Could AstraZeneki vaccine be restricted or withdrawn? Dr. Andrzej Ryś explains the EMA’s decision

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Does Wednesday’s EMA announcement mean people with thrombosis or vascular problems should be careful with AstraZeneki? Do young women have cause for concern? And can the product be withdrawn from the market? We asked the Polish representative at EMA, dr. Andrzej Rys.

In a statement released on February 7, the European Medicines Agency identified blood clots as a “very rare side effect” of the use of AstraZeneca vaccine
Previously, the EMA analyzed 86 cases of thrombosis after receiving the vaccine, 18 of which were fatal. These cases occurred in a group of approximately 25 million vaccinated with this type of vaccine
In a Wednesday press release, EMA also said that “so far most reported cases have occurred in women under 60 years of age within 2 weeks of vaccination”
At the same time, the agency continued to maintain a positive recommendation for AstraZeneki, explaining that the overall benefits of the vaccine in preventing COVID-19 outweigh the risk of side effects.
– Research on this preparation is ongoing, we are constantly talking in the EMA group – explains Dr. Andrzej Ryś, director of healthcare systems, medical products and innovation at the European Commission, member of the Governing Board of the European Medicines Agency
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Karolina Świdrak, MedTvoiLokony: Is the EMA decision groundbreaking? For the first time, the agency said that there was a link between AstraZeneca and the occurrence of blood clots in vaccinated people.

Dr Andrzej Ryś: Already in the previous decision, the EMA signaled that the problem occurs, but it was only a suspicion. It has now been confirmed that there is a link between thrombosis and vaccination. This is true for a very small number of cases, but it is there. EMA confirmed the cause and effect relationship between both elements.

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

What should people who are interested in getting vaccinated understand from this message? What information does it provide for healthcare professionals?

In the European Medicines Agency communication, we talk about three different problems. The first important piece of information is this: the risk of getting COVID-19 from not getting the vaccine is much higher than the risk of very rare side effects from vaccination. Second conclusion: blood clots are a problem that mainly affects women under the age of 60.

The third element has to do with vaccine campaigns in individual countries. Where the epidemic is raging and access to vaccines is limited, the AstraZeneki vaccine continues to be a very important part of the war against the virus. But further decisions will be made in individual countries, and it is the countries that will take action in this matter.

Does the EMA message mean that people with a history of thrombosis or with vascular problems should be careful with this vaccine?

No, this could not be confirmed. The mechanism behind the formation of blood clots after vaccination in specific people is also not entirely clear. We suspect that this is an immune response resulting from a very specific pattern of traits in the bodies of patients who have had such problems. But the whole relationship is not clear, it is not known what triggers or promotes such a reaction.

What is the risk of blood clots after vaccination? Dr. Grzesiowski explains

So what do we know about adverse vaccine reactions?

First of all, they are very rare, this is the most important piece of information. We are talking about less than 200 cases of side effects among 34 million people who are vaccinated.

Can we read in the EMA announcement who is most exposed to the adverse effects of vaccination with AstraZeneki?

A similar warning also applies to other vaccines for cases of anaphylactic shock. Someone who has had it once – for example, in response to a bee bite or given a dental anesthetic – is believed to be more likely to experience shock again, for example after receiving the vaccine. But this is a different type of problem – something has occurred in the past and is a warning for the future.

In the case of AstraZeneki, we did not notice such a relationship. We are not yet able to answer the question whether any feature or situation in the past may increase the risk of blood clots after vaccination.

There is no warning in the EMA communication for any particular group – neither in terms of age, nor gender or health. The agency lists only symptoms that should increase the vigilance of vaccinated people.

There are two communications in the agency’s position. One – to doctors, nurses who conduct vaccinations. He shows what symptoms to look out for in vaccinated people. There is also a second message for patients – this is a list of symptoms that patients can observe on their own and go to the doctor waiting for help.

Watch out for such symptoms after AstraZeneka. These are signs of a thrombosis

So we are not yet able to identify specific diseases or burdens that increase the risk of side effects?

No, we were unable to confirm this. Perhaps it will be possible in further research. EMA has established an independent team of experts, specialists in hematology, cardiology and neurology, to advise the committee. This issue is under surveillance and research continues.

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

The announcement states that the abnormal response to the vaccine is similar to an immune response, leading to a state similar to what is sometimes seen in patients treated with heparin. It’s also a fairly general wording – we can see the similarity, but we don’t understand it very well.

The entire COVID-19 phenomenon is unknown to us. We are constantly researching it, we are constantly learning something new. We already know that the disease itself increases the risk of thrombosis. We are learning more and more about the long-term effects of COVID-19. We knew before that it mainly attacks older people, now we see that there are more young people. The disease itself caused by this virus is still under investigation, and we have only known it for over a year. Experts compare the course of this complication to a rare reaction after the administration of heparin.

Is there a risk that AstraZeneki will be withdrawn from use? Or that its use will be limited to specific groups, for example, by gender and age?

It is hard to judge, this is not the moment yet. As EMA wrote in a press release, this vaccine offers a tremendous opportunity to increase our safety. Both individual and population.

I am asking this because the UK immunization council has just announced that the vaccine is not recommended for people under the age of 30.

A possible decision on restrictions among vaccinated people is an individual decision of Great Britain, which was made after an analysis of the situation in that country.

Each country assesses the risk on the basis of “risk-benefits”, that is, compares the risk with possible positive effects. As the risk of negative effects is greater in older populations, the more positive effects will outweigh negative effects. This is also the logic of the British decision.

Vaccine-related thrombosis? The doctor explains

This is what it looks like from the perspective of the good of the entire population

Yes, but also an individual person. If I, as a 60 plus person, have a greater chance of an unfavorable COVID-19 transition, and at the same time the risk of a blood clot is minimal, close to zero, it means that the positive effects outweigh the negative ones.

What’s next for the AstraZeneki vaccine? The registry of adverse symptoms will be continued, and the EMA will analyze them and make further decisions?

Research is ongoing. Yesterday, the British Medicines Regulatory Agency (MHRA) announced that AstraZeneca had decided to suspend vaccine trials in adolescents to wait for the risk of blood clots to be assessed by the EMA and the UK Medicines Agency. More studies are ongoing, and the EMA’s position is that the positives still outweigh the negatives.

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Can the European Union’s recommendations and recommendations regarding this preparation change?

We talk all the time. The recommendation of the Risk Assessment Committee (PRAC), released on Wednesday, will be further processed by the EMA. At the moment, however, the vaccine is recommended. Let us not get ahead of events and decisions.

However, I would like to emphasize that the European drug and vaccine safety oversight system is currently one of the most advanced systems in the world. As a result, we have a high level of public health protection throughout the European Union. The European Commission will monitor the situation and is ready to take appropriate action if necessary.

Could AstraZeneki vaccine be restricted or withdrawn? Dr. Andrzej Ryś explains the EMA’s decision

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