COVID-19 VACCINE SURVEILLANCE
14.10.2021
To 10 October 2021, approximately 30.9M vaccine doses have been given in Australia 18M first doses and 12.9M second doses.
ADVERSE EVENTS REPORTED BY THE TGA
Since the beginning of the vaccine rollout to 10 October 2021, over 30.7 million doses of COVID-19 vaccines have been given.
So far, the TGA has found 9 reports of death that were linked to immunisation from 597 reports received and reviewed.
The overwhelming majority of deaths reported to the TGA following vaccination occurred in people aged 65 years and older. The deaths linked to immunisation occurred after the first dose of Vaxzevria (AstraZeneca) – 8 were TTS cases and one was a case of immune thrombocytopenia (ITP).
TTS (Clots with low platelets)
To date, there have been 152 cases of TTS assessed as related to Vaxzevria (AstraZeneca) from approximately 12.5 million vaccine doses. These cases most often occurred about 2-3 weeks after vaccination. The risk of TTS after a second dose appears to be much lower than after the first dose. Women in younger age groups seem to be slightly more likely to develop clots in unusual locations, such as the brain or abdomen, which have more serious outcomes. Eight people have died as a result of TTS – 6 of these were women. In Australia, the risk of dying from TTS after vaccination is approximately 1 in a million (people receiving a first dose), and somewhat less than this when both doses are taken into consideration.
New Cases in the past week
Overall Status
Myocarditis / Pericarditis
To 10 October 2021 for Comirnaty (Pfizer), we have received 269 reports of suspected myocarditis alone or in combination with pericarditis, with 31 of these reports in adolescents (12-17 years-old). We have also received 725 reports of suspected pericarditis alone, with 37 of these reports in adolescents. In the same period for Spikevax (Moderna), we have received one report of suspected myocarditis and 13 reports of suspected pericarditis, all in adults. These events can occur due to other causes, including common viral infections, so it is expected that not all cases are related to vaccination.
Recently, Sweden and Denmark have temporarily paused the use of Spikevax (Moderna) for those aged under 31 and 18 years respectively, based on a study in progress carried out by Danish, Norwegian and Finnish public health agencies. The final report from this study is due in a month’s time. At this time, the European Medicines Agency approval of Spikevax (Moderna) for people over 12 years of age has not changed.
Most of the patients with myocarditis experienced symptoms within 3 days of vaccination. Less than half required treatment in hospital and of those most were discharged within 4 days.
Guillain-Barre Syndrome
110 cases (1 in 97k doses)
To 10 October 2021, the TGA has received 128 reports of suspected GBS occurring after vaccination with Vaxzevria (AstraZeneca). It is expected that not all of these cases are related to vaccination as GBS can occur after common viral infections and some types of gastroenteritis.
Immune Thrombocytopenia (ITP)
To 10 October 2021, the TGA has received 83 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 with no other obvious cause based on the information provided to TGA. Apart from one fatal case that was assessed by an expert Vaccine Safety Investigation Group as being likely to be vaccine related, suspected cases of ITP have not been definitively linked to vaccination.
Weakness, lethargy, decreased appetite and night sweats
Weakness (asthenia), lack of energy or sleepiness (lethargy), decreased appetite, and night sweats (nocturnal hyperhidrosis) were added to the Comirnaty (Pfizer) Product Information in July 2021 following review of clinical trial data submitted to support use of the vaccine in adolescents. Recently, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee(link is external) also recommended that these adverse events should be listed as side effects in the European prescribing information for Comirnaty (Pfizer). These are temporary symptoms that are known to occasionally occur after vaccination. So far for the Comirnaty (Pfizer) vaccine, we have received approximately 230 reports of asthenia (weakness), 4100 reports of lethargy, 230 reports of decreased appetite and 580 reports of excessive sweating. These effects generally occurred within a day of vaccination when details were given. Lethargy was reported more often after the second vaccine dose.
Third Dos
Australians who are severely immunocompromised are being encouraged to contact their GP or specialist to discuss the possibility they may require a third COVID-19 vaccine dose to boost their protection to the highest level.
This follows advice from the Australian Technical Advisory Group on Immunisation (ATAGI) and other leading vaccination and health experts.
It is expected up to approximately 500,000 people in Australia who are severely immunocompromised may need a third dose of vaccine over the coming months.
Spikevax (Moderna) vaccine
The Spikevax (Moderna) vaccine is now being rolled out in Australia. To 10 October 2021, approximately 298,000 doses have been given. We have received 217 reports of suspected adverse events associated with the vaccine.
CLICK HERE to access the Australian Public Assessment Report
VACCINE HESITANCY MONITORING
Operation COVID Shield COVID-19 Vaccine Sentiment Summary
AusVax Safety Surveillance
As at 06 October 2021
PFIZER - More than 1% of vaccinees are going to the doctor or Emergency Department after their 2nd dose
ASTRAZENECA - More than 1% of vaccinees are going to the doctor or Emergency Department after their 1st dose
MODERNA - Just under 1% of vaccinees are going to the doctor or Emergency Department after their 1st dose
Are the adverse reactions from the vaccines putting pressure on our healthcare system?
If we are vaccinating at a rate of 1.5 million doses per week (now mostly Pfizer dose 2), that equates to 15,000+ ADDITIONAL PRESENTATIONS TO A GP OR EMERGENCY DEPARTMENT.
VACCINATIONS BY AGE GROUP
