ATAGI met on Wednesday 18 August 2021 to review the latest developments relating to COVID-19 and COVID-19 vaccine safety. In addition, ATAGI continues to monitor COVID-19 epidemiology in Australia including current COVID-19 outbreaks involving the Delta variant, including in New South Wales, Australian Capital Territory and Victoria.
ATAGI stresses that vaccination is a key public health intervention to prevent infection, transmission and severe disease. ATAGI continues to recommend COVID-19 vaccination for all adults, and specific high-risk adolescents.
ATAGI is encouraged to note that as at 18 August 2021 over 16 million doses of COVID-19 vaccines have been administered in Australia.
AstraZeneca COVID-19 vaccine
Thrombosis and Thrombocytopenia Syndrome (TTS)
ATAGI considered an update from the Therapeutic Goods Administration (TGA) on current confirmed cases of TTS and those under investigation. The latest TGA statement on TTS cases, including clinical outcomes, can be found here.
ATAGI examined estimates of risk of TTS by age group in Australia and note that there have been 112 cases of confirmed or probable TTS (62 confirmed cases; 50 probable cases). To date around 8.1 million doses of COVID-19 Vaccine AstraZeneca have been administered.
ATAGI notes that the TGA is investigating six episodes of TTS observed in Australia in second dose recipients. International data continues to demonstrate the risk of TTS following a second dose of COVID-19 Vaccine AstraZeneca is much lower than the risk following a first dose (estimated internationally to be 1.8 per million second doses). ATAGI reinforced the importance of completing a two-dose schedule with the same brand to ensure maximal protection.
Rates of TTS cases are based on first doses of COVID-19 Vaccine AstraZeneca as of 3 August 2021 (to account for the time to onset of TTS). To that date, approximately 7.0 million doses of COVID-19 Vaccine AstraZeneca have been administered, made up of around 5.0 million first doses and 2.0 million second doses.
Although estimates of risk based on small numbers of cases are imprecise, the risk of TTS is estimated in Australia at around:
- 2.9 per 100,000 in those
- 1.8 per 100,000 in those ≥60 years.
A breakdown of current rates by decade of age for those aged ≥50 years is included here:
| Age bracket (years) | Estimated rate (per 100,000 AZ vaccinations) |
|---|---|
3.2 |
|
50-59 |
2.8 |
60-69 |
1.6 |
70-79 |
2.2 |
≥80 |
1.7 |
ATAGI also noted that the TGA included in their weekly update a detailed breakdown of Australia's confirmed and probable TTS cases using the CDC Criteria.
ATAGI noted these data suggest that the incidence of TTS is higher in younger people and the severity of TTS appears to be higher in younger women. These differences by sex are not seen in older people.
ATAGI reinforces that the benefits of vaccination with COVID-19 Vaccine AstraZeneca strongly outweigh the risks of adverse effects in all Australians ≥60 years. In the context of a COVID-19 outbreak where the supply of Comirnaty (Pfizer) is constrained, ATAGI reinforces adults younger than 60 years old who do not have immediate access to Comirnaty (Pfizer) should re-assess the benefits to them and their contacts from being vaccinated with COVID-19 Vaccine AstraZeneca, versus the rare risk of a serious side effect. In greater Sydney, all individuals aged 18 years and above should strongly consider getting vaccinated with any available vaccine including COVID-19 Vaccine AstraZeneca.
ATAGI noted the following key resources on TTS and the use of the COVID 19 Vaccine AstraZeneca:
- the ATAGI/THANZ joint statement which provides information about TTS and reaffirms ATAGI's previous advice regarding the safe use of the AstraZeneca COVID-19 Vaccine;
- the TTS primary care guide, which provides advice for providers on the consideration and management of suspected TTS cases, noting the importance of early presentation and recognition of TTS;
- the risk-benefit document, which provides advice to help consumers make informed decisions about the risks and benefits of AstraZeneca COVID-19 Vaccine in different age cohorts and scenarios; and
- additional guidance on the use of COVID-19 vaccines in outbreak settings;
- response to NSW COVID-19 outbreak; and
- additional strategies to combat the risk posed by the Delta variant of concern.
At this time, there is no update to the ATAGI statement from 17 June 2021 in relation to the use of COVID-19 Vaccine AstraZeneca, except to note that further clarification has been provided (above) in regards to its use in outbreak settings.
ATAGI continues to review and closely monitor reports of other rare but potentially serious adverse events following immunisation including: Immune Thrombocytopenia (ITP) and Guillain Barre syndrome (GBS) following COVID-19 Vaccine AstraZeneca.
Comirnaty (Pfizer)
ATAGI notes the TGA's recent registration of Comirnaty (Pfizer) for use in children aged 12- 15 years old and has provided a statement on use in this cohort and ATAGI is currently considering advice regarding a broader adolescent program.
Myocarditis
ATAGI continues to review and closely monitor reports of rare but potentially serious adverse events following immunisation following Comirnaty, including myocarditis.
ATAGI notes that the TGA has received 149 reports of suspected myocarditis and/or pericarditis following Comirnaty (Pfizer). International data demonstrates that the rate of disease is higher in younger individuals, particularly young males. Most reported cases have been mild, self-limiting and recovered quickly, although further follow-up of these cases is ongoing.
ATAGI has recently published guidance on Myocarditis and Pericarditis after mRNA COVID-19 vaccines. ATAGI reaffirms that the benefits of Comirnaty (Pfizer; currently registered for use in people aged ≥12 years in Australia) outweigh the risks of myocarditis for any age groups, and strongly recommend eligible individuals without contraindications to be offered vaccination.
