has been reported rarely in clinical trials for Comirnaty.

Seizures and cardiac events are being monitored because of a theoretical link with vaccines. They can also occur around the time of immunisation for reasons not related to the vaccine.

The loss of sense of taste or smell 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 any of the above adverse events of special interest with the Comirnaty vaccine.

Further information about Comirnaty can be found in the <a href="https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&amp;t=cmi&amp;q=Comirnaty">Consumer Medicine Information</a>.
</div>

Regulatory

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 compa

COVID-19 vaccine weekly safety report - 07-04-2021

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