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Thrombosis and its link with the AstraZeneki vaccine have become a hot topic again. Especially when the EMA has indicated that such a side effect is indeed possible, although it does occur very rarely. This information concerns patients with autoimmune diseases, including rheumatic diseases, which increase the risk of thrombosis. Is AstraZeneki vaccine safe for them? The Polish Society of Rheumatology took the floor.
- On April 7, EMA officially announced the occurrence of very rare cases of blood clots following vaccination with AstraZeneca
- EMA continues to recommend AstraZeneki vaccine: benefits in preventing COVID-19 outweigh risk of side effects
- Autoimmune diseases and inflammatory rheumatic diseases may be associated with an increased risk of thrombosis
- Vaccinations against COVID-19 in patients with autoimmune diseases. PTR: no data are available on the risks associated with the administration of the preparation and the increased risk of thrombosis and / or thrombocytopenia
- The PTR emphasizes that patients should not avoid being vaccinated against COVID-19
- You can find more up-to-date information on vaccinations against COVID-19 on the Onet homepage.
EMA: Blood clots are a very rare side effect of AstraZeneca
Thrombosis is a disease that has changed over the past weeks, especially in connection with the AstraZeneki COVID-19 vaccine (known as Vaxzevria). We all remember the avalanche of countries that suspended AstraZeneka vaccinations until the doubts are clarified.
While in mid-March the Director of the European Medicines Agency (EMA), Emer Cooke, announced that the administration of the drug was not associated with an increase in the risk of blood clots, on April 6, the head of the agency’s vaccine evaluation team, Marco Cavaleri, admitted that “it is now becoming increasingly difficult to say, that there is no causal link between the AstraZeneki vaccine and the very rare unusual cases of blood clots “(these words were said in an interview with the Italian daily Il Messaggero).
A day later, the European Medicines Agency, which was still investigating reports of the link between blood clots and the COVID-19 AstraZeneki vaccine, officially announced the very rare occurrence of blood clots in combination with low platelet levels within 14 days of vaccination with AstraZeneca.
So far, it is not known exactly what causes this reaction, it is probably an immune reaction. The agency also emphasized that the benefits of using AstraZeneki in the prevention of COVID-19 outweigh the risk of side effects and continues to recommend the use of this preparation.
- More on this in the article: Another EMA communication on AstraZeneca. Blood clots are ‘very rare side effects of the vaccine’
AstraZeneca COVID-19 vaccine in people at higher risk of thrombosis
Given information from the EMA, should people at risk of thrombosis be wary of Vaxzevria (this is the new name for AstraZeneca)? This question is probably asking many people at risk. Among them are people with autoimmune diseases and inflammatory rheumatic diseases. The problem was addressed by the Polish Society of Rheumatology (PTR) and the national consultant in the field of rheumatology. What is their position?
Considering the described cases of thrombosis after receiving the COVID-19 AstraZeneki vaccine, the EMA position presented above and the unclear mechanism of this type of complication, PTR and the national consultant in the field of rheumatology “note that there are currently no data available on the potential risk of Vaxzevria in patients with autoimmune diseases at a significantly increased risk of thrombosis and / or thrombocytopenia ». This is especially true of patients with antiphospholipid syndrome, systemic lupus erythematosus, systemic vasculitis and rheumatoid arthritis.
- Are there groups of patients who should not be vaccinated with AstraZeneca?
PTR reminds that thrombocytopenia very often accompanies autoimmune diseases and thrombosis associated with them. However, it should not be forgotten that in rheumatological patients there are more risk factors for thrombosis. They include, among others long-term immobilization due to disability or surgery, neoplastic disease, use of certain medications, e.g. glucocorticosteroids. Specialists emphasize that a thrombotic event is very often the result of an interaction of various factors and that the final assessment of the existing risk is made by a physician.
Vaccination with AstraZeneka and the risk of thrombosis – what should I be aware of after vaccination?
Will it be possible to modify the vaccine recommended for this patient in justified cases or with an increased risk of thrombosis and / or thrombocytopenia in a given patient? This question was addressed by PTR and the national consultant in the field of rheumatology to the Ministry of Health. So far, we do not know the position of the Ministry on this matter.
In the issued document, however, experts give the example of Great Britain. In line with UK Medicines and Healthcare Regulatory Agency guidelines, “To minimize the risk of thrombotic events, administration of Vaxzevria to patients at increased risk of thrombosis should only be considered if the benefits of protection against COVID-19 outweigh the potential risks” .
The PTR emphasizes that patients should not avoid being vaccinated against COVID-19. He reminds that those who have received AstraZeneki vaccine, and especially patients with the presence of thrombosis risk factors, should pay attention to the presence of disturbing symptoms, in particular: shortness of breath, chest pain, swelling of the lower limbs, persistent abdominal pain, neurological signs (including severe and persistent headaches or blurred vision), petechiae under the skin other than at the injection site.
- Thrombosis – causes, treatment and prevention. The six most common symptoms of thrombosis [EXPLAIN]
If such symptoms appear, it is necessary to see a doctor.
Experts in the field of rheumatology also remind that after the administration of the vaccine, the patient should avoid immobilization and ensure adequate hydration, and people taking anticoagulant therapy should absolutely continue it, as recommended by the doctor.
PTR: Patients should not avoid vaccination against COVID-19
In the published PTR position and point out a very important point. Namely, the confirmed link between thrombosis and COVID-19. According to experts, coagulation disorders occur in 20-50 percent. patients, which is associated with more than 70 percent. risk of death. Therefore, patients should not avoid vaccination against COVID-19.
- What is the risk of blood clots with COVID-19 and following vaccination with AstraZeneka?
The Polish Society of Rheumatology and the national consultant in the field of rheumatology remind that mRNA vaccines against COVID-19 (such as Comirnaty Pfizer / BionTech and the Moderny preparation) can be safely used in patients with autoimmune diseases and arthritis, as well as in people receiving drugs that affect the immune system. “So far, no negative impact of these vaccines on the course of autoimmune and inflammatory rheumatic diseases has been demonstrated, including the effectiveness of treatment (…) there is no theoretical basis to raise significant concerns in this regard” – emphasize specialists.
As for vector vaccines (Vaxzevria AstraZeneki and the Janssen / Johnson & Johnson vaccine), they can be safely used in most patients with autoimmune and arthritis and those receiving most medications that affect the immune system. As they emphasize, so far no negative impact of these vaccines on the course of these ailments and the effectiveness of treatment has been demonstrated. “(…) based on current medical knowledge, there is no theoretical basis to raise significant concerns in this regard, subject to the potential impact on clotting”.
You may be interested in:
- Thrombosis following AstraZeneca. Dr. Grzesiowski explains
- What can and should not be vaccinated against COVID-19? Dr. Fauci observes
- Will I need a third dose of the vaccine? The deputy health minister replies
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