Another EMA communication on AstraZeneca. Blood clots are ‘very rare side effects of the vaccine’

Contents

EMA: Most reported cases in women under 60 years of age
86 cases were analyzed, 18 of which were fatal
What symptoms should you worry about?
The vaccine reduces the risk of death and prevents disease
Cavaleri: There is a link between AstraZeneki and blood clots

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“People who received Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) have had unusual blood clots with low platelet counts,” writes the European Medicines Agency in a press release published today. Symptoms are also given that might indicate an adverse reaction to the vaccine.

The likelihood of a blood clot following vaccination is very low, but be aware of the symptoms, says the EMA, listing symptoms that should worry people who are vaccinated
The press release also said that a detailed analysis of 86 post-vaccination thrombosis cases, 18 of which were fatal
In an earlier press release, EMA reassured that there was no evidence of side effects from the vaccine and that “its benefits still outweigh the risks”
In mid-March, many countries around the world decided to temporarily suspend AstraZeneca vaccination after deaths in people who had previously received the vaccine
On Tuesday, EMA’s vaccine evaluation team leader Marco Cavaleri said “it is now becoming increasingly difficult to argue that there is no causal link between AstraZeneki and very rare unusual cases of blood clots”
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EMA: Most reported cases in women under 60 years of age

In the statement of the European Medicines Agency published on Wednesday, we read:

“EMA reminds health professionals and people who are vaccinated to be aware of the possibility of very rare cases of blood clots in combination with low levels of platelets within 2 weeks of vaccination. So far the majority of reported cases occurred in women under 60 years of age within 2 weeks of vaccination. Based on the evidence currently available, no specific risk factors have been confirmed.

Vaccine recipients should seek immediate medical attention if they develop symptoms of this combination of blood clots and low platelet count »

The Risk Assessment Committee noted that the cases of blood clots involved veins in the brain (cerebral venous thrombosis, CVST) and the abdomen (visceral vein thrombosis), along with low levels of platelets and periodic bleeding.

Expert: There is a link between AstraZeneki vaccine and blood clots

86 cases were analyzed, 18 of which were fatal

As reported in Wednesday’s EMA report, the Risk Assessment Committee conducted a detailed analysis 62 cases of cerebral sinus thrombosis i 24 cases of splanchnic vein thrombosis reported in the EU medicines safety database (until 22 March 2021), of which 18 ended in death. The cases came mainly from the spontaneous reporting systems of the European Economic Area and the United Kingdom, where around 25 million people received the vaccine, the release reads.

COVID-19 is associated with the risk of hospitalization and death. A reported combination of blood clots and low platelet counts is very rare and the overall benefits of the vaccine in preventing COVID-19 outweigh the risk of side effects.

One of the likely explanations for the combination of blood clots and low platelet count is an immune response leading to a condition similar to what is sometimes seen in patients treated with heparin (heparin induced thrombocytopenia, HIT). The Risk Assessment Committee has requested new studies and revisions to them to keep them informed and will take any necessary further action.

What symptoms should you worry about?

As we read in the EMA release, patients who have the following symptoms should seek medical help:

dyspnoea
chest pain
swelling of the leg
persistent abdominal (abdominal) pain
neurological symptoms including severe and persistent headaches or blurred vision
small spots of blood under the skin other than where the injection is given

The vaccine reduces the risk of death and prevents disease

I also read in the EMA release: Vaxzevria is one of four vaccines approved in the EU to protect against COVID-19. Research shows that it is effective in preventing disease. It also reduces the risk of hospitalization and deaths from COVID-19.

The EMA also ensures that, as with all vaccines, the EMA will continue to monitor the safety and effectiveness of the vaccine and provide the public with the latest information.

According to the authors of the study, by April 4, 2021, a total of 169 cases of CVST (thrombosis of the venous sinus of the brain) and 53 cases of splanchnic vein thrombosis were reported to the EudraVigilance system (the European system for reporting, among others, adverse drug reactions). By that date, some 34 million people had been vaccinated in the European Economic Area and the United Kingdom.

Cavaleri: There is a link between AstraZeneki and blood clots

Marco Cavaleri, head of the vaccine evaluation team of the European Medicines Agency (EMA), said on Tuesday that “it is now becoming increasingly difficult to argue that there is no causal link between AstraZeneki (against COVID-19) and very rare unusual cases of blood clots. blood ».

In an interview with the Italian daily Il Messaggero, he referred to an in-depth study of cases of thrombosis in people over 55, mainly women, explaining that the work was “far from over”.

— In my opinion, we can already say that, it is clear that there is a link to the vaccine. However, he stated that the EMA did not yet know “what causes this reaction,” Cavaleri explained.

In mid-March, EMA announced that AstraZeneca’s COVID-19 vaccine is safe and effective. The director of the European Medicines Agency (EMA), Emer Cooke, said then that the administration of the preparation was not associated with an increased risk of blood clots.

– It is a safe and effective vaccine. Its benefits in protecting people from COVID-19 outweigh (…) the risks. The vaccine is not associated with an increase in the overall risk of a blood clot in people who receive it, said Cooke.

The agency also acknowledged that the vaccine «may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of platelets (elements in the blood that help clotting), with or without bleeding, including rare cases of blood clots in the bloodstream. blood drainage vessels from the brain (CVST) ».

Earlier, more countries announced temporary halt to the vaccine after isolated cases of death.

Where were vaccinations with AstraZeneka stopped? [LIST OF COUNTRIES]

At the same time, numerous institutions assured that the vaccine was safe and that its widespread use should not be abandoned.

There is no reason to stop using the AstraZeneki vaccine, says WHO. There are more and more organizations in the world that are of the same opinion

The AstraZeneki vaccine is also used in Poland. It is given, inter alia, teachers and people under 69 who are vaccinated according to the immunization schedule.