COVID-19 vaccine weekly safety report - 19-08-2021

More rapid publication of adverse event reports received by the TGA

Due to strong public interest in side effects relating to COVID-19 vaccinations, and improvements in our IT systems, we are publishing reports of suspected side effects to vaccines and medicines more rapidly. These changes align with the TGA’s Digital Transformation project which over the coming years will digitise, transform and modernise our business systems and infrastructure and allow for greater transparency.

Previously, de-identified reports were made publicly available in the Database of Adverse Event Notifications (DAEN) 90 days after they were completed by staff at the TGA. From 18 August 2021, this information will be released 14 days after reports are accepted into the TGA’s internal database. Reports are being made public prior to in-depth TGA analysis of the data. The weekly report will continue to provide up-to-date safety information on COVID-19 vaccines.

Following the change, more than 30,000 additional adverse event reports are now visible in the DAEN. This reflects the availability of more recent reports combined with the greatly increased rate of reporting for COVID-19 vaccine adverse events arising from the millions of COVID-19 vaccines administered in Australia over a short period of time. We encourage reporting of adverse events even if people are uncertain whether it is related to a vaccine. Therefore, publication of an adverse event report does not necessarily mean that it is related to the vaccine. Some events would have happened anyway, regardless of vaccination. This is particularly the case when millions of people are being vaccinated.

It is important when looking for information about COVID-19 vaccines to consider whether the source of the information is credible. Useful websites such as ‘COVID vaccines – is it true?’ can address false claims and misleading rumours. Other reliable resources are listed at the end of this report.

Most commonly reported vaccine side effects

The most common adverse effects reported to the TGA following immunisation are predictable and have been observed with many vaccines. They include headache, muscle pain, fever, chills and injection site reactions for both vaccines.

Monitoring of less common adverse events

The TGA, like other vaccine safety programs around the world, is continually monitoring for less common adverse events. This helps us to confirm the safety profile of COVID-19 vaccines, particularly for rare side effects. We conduct analyses to compare the number of reports against the expected rate of these events.

The TGA recently carried out a detailed investigation of reports of facial swelling following immunisation in people who have had dermal filler injections. As described below, nothing unexpected was found but we continue to monitor this side effect as part of our routine vaccine surveillance activities.

Facial swelling in people who have had dermal filler injections

After reports from overseas, the TGA investigated facial swelling following vaccination in people who had received injections with dermal fillers (soft, gel-like substances injected under the skin). We identified two reports with the Comirnaty (Pfizer) vaccine which involved swelling and tenderness of the cheeks, eyes and, in one of the cases, lips. Both individuals had received dermal filler injections in these areas previously. A reaction was also reported at a dermal filler injection site following vaccination with the AstraZeneca vaccine but the report contained limited information about the adverse event.

After reviewing cases reports and data from the scientific literature, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee considered that there is a reasonable possibility that these side effects could be caused by the Comirnaty (Pfizer) vaccine. These types of reactions can be triggered by the immune system after a viral or bacterial illness, vaccinations such as the influenza vaccine and dental procedures. Symptoms respond to treatments, such as oral corticosteroids and hyaluronidase, but often resolve on their own.

These are extremely rare and temporary side effects. Given the protective benefits of vaccination outweigh the very small risk of these reactions, people who have previously received injectable dermal fillers should not be discouraged from getting vaccinated. Similarly, there is no need to avoid dermal fillers in the future for those who are already vaccinated.

We continue to routinely monitor these types of side effects following vaccination and encourage people to report reactions that they suspect are related to the COVID-19 vaccination.

Latest immunisation recommendations

COVID-19 outbreak

As the COVID-19 outbreak involving the Delta variant continues to grow, the risk of contracting COVID-19 disease remains significant. Data from the NSW outbreak demonstrates that vaccination protects people from infection and even in the small number of vaccinated people who become infected it significantly reduces the severity of disease. In an outbreak, ATAGI continues to encourage all people over the age of 18 years to strongly consider getting any available vaccine, including the AstraZeneca vaccine.

Vaccination during pregnancy and lactation

The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and ATAGI recommend immunisation with the Comirnaty (Pfizer) vaccine at all stages of pregnancy. This is due to the risk of complications from COVID disease for pregnant women and their unborn baby. To date, no serious pregnancy-related safety concerns have been identified with Comirnaty (Pfizer). 

Pregnant women who have already received a first dose of the AstraZeneca vaccine can get either the Comirnaty (Pfizer) or AstraZeneca vaccine for their second dose. The Pfizer vaccine is recommended for breastfeeding women who can continue breastfeeding before and after vaccination. More details are given on the RANZCOG website.

AstraZeneca COVID-19 vaccine

To 15 August 2021, approximately 8.1 million doses of the AstraZeneca vaccine have been administered in Australia. We continue to receive reports of suspected side effects to the vaccine. These are generally consistent with what is being observed internationally and most are expected side effects that resolve within a few days.

Thrombosis with thrombocytopenia syndrome (TTS)

TTS is a rare event involving serious blood clots with a low blood platelet count. It is triggered by the immune system’s response to the AstraZeneca vaccine and is different from other clotting conditions.

The latest rates of TTS in Australia were published in a statement from ATAGI on 12 August 2021.

While TTS is very rare, some people may have concerns that they can discuss with their doctor. 'Weighing up the potential benefits against risk of harm from COVID-19 Vaccine AstraZeneca' includes information to help people make informed decisions about vaccination.

TTS cases to date

Since last week’s report, a further 8 reports of blood clots and low blood platelets have been assessed as confirmed or probable TTS likely to be linked to the first AstraZeneca vaccine dose. Five of the individuals were aged 60 years or over (Table 1).  

‡As previously reported, the TGA determines whether a report is likely to represent TTS by assessing cases against accepted criteria established by the UK’s Medicines and Healthcare products Regulatory Agency.

In addition to the new cases reported today, two cases previously reported as probable TTS have been reclassified as confirmed TTS. This takes the total Australian reports assessed as TTS following the AstraZeneca vaccine to 112 cases (62 confirmed, 50 probable) from approximately 8.1 million vaccine doses. 

Some of the cases reported last week are possibly related to the second vaccine dose. These remain under investigation and will be considered by an external panel of experts in the coming week to determine whether they are linked to vaccination or not. All of the cases were in older people who presented with relatively mild symptoms, including common clots in the lungs or leg that are not uncommon with advancing age. All patients have been discharged from hospital. Expert review of previous similar cases found them unlikely to be TTS.

People who have already received their first AstraZeneca dose who have not experienced TTS should complete the two-dose schedule. To date, there are no TTS cases in Australia that have definitively been linked to a second dose of the AstraZeneca vaccine. Investigations overseas have shown that the risk of TTS after the second dose is extremely low (for example, 1.8 cases per million based data from the UK).

When assessed against the criteria used by the US Centers for Disease Control and Prevention (CDC), fewer than half of the cases reported to the TGA are classified as Tier 1 cases which tend to have more serious outcomes. Tier 1 cases involve clots in an unusual location, such as the brain or abdomen (Table 2). 

In Australia, severe cases of TTS appear to be more common in women in younger age groups. Nearly half of the TTS cases in women required treatment in intensive care. Cases meeting the criteria for Tier 1 were also twice as likely to occur in women compared to men. 

No deaths have been reported in the last week. Six deaths have been reported over the preceding 4 months – 5 of the 6 deaths occurred in women aged 34, 48 (2 cases), 52 and 72-years-old. The other death was in a 44-year-old man. 

† The US CDC classification is defined as:

• Tier 1 = clots in an unusual location (such as the brain or abdomen) and a low platelet count with or without antibodies that activate platelets (anti-PF4 antibodies)

• Tier 2 = clots found in common locations (such as the leg or lungs) and a low platelet count and anti-PF4 antibodies

• Not classified = case does not meet the criteria for Tier 1 or Tier 2 (for example clots in common locations with low platelet count but no evidence of anti-PF4 antibodies).

Cases have most often occurred about 2 weeks after vaccination, although the time to onset (or diagnosis) has ranged from one to 83 days (Table 3). To date, cases presenting with a longer time to onset (over 50 days) have been designated as probable cases and have presented with common forms of clots. It can be difficult to distinguish between normal clots and TTS for these cases and they remain under investigation. As more is learnt about TTS internationally, we are considering modifying our case criteria, such as including the time to onset of symptoms as part of the criteria for confirming TTS. If the criteria are updated, it may result in some cases being reclassified as unlikely to be TTS because they present such a long time after vaccination and/or are likely to be due to other causes.

*Data is based on the most recent medical information available to the TGA

On 1 July 2021 we reported on the case of a woman who died of suspected TTS in the UK 5 weeks after receiving her first dose of the AstraZeneca vaccine in Australia. At that time, we advised that she had another serious underlying health condition. Information received subsequently indicates that she did not in fact have an underlying condition. Once more, we pass on our sincerest condolences to the woman’s family and loved ones. 

Other safety signals with the AstraZeneca vaccine

Immune thrombocytopenia (ITP)

The TGA continues to monitor and investigate reports of suspected ITP, a type of thrombocytopenia or low platelet count. We will communicate the outcomes of this investigation, including any regulatory actions, when it is complete. To 15 August 2021, the TGA has received 47 reports of suspected ITP following vaccination. These patients had an extremely low platelet count, and signs of thrombocytopenia which may include unusual bruising, a nosebleed and/or blood blisters in the mouth. Their symptoms occurred in a timeframe that suggested they could be linked to vaccination and no other obvious cause was identified based on the information provided to TGA. However, apart from one fatal case that was assessed by an expert Vaccine Safety Investigation Group as being likely to be vaccine related, these cases have not been definitively linked to vaccination.

ITP can occur when the immune system is activated, for example by a viral infection or vaccination, and mistakenly destroys platelets which help blood to clot. In many cases it is mild with up to a third of people having no symptoms at all, or only minor bruising. However, about 5% develop severe bleeding.

We encourage people to seek medical attention if they experience signs and symptoms that could suggest ITP, such as unusual skin bruising or clusters of small red or purple spots that do not lose their colour when pressed. Unusual bleeding is another sign, for example bleeding from the nose or mouth that is hard to stop, or blood in the urine or stools.

Guillain-Barre Syndrome (GBS)

The TGA has investigated reports of suspected GBS following vaccination with AstraZeneca vaccine.

At this time, we are unable to establish a clear link between GBS and the AstraZeneca vaccine. International drug regulators have come to similar conclusions. As a precautionary measure, we have initiated discussions with the sponsor about potentially adding a warning to the Product Information.

GBS is a rare immune disorder in which the body’s immune system attacks nerve cells. The causes are not fully understood, but it often follows a viral infection (such as influenza, cytomegalovirus and glandular fever) or gastroenteritis caused by a bacteria called Campylobacter jejuni. GBS has been associated with other types of immunisations, such as influenza vaccines and has been reported with COVID-19 infection. GBS causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking. It tends to affect both sides of the body. In many cases symptoms resolves within months but can sometimes take up to 2 years.

To 15 August 2021, the TGA has received 82 reports mentioning GBS occurring after vaccination with the AstraZeneca vaccine. These cases will be considered as part of our ongoing monitoring of this signal.

We encourage people to seek medical attention if they experience symptoms that could suggest GBS as early medical care can reduce severity and improve outcomes. Symptoms to look out for include weakness and paralysis in the hands or feet that can progress to the chest and face over a few days or weeks.

Up-to-date information about the expected side effects of the AstraZeneca COVID-19 vaccine can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Comirnaty (Pfizer) vaccine

To 15 August 2021, approximately 7.2 million doses of Comirnaty (Pfizer) have been administered in Australia. Reports of suspected side effects of the Comirnaty (Pfizer) vaccine received by the TGA are consistent with what has been observed in the clinical trials and by other medicine regulators overseas.

Myocarditis and pericarditis

Following investigations by the TGA and international drug regulators, a warning statement about myocarditis (inflammation of the heart) and pericarditis (inflammation of the membrane around the heart) has been included in the Consumer Medicine Information and Product Information for Comirnaty (Pfizer). To 15 August 2021, we have received 188 reports of suspected myocarditis and/or pericarditis following vaccination with Comirnaty (Pfizer).

These rare effects on the heart typically occur within 10 days of vaccination, particularly after the second dose of Comirnaty (Pfizer) and more often in younger men. While cases are usually transient and resolve following rest, some patients require treatment in hospital. 

We know that myocarditis and pericarditis are much more common with COVID-19 infection and damage to the heart is frequently severe after infection. ATAGI, in collaboration with Cardiac Society of Australia and New Zealand (CSANZ), have emphasised that the protective benefits of the Comirnaty (Pfizer) vaccine greatly outweigh the risk of these rare side effects. The vaccine continues to be recommended for individuals aged 16 years and above and for those aged 12–15 who have an increased risk of severe illness from COVID-19 or who identify as Aboriginal and Torres Strait Islander.

We encourage people to seek medical attention if they experience symptoms that could suggest myocarditis or pericarditis including chest pain, palpitations (irregular heartbeat) fainting or shortness of breath after receiving the vaccine, particularly if they occur within 1–5 days. Initial tests for those presenting with symptoms include ECG, troponin and chest X-ray.

Up-to-date information about Comirnaty (Pfizer) can be found in the Consumer Medicine Information (for consumers) and Product Information (for health professionals).

Useful links

Australian Technical Advisory Group on Immunisation (ATAGI) weekly COVID-19 meeting update – 11 August 2021 

Top 3 COVID-19 vaccine questions – Lambda variant, peak spreaders, and getting a COVID-19 vaccination whilst sick – 17 August 2021

Top 3 COVID-19 vaccine questions – Moderna, vaccine choice, and how tests differentiate between COVID and flu – 12 August 2021 

Latest advice on COVID-19 vaccination for pregnant and breastfeeding women – 6 August 2021 

Latest COVID-19 weekly surveillance in NSW

Coronavirus (COVID-19) case numbers and statistics

COVID-19 vaccines: Frequently asked questions – 15 July 2021

COVID vaccines – is it true? 14 July 2021

TGA COVID-19 vaccines hub

Australian Government Department of Health COVID-19 vaccines hub

AusVaxSafety (active surveillance activities and information) 

COVID-19 vaccine symptom checker 

Database of Adverse Event Notifications (DAEN)

Advice on COVID-19 vaccination during pregnancy – 9 June 2021

Comirnaty (Pfizer) vaccine – phase III clinical trial

AstraZeneca vaccine – phase III clinical trial