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Thrombosis is a very rare side effect following the administration of AstraZeneki. The disease is more common in younger women (under 60). Cardiologist dr hab. Bartosz Hudzik, MD, in an interview with Medonet, explains what this may be the result of and why the benefits outweigh the potential risks.
- On April 7, the European Medicines Agency issued a release announcing that a rare side effect of AstraZeneki vaccines may be thrombosis
- The disease may occur within 14 days of administration of the preparation (some sources say it may be up to 21 days)
- Cardiologist dr hab. Bartosz Hudzik explains which symptoms should arouse anxiety after taking the preparation
- The doctor also talks about groups of patients who are not advised to vaccinate with AstraZeneka
- More current information can be found on the Onet homepage.
Dr hab. n. med. Bartosz Hudzik is a cardiologist and specialist in internal medicine.
And also an employee:
- III Department and Clinical Department of Cardiology of the Silesian Center for Heart Diseases in Zabrze
- Department of Cardiovascular Diseases Prevention in Bytom, Medical University of Silesia in Katowice
Agnieszka Mazur-Puchała, Medonet: The position of the European Medicines Agency of April 7 is unambiguous – the AstraZeneki vaccine may cause thrombosis. We know that this side effect is more common in younger women, under the age of 60. But do we know why this may be so?
Dr hab. n. med. Bartosz Hudzik, internal medicine specialist, cardiologist: We know that most of the thrombotic events occurred within 14 days of vaccination with AstraZeneki and were associated with a reduction in the number of platelets (thrombocytopenia). The majority of these patients were women under the age of 60. But not all of them. Roughly 10 – 20 percent. cases of thrombosis following AstraZeneki have been reported in men. It is difficult to say why the most cases were reported in relatively young women. This may be because in the UK and Germany it is mostly women who have received the vaccine. And now the question arises, is it not the vaccine delivery system that is responsible for the observed increase in the incidence of thrombosis episodes in women? We don’t know that.
Does the thrombosis following COVID-19 vaccination differ in any way from that seen in the general public?
These are primarily thrombotic events in atypical vascular locations – such as venous sinus thrombosis in the brain and visceral vein thrombosis. Thrombosis is very rare in the general population at these locations. First of all, it concerns patients with thrombophilia, that is, hypercoagulability of the blood.
EMA at a conference on April 7 said 22 cases of thrombosis had been reported as of March 86, of which 62 were in the cerebral venous sinuses and 24 in visceral vein thrombosis. Of these 86 cases, 18 were fatal. In turn, the analysis carried out on April 4 shows that 169 cases of thrombosis of the venous sinuses of the brain and 53 cases of thrombosis of visceral veins were identified in the European Union and the United Kingdom. This is roughly equivalent to 1 in 1 million people vaccinated. It is estimated that, depending on the country, this rate varies from 4 to 10 cases per 1 million people vaccinated.
Why actually COVID-19 vaccine can cause thrombosis? Can this be explained in some way?
We already have some clues about what can cause a thrombotic event after receiving the AstraZeneki vaccine. It turned out that in some patients with thrombosis in atypical location, thrombocytopenia was also observed. In the general population, thrombocytopenia is most commonly associated with a bleeding tendency. After vaccination, we are dealing with thrombocytopenia and thrombosis. A similar mechanism is sometimes observed in patients given heparin – an anticoagulant drug (heparin-induced thrombocytopenia – HIT). When the patient’s body begins to produce antibodies against the combination of heparin and platelet factor, thrombocytopenia, platelet activation and thrombosis also occur. For thrombotic events associated with thrombocytopenia following AstraZeneki, the acronyms VIPIT (vaccine-induced prothrombotic immune thrombocytopenia) and VITT (vaccine-induced immune thrombotic thrombocytopenia).
Note, however, that it is not only the AstraZeneki vaccine that causes thrombosis in rare cases. For the Pfizer vaccine, the EMA reported 35 cases of cerebral venous thrombosis per 54 million doses administered. In the case of the Moderny vaccine, this is 5 cases out of 4 million vaccinations. Three people developed thrombosis with thrombocytopenia after administration of 4,5 million Johnson & Johnson vaccines.
Since it is already known that there is a risk of thrombosis following a vaccine, people at risk should not be excluded from the vaccination program?
There are comments that patients using hormone replacement therapy or hormonal contraception should not be vaccinated because it increases the risk of thrombosis. The same applies to people with diabetes or those with atrial fibrillation. It is not exactly like that. All of these situations increase the thrombotic risk, but by a different mechanism. In the case of thrombosis with thrombocytopenia, which we observe after vaccination with AstraZeneki, we are probably dealing with an autoimmune mechanism.
Last week, the Polish Society of Hematologists and Transfusion Medicine (PTHiT) developed a path to follow in connection with the EMA announcement. Experts do not advise against vaccinating AstraZeneki in the general population. However, they indicate two groups of patients who are not advised to use this preparation – these are patients who have had a history of documented or probable thrombosis with heparin-induced thrombocytopenia and patients who have a history of venous sinus thrombosis in the brain. Moreover, experts suggest careful observation of patients with a history of venous thromboembolism or at increased risk of its occurrence. These include, but are not limited to, women using hormonal contraception. If such patients are not currently taking anticoagulants and have received the AstraZeneki vaccine, experts recommend observing them for 20 days.
The EMA has listed six symptoms following AstraZeneki that could indicate a developing thrombosis. These symptoms are easy to ignore. What are the risks of ignoring them? How soon should the patient contact the doctor after their occurrence?
The symptoms indicated by the EMA and PTHiT are not characteristic. We all can have a headache, especially after vaccination. However, patients vaccinated with AstraZeneki should be alert to the sudden onset of these symptoms, their severity or persistence. The symptoms listed by the EMA point to three areas of thrombosis. Headache, blurred vision and convulsions is a possible symptom of cerebral venous sinus thrombosis. Persistent abdominal pain indicates thrombosis of the visceral veins. Shortness of breath and chest pain is a symptom of a pulmonary embolism. All these conditions can be life-threatening. On the other hand swelling of the leg (possibly accompanied by leg pain) may indicate lower limb venous thrombosis, which may also lead to pulmonary embolism. These symptoms need attention, and not only after the AstraZeneki vaccine.
According to the EMA announcement, thrombotic events have also occurred very rarely after vaccines from other companies. The longer the delay after the symptoms appear, the worse the condition the patient can go to the hospital. This, in turn, reduces the chances of healing him and saving his life. Experts of the Polish Society of Hematologists and Transfusion Medicine have also prepared a diagnostic and therapeutic algorithm for these patients.
Post-vaccination symptoms that may be a sign of thrombosis:
- Shortness of breath or shortness of breath
- Chest pain
- Swelling or asymmetrical pain in the leg
- Persistent abdominal pain
- Blurred vision, seizures, or persistent headache
- Small spots of blood under the skin other than where the vaccine was injected
The EMA announcement states that the benefits of receiving the AstraZeneki vaccine outweigh the risks. Rightly?
Let’s look at the numbers. According to English data, 1 person in 250 may have thrombosis. Annually, the risk of thrombosis is 1 in 2 thousand. women using hormonal contraception and 1 in 1 thousand. passengers on long-haul flights. For comparison, according to the British Winton Center for Risk and Evidence Communication, the risk of death due to COVID-19 in the 25-year-old age group is 23 per 1 million cases, and in the 55-year-old group it is 800 per 1 million cases.
Following the COVID-19 vaccine, thrombotic events are statistically very rare. It’s good that we know that such a complication occurs. This allows for a quick response. I agree with the position of EMA and PTHiT. The benefits of using all three COVID-19 vaccines outweigh the risks. Thrombotic events, although very rare, are serious and must be kept in mind. But they should not be a reason not to vaccinate. However, it is important to properly conduct the screening process and to follow up patients after vaccination.
Updated position of the Section for hemostasis of the Polish Society of Hematologists and Transfusionists on the AstraZeneca COVID-19 vaccine (07.04.2021/XNUMX/XNUMX)
- We advise against vaccinating patients with AstraZeneca vaccine against SARS-CoV-2 infection with a history of a documented or probable HIT.
- We advise against vaccinating patients with a history of venous sinus thrombosis against SARS-CoV-2 infection with the AstraZeneca vaccine.
- We suggest that patients with a history of venous thromboembolism or at increased risk of thromboembolism, who are not receiving anticoagulants be closely monitored for 20 days after receiving AstraZeneca vaccine.
- We recommend that you contact your doctor if you report any of the following symptoms after vaccination with AstraZeneca between 4-20 days after vaccination: severe persistent headache, visual disturbances, seizures, focal neurological symptoms, shortness of breath, chest or abdominal pain, swelling or asymmetrical lower limb pain.
- We recommend blood counts with a smear (to exclude or confirm thrombocytopenia), D-dimer levels and imaging tests to confirm or rule out thrombosis in patients suspected of having VIPIT.
- Patients with suspected VIPIT (ie with clinical symptoms and thrombocytopenia <150 / µl and elevated D-dimer levels) should be hospitalized.
- It is advisable to consult hematology (personal or telephone) in hospitalized patients and determine their antibodies against heparin-platelet factor 4 (PF4) complexes by immunological methods; in the case of these antibodies, we suggest performing functional tests, if possible (studies not available); if functional tests are not available, further decisions should be made on the basis of the clinical picture and the results of immunological tests.
- We recommend that patients with high likelihood of VIPIT following vaccination with AstraZeneca do NOT use heparin or platelet concentrate infusions.
- In patients with a high probability of VIPIT, we recommend the use of oral direct factor Xa inhibitors (apixaban or rivaroxaban in Poland) or fondaparinux (according to the summary of product characteristics) and intravenous infusions of immunoglobulins (IVIG 1 g / kg bw / d iv min. By 2 consecutive days) and glucocorticosteroids (e.g. methylprednisolone 1 mg / kg bw / d) with regular monitoring of blood count and D-dimer concentration, preferably under the supervision of a haematologist.
- We recommend reporting all cases suspected of having VIPIT as a Rare Adverse Drug Reaction (NOP) of the medicinal product to the relevant authorities in accordance with statutory requirements.
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- What’s more likely? Death in an accident or side effects after vaccination with AstraZeneka?
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