News
Blood-clot death ‘likely’ linked to AstraZeneca COVID vaccine
The TGA has confirmed the recent death of a 48-year-old NSW woman was likely linked to the vaccine: ‘A causative link to vaccination should be assumed at this time’.
This article was updated at 11.10 am Sunday 18 April to include advice from the TGA.
Australia appears to have recorded its first vaccine-related fatality.
The Therapeutic Goods Administration (TGA) has confirmed the recent death of a 48-year-old NSW woman was likely linked to the AstraZeneca COVID vaccine.
‘Despite the atypical clinical features and the negative antibody test, in the absence of an alternative cause for the clinical syndrome, VSIG [Vaccine Safety Investigation Group] believed that a causative link to vaccination should be assumed at this time,’ the TGA said in a statement.
The announcement came after experts from the VSIG met late on Friday.
The NSW woman – who had a number of underlying medical conditions, including diabetes – died four days after receiving the AstraZeneca vaccine on 8 April, prior to the last week’s Australian Technical Advisory Group on Immunisation (ATAGI) recommendation that people aged under 50 receive the Pfizer vaccine rather than AstraZeneca.
‘The review of this case was complicated by the patient’s underlying medical conditions, including diabetes, some other medical conditions, as well as some atypical features,’ the TGA said.
‘In relation to this case, VSIG agreed that the case was consistent with causal association to immunisation although for this patient, anti-PF4 antibodies were absent.’
Anti-PF4 antibodies activate platelets and have been found in almost all other internationally reported cases of blood clots with thrombocytopenia linked to the AstraZeneca vaccine.
The NSW woman represents the third Australian report of a rare case of thrombosis with thrombocytopenia syndrome (TTS) following a dose of the AstraZeneca vaccine. With a total of 885,000 doses of AstraZeneca administered in Australia to date, the TGA calculates the frequency of TTA in the country at one in 295,000.
Both previous cases are said to be recovering in hospital.
‘The overall number of reports received for blood clots following vaccination so far has been no higher than the expected background rate for the more common type of blood clots in Australia,’ the TGA said.
‘These can occur in around 50 Australians every day separate to vaccination and are not related to the very rare TTS clotting disorder.
‘The TGA is carefully reviewing all Australian reports of blood clots following the AstraZeneca vaccine, and are requesting further information from reporters where needed to identify any further possible cases of TTS.’
Many fear that cases of blood clots and changes to the country’s rollout plans have shaken Australians’ confidence in the available vaccines, potentially making GPs’ job more difficult.
RACGP President Dr Karen Price previously told newsGP it is inevitable that GPs will need to address people’s concerns.
‘I would imagine there is going to be a lot more need to have a lot longer consultations with these people, going through a risk–benefit analysis and what it means,’ she said.
In addition, practices have reported appointment cancellations from concerned patients over the age of 50, while others have expressed concern over issues of legal liability.
The TGA has advised:
People who have received COVID-19 vaccines should be aware of the common side effects, which include fever, sore muscles, tiredness and headache. These usually start within 24 hours of vaccination and last for 1–2 days. These side effects are expected and are not of concern unless severe or persistent. The reports of these rare clotting complications have occurred later (between day four and 20 after vaccination) and have generally been severe, requiring hospitalisation.
Consumers should seek immediate medical attention if, a few days after vaccination, they develop symptoms such as:
- as a severe or persistent headache or blurred vision
- shortness of breath, chest pain, leg swelling or persistent abdominal pain
- unusual skin bruising and/or pinpoint round spots beyond the site of injection.
Dr Price also told
newsGP ‘intense’ negotiations are underway between the college and the Department of Health regarding Medicare Benefits Schedule (MBS) item numbers for the additional time required to discuss consent prior to immunisation.
‘We are advocating for a solution where a GP can take the necessary time required to provide this counselling and have a number of options on the table,’ she said.
The Australian Government recently upped its agreement with Pfizer for an additional 20 million doses, bringing the country’s total to 40 million, slated to arrive over the course of the year.
Log in below to join the conversation.
AstraZeneca blood clots vaccine
newsGP weekly poll
Is it becoming more difficult to access specialist psychiatric support for patients with complex mental presentations?