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Blood-clot death ‘likely’ linked to AstraZeneca COVID vaccine


Paul Hayes


16/04/2021 11:40:52 PM

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’.

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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.

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Dr Ian   17/04/2021 9:13:05 AM

We need to know how many Pzifer m RNA vaccines are available for high risk workers under 50 probably under 60 .
Also are there indicators of risk for this rare but devastating complication .
PPE physical distancing open air ventilation rapid PCR and antigen tests Covid 19 tests are going to be important as we move into winter .
In the U.K. it was different because of high Covid Community prevalence but still there were tradgic casualties that might well have been avoidable by rapid diagnosis of clot predisposition .


Dr John Michael Jones   17/04/2021 12:16:53 PM

We need to know how many people over 50 have developed this complication and their ages, this will make counselling and giving the vaccine to people over 50s based on actual data/evidence rather than an arbitrary line


Dr Fahd Mirza   17/04/2021 4:01:15 PM

I agree to Dr John Michael Jones comments. We also need to know the patients comorbidities who developed thromoembolic events.
It would be beneficial if a page could be run with the numbers updated on a regular basis.


Dr Nickolas Anastasis Loizou   17/04/2021 5:56:19 PM

80+ yo male with PH DVT and current DVT, would the Astrazenica vaccine be contraindicated?

Thanks
Nick


Dr Janet Kim   18/04/2021 10:01:49 AM

We need to know what sort of pre-existing conditions the people who had these clotting had. Insulin resistance, diabetes? autoimmune conditions? what is their lifestyle? Without these info we cannot advise patients , we cannot prevent it , we cannot mitigate it. I also am concerned that us medical professions are not informed as to how this is treated including using IV immunoglobulin etc. The government needs to tell us the possibility of the pre-existing condition that can cause this, and if we get it how we plan to deal with it. We need confidence. Otherwise I doubt the public will be willing to play Russian roulette with the vaccine, and their lives. I for one am terrified as I am 57 with pre-exisitng medical condition, because of clotting. If I am scared how do I encourage patients to get them with confidence? Do I just do my job or do I do a job with care? Saying this is rare does not mean anything. The approach and advise need to change. We need a choice of vaccine.


Dr Hassib Faraj   18/04/2021 9:21:43 PM

It’s big concerns that the COVID 19 vaccine is attracting too much attention and controversy. The plan is not going it was planned , a simple example is that I am working with aged care , by today the nursing home still not vaccinated and we the doctors and the staff we are not going to be vaccinated! The answer / there is not enough Pfizer vaccines available. While the authorities claiming that the first round is finished and. They started the second. 1b . Now we are facing the complications of the Astra Zeeika which put pressure on us to proceed with the planned vaccination as Charted , every day we have withdrawals from the listed appointments, a lot of patients asking why we don’t have a choice in which vaccine? is not enough to tell patients we will have Pfizer in October! I do believe that the medical bodies should take responsibility in charting a proper Guidelines and clear program for vaccination as we do have from immunisation registry. Now it’s a poorly organised work .


Dr Shobha Balu   25/04/2021 9:24:33 AM

I received my first Astra Zeneca vaccine a week ago. I had a very high fever causing delirium and severe myalgia due to which I was in bed for more than 24 hours, totally delirious and unwell. This lasted for 24 hours. The next day I felt sort of ok. I attended my all day clinic on the 2nd day after receiving the vaccine. I am dreading about the second shot. Would love to get some feed back from any colleagues who may have come across such reactions among themselves or their patients. Dr Shobha Balu