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ATAGI issues a GP with “probable” coagulation guidance related to the COVID vaccine





The National Advisory Committee urges vaccine providers to be aware of signs of post-vaccination warnings, including new developments of severe persistent headaches that cannot be resolved with painkillers.

A woman experiencing a headache.

Symptoms onset in reported cases of central sinus thrombosis were 4 to 20 days after vaccination.

statementWas issued to healthcare providers by the Australian Immunization Technology Advisory Group (ATAGI) after a 44-year-old Melbourne man was admitted to a hospital for a blood clot.

Less than two weeks after receiving the Oxford University / AstraZeneca vaccine, a man was admitted to the hospital with fever and abdominal pain, and doctors observed abdominal thrombosis and very few thrombocytopenia (thrombocytopenia).

A clear relationship between blood clots and vaccines has not yet been established, but Professor Michael Kidd, Deputy Chief Medical Officer Said on monday The link was “likely”.

“There is no clear evidence of a causal relationship at this time, but the clinical features of the cases reported on Friday are consistent with those found in international reports of similar cases,” he said.

“The cases reported on Friday are likely to be vaccine-related, which would be consistent with its international experience. But the decisive decision, of course, is that of our Therapeutic Goods Department. It depends on the process. [TGA].. “

Thrombosis and 4-20 days after vaccination, unlike common and expected side effects of vaccination that appear within the first 24 hours and within the last 1-2 days, such as headache, muscle aches, fever, chills, etc. Symptoms of thrombosis appear.

According to ATAGI, it manifests as either central sinus thrombosis (CVST) or thrombosis at other sites such as the intra-abdominal venous system.

“The pathophysiology of this disorder appears to be accompanied by platelet activation and thrombosis, leading to platelet consumption and thrombocytopenia,” the statement said.

‘Antiplatelet antibodies have been reported in the case series. These cases appear to resemble a disorder known as heparin-induced thrombocytopenia. [HIT]However, these patients have been reported to have no history of exposure to heparin.

The “danger signal” function of CVST includes new onset of severe persistent headache that cannot be resolved by analgesia, and patients have elevated intracranial pressure (acute severe headache, vomiting, confusion), localized neuropathy and / Or it may be characteristic of a seizure.

It is not clear whether age and gender are risk factors for the syndrome, but most of the reported cases are adults under 55 years and the majority are women.

Following the controversy over the Oxford University / AstraZeneca vaccine in Europe, the timing of the incident in Melbourne has risen. Concerns about possible effects on vaccine intake..

However, infectious disease doctor Paul Griffin said: newsGP People should be assured by the “robustness” of the Australian surveillance system after vaccination.

“If there is a safety signal in any of these vaccines, not just AstraZeneca, we are confident that TGA will not hesitate to pause to assess whether it is needed.

“At this stage, what we know is [that] There is probably one event in this country that is similar to other events. However, there is still a lot of information about it.

“Obviously, the priority at this point is to respect the confidentiality of the person and try to manage them properly so that they can achieve good results. But in sufficient time, we Will know more about their presentation, and perhaps if there were other factors in addition to the vaccine.

“Since similar problems have been seen with platelets and other vaccine coagulation, COVID itself can cause similar problems, not just with AstraZeneca.

“But it has been observed really carefully and at this stage the benefits outweigh the risks. Therefore, you should continue to use this vaccine, but use it with caution.

To date, Australia has recorded one of more than 420,000 people vaccinated with the AstraZeneca vaccine for thrombosis.While Europe is reporting 1 in 210,000 And About 1 in 600,000 in the UK..

In contrast, the risk of death from COVID-19 in 65-year-olds remains 1-2 per 100 infected.

If coagulopathy is suspected, ATAGI is the patient for further investigation and expert consultation, including consultation with a hematologist, if CVST or another severe thrombocytopenic complication with thrombocytopenia is suspected. Is recommended to the clinician to refer to the hospital.

Early clinical studies include complete blood counts, D-dimer tests, and radiographic images.

‘If the screening test suggests thrombosis like HIT [low platelets <100×109/L together with elevated D-dimer 2 x upper limit of normal (ULN) or reduced fibrinogen]You should consult a hematologist or a hemostatic thrombosis specialist to advise on further investigation [including an HIT screen]”Atagi says.

Meanwhile, the advisory group warned patients experiencing symptoms given heparin or platelet transfusions that could “worse the clinical course.”

Associate Professor Griffin said it was encouraging that attention was paid to this issue.

“Because of our awareness of this, it is very unlikely that we missed the case, and we will not miss it in the future,” he said.

“Currently, there are some speculations about effective management from an IVIg perspective. [intravenous immunoglobulin], When via antibody. Hopefully, even if you find the results to be good. “

TGA and ATAGI continue to recommend the Oxford University / AstraZeneca vaccine, but European regulators are talking differently.Germany, Denmark, Latvia, Netherlands, Norway Stopped rollout while senior citizen restrictions were in effect In Finland, France, Germany, Iceland, Lithuania and Sweden.

But at this stage, Associate Professor Griffin states that this can be more harmful than good.

“I don’t think it’s justified yet. The message it sends makes it really hard to pull it back,” he said.

“It is certainly causing broader negative perceptions by those who are seeing those pauses, but do not fully understand why or why they were alleviated. Therefore, they are justified. The approach of doing it before you do it certainly tends to be harmful.

“People have a hard time navigating that information and ignore the importance of these events, so it’s a delicate balance. That’s why it encourages and educates people about where to go for reliable sources. I think we need to. “

TGA and ATAGI are expected to get more information from international regulators when they meet again on Wednesday.

ATAGI keeps That advice Patients with a history of CVST or HIT should not be vaccinated with the Oxford University / AstraZeneca vaccine as a precautionary measure until further information is available.

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AstraZeneca Blood clot Coronavirus COVID-19 (new coronavirus infection) CVST Thrombocytopenia Thrombosis vaccine

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