MyBody MyRisk
- Dec 13, 2021
- 5 min read

AUSTRALIA COVID-19 VACCINE SURVEILLANCE - 09.12.2021

Since the beginning of the vaccine rollout to 09 December 2021, over 39.6 million doses of COVID-19 vaccines have been given. The TGA has found 11 reports of death that were caused by vaccination from 700 reports received and reviewed.

ADVERSE EVENTS REPORTED BY THE TGA

Adverse events in under 18s

The TGA is closely monitoring reports in people aged under 18 years. To 5 December 2021, the TGA has received about 2,600 reports after vaccination with Comirnaty (Pfizer) and Spikevax (Moderna). The most commonly reported reactions are chest pain, dizziness, headache, nausea, and fever.

Deaths following vaccination

Since the beginning of the vaccine rollout to 5 December 2021, over 39.6 million doses of COVID-19 vaccines have been given. The TGA has identified 11 reports of death that were linked to vaccination from 700 reports received and reviewed. The deaths linked to vaccination occurred after the first dose of Vaxzevria (AstraZeneca) – 8 were thrombosis with thrombocytopenia syndrome (TTS) cases, 2 were linked to Guillain Barre Syndrome (GBS) and one was a case of immune thrombocytopenia (ITP).

Myocarditis / Pericarditis

Myocarditis is a known but very rare side effect of Comirnaty (Pfizer) and Spikevax (Moderna). It is usually temporary, with most people getting better within a few days. Myocarditis is reported in 1-2 in every 100,000 people who receive Comirnaty (Pfizer), although it is more common in young men and teenage boys after the second dose (8-12 cases per 100,000 doses).

To 5 December 2021, the TGA has received 389 reports which have been assessed as likely to be myocarditis from about 24.8 million doses of Comirnaty (Pfizer) and 25 reports which have been assessed as likely to be myocarditis from about 1.3 million doses of Spikevax (Moderna).

To 5 December 2021, about 24.8 million doses of Comirnaty (Pfizer) have been administered in Australia. The TGA is actively investigating reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines. Two fatal cases of an unusual form of myocarditis following a dose of Comirnaty (Pfizer) were considered by an expert group on 7 December 2021. The group determined that both cases were not consistent with being caused by vaccination.

TTS (Clots with low platelets)

Thrombosis with thrombocytopenia syndrome (or TTS) is a very rare but serious side effect of Vaxzevria (AstraZeneca). Our analysis shows it is reported in about 2 in every 100,000 vaccinated people following the first dose. The risk of TTS is much lower after the second dose (0.3 in every 100,000 vaccinated people).

From about 13.6 million vaccine doses, there have been 169 cases of TTS. Of these, 147 (83 confirmed, 64 probable) related to a first dose of Vaxzevria (AstraZeneca) and 22 to a second dose (17 confirmed, 5 probable). This includes 4 new cases of TTS reported this week (see Table 3).

New Cases of TTS

Overall Status

Guillain-Barre Syndrome

To 5 December 2021, the TGA has received 155 reports of suspected GBS occurring after vaccination with Vaxzevria (AstraZeneca). It is expected that some of these cases may not be related to vaccination, as GBS can occur after common viral infections and some types of gastroenteritis.

2 fatal cases of GBS following a dose of Vaxzevria (AstraZeneca) were considered by an expert group on 7 December 2021. The group determined that both cases were consistent with being caused by vaccination.

There is growing evidence of a possible link between GBS and Vaxzevria (AstraZeneca) following rigorous investigations of safety data by the TGA and other international regulators. In response to rare cases following vaccination, warning statements about GBS have been added to the Vaxzevria (AstraZeneca) Product Information. Further changes are expected to reflect the strengthening evidence of a possible link.

Immune Thrombocytopenia (ITP)

Risk: 1/40,000 to 1 / 100,000

To 28 November 2021, the TGA has received 93 reports of suspected ITP following vaccination with Vaxzevria (AstraZeneca). 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 the TGA.

Outcomes of Vaccine Safety Investigation Group meeting

7 December 2021

The TGA convened an external expert group to review reports of serious adverse events following COVID-19 vaccination in 5 people. This was to determine whether the events were related to vaccination. Sadly, 4 of these cases were fatal and the TGA extends its sincerest condolences for the individuals and their loved ones. The group included experts in infectious diseases, haematology, respiratory medicine, immunology, cardiology and neurology, as well as a consumer representative and an expert in communication and public health. The cases were reported to the TGA over the previous few months and had been under investigation by the TGA in collaboration with local health authorities. During this time, the TGA gathered additional information needed to accurately assess these cases, including post-mortem reports and other medical investigations. TGA convened the expert Group as soon as sufficient information was available.

The expert panel uses an internationally-accepted method developed by the World Health Organization to rate the level of certainty of a link between the event and a vaccine.

The medical conditions that were reported in these cases — Guillain-Barre Syndrome (GBS), myocarditis and multisystem inflammatory syndrome — can all have causes other than vaccination. Therefore, detailed information about the cases was needed for the panel to undertake a meaningful assessment of the possible role of vaccination.

The cases considered were:

2 fatal cases of suspected Guillain-Barre Syndrome (GBS) following vaccination with Vaxzevria (AstraZeneca).
2 fatal cases of suspected myocarditis following Comirnaty (Pfizer)
One case of suspected multisystem inflammatory syndrome following Comirnaty (Pfizer).

The VSIG came to the following conclusions:

Both GBS cases appeared likely to be related to vaccination but there was still uncertainty with this determination given the complexity of the syndrome and of the case reports. Further detail on the discussion of these cases is provided below.
The myocarditis cases were not consistent with being caused by vaccination. Further information is provided in the myocarditis section below.
For the suspected case of multisystem inflammatory syndrome, there was not enough medical information to determine if it was related to the vaccine. While the symptoms started near to the time of vaccination, there was insufficient information to diagnose multisystem inflammatory syndrome and establish a possible link to vaccination.

The TGA will continue to monitor reports of similar events and will discuss the outcomes of these reports with international regulatory agencies.

Vaxzevria (AstraZeneca) vaccine

To 5 December 2021, about 13.6 million doses of Vaxzevria (AstraZeneca) have been administered in Australia. The TGA is closely monitoring rare reports of blood clots with low blood platelets (also called thrombosis with thrombocytopenia syndrome or TTS) linked to this vaccine. We are also monitoring reports of immune thrombocytopenia (ITP) and Guillain-Barre Syndrome (GBS). See below for more details. See below for more details.

Spikevax (Moderna) mRNA vaccine

To 5 December 2021, about 1.3 million doses of Spikevax (Moderna) have been administered in Australia. The TGA provisionally approved the use of Spikevax (Moderna) as a booster dose on 8 December 2021.

The TGA is actively investigating reports of myocarditis (inflammation of the heart) and/or pericarditis (inflammation of the membrane around the heart) associated with mRNA vaccines. We continue to work with international regulators on this safety signal (see below). The Product information for Spikevax (Moderna) has been updated to include the potential adverse events erythema multiforme (frequency not known), and paraesthesia and hypoaesthesia (both listed as rare). These events were not observed in the clinical trials, but have been reported during post-market surveillance.