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“Today, in an hour, I received a recommendation from IWT, according to which the service, like other countries of the European Union, for precautionary reasons recommends suspending vaccination with the AstraZeneca vaccine,” reported A. Dulkys.
In a few hours: three reports of blood clots in Lithuania
For his part, Gytis Andrulionis, director of IWT, stated that the decision to suspend vaccination with AstraZeneca in Lithuania was taken in the last hours after receiving three reports of adverse reactions related to thromboembolic events.
“In the last few days, to be precise, several hours, we have received three reports of suspicious and unexpected serious adverse reactions, that is, unexpected, related to thromboembolic events in patients vaccinated with AstraZeneca in Lithuania. We do not have as much evidence to date as to whether this is due to the vaccine or simply coincided in the time after vaccination, ”explained the head of the IWT.
One case of thromboembolism was recorded in Mažeikiai, another in Šakiai and Vilnius. Adverse events were reported in women older than 80 years.
The Minister of Health, A. Dulkys, emphasized that both the European Medicines Agency (EMA) and the World Health Organization (WHO) affirm that to date there is no substantiated evidence that the vaccine can increase the risk of blood clots. .
The minister explained that vaccination centers will no longer use AstraZeneca as of Wednesday morning, but could not say exactly when the vaccination will stop. A. Dulkys hopes that the final evaluation will already be presented this Thursday.
IWT Manager: “There really are questions”
G. Idrdrionis, director of IWT, recalled that the vaccine from the manufacturer of AstraZeneca has been registered by both the European Commission and the European Medicines Agency, and the information on the benefit-risk balance of the vaccine has not changed since its registration. .
“In other words, to this day, there is no question that the benefits outweigh the risks, but we have some key aspects that led to those decisions. In particular, the latest data we have collected shows that 16 countries in the European Economic Area and the European Union have discontinued vaccination with one or all batches of the AstraZeneca vaccine.
The absolute majority of these cases are decisions made before the European Medicines Agency presents its evaluations ”, G. Andrundionis defended the decision to temporarily suspend vaccination at AstraZeneca in Lithuania.
According to the IWT chief, those evaluations have already started and will continue on both Wednesday and Thursday. A conclusion is expected to be issued on Thursday “for the evaluation of the case of the thromboembolic event.”
“But the decision to stop vaccination was made by AstraZeneca states because it will not necessarily end on the 18th. There are really questions. Both the registrant and the company itself have provided some assessments and answers, and both the European Medicines Agency as our experts are present and everyone evaluates them.
Today, preclinical and clinical data evaluations began. In other words, you look at it from the beginning, where these risks come from, what they mean and how to evaluate them ”, he explained.
G. Anddrulionis noted that no country has permanently suspended vaccination with AstraZeneca. All states have only temporarily suspended vaccination processes with this manufacturer’s vaccine until its safety is determined.
At the same time, the head of IWT emphasized that in Europe, adverse reactions to vaccines were registered in all their manufacturers, not only in AstraZeneca. However, at present, it is this vaccine manufacturer that has been under scrutiny, since the information available on possible cases of thromboembolism was not mentioned in the description of adverse reactions.
Threat to the vaccination plan?
A.Dulkys admitted that if the use of the AstraZeneca vaccine were stopped in Lithuania for a longer or permanent period, due to the reduction in the number of vaccines, the vaccination itself would be prolonged. “It will affect the vaccination plan quite significantly. We are still talking about significant volumes of vaccines in the second quarter of the year. We will also update the vaccination schedule next week.
Unfortunately, the volumes that Pfizer is increasing and how much it would decrease due to the loss of AstraZeneca are still difficult for me to balance. All in all, I see a slowdown in vaccination. Hopefully these doubts will be cleared up as soon as possible (…) I believe that efforts will be made to add up all the points and clarify as soon as possible ”, the minister expected.
The final decision may take some time.
Rugilė Pilvinienė, Senior Advisor to IWT’s Pharmacovigilance and Poisoning Information Unit, explained that the Service had closely monitored the vaccination process with AstraZeneca, as well as what was happening in other countries.
“Until the end of last week, we had not received any alarming messages. But because people read the press, are interested, follow the events (…) the impression is that some people have been encouraged by public deliberations to report reactions adverse reactions that are suspected are related to thromboembolic events after vaccination with AstraZeneca ”, – taught the specialist.
According to her, the three reported cases were serious. This has led to additional precautions: “I want to emphasize once again that our decision is not based on concrete evidence that such links exist. To date, all ongoing discussions continue to point in the direction that these are most likely findings found as a result of mass vaccination. Only more attention is paid to the disease that is already characteristic of humans.
It is a basic disease that occurs constantly, it is quite difficult to diagnose until a crisis situation occurs. What we are seeing now is a more visible manifestation and image of these disorders. Because vaccination reveals irritations that in humans might not have been associated with anything until then and would drop in statistics like the overall incidence of the disease. “
The specialist acknowledged that AstraZeneca’s security issue may not be fully resolved by Thursday. He recalled that the decisions of the parties had also changed very abruptly, so he did not rule out the possibility of uncertainties about the vaccine, but promised that this will be reported. “We really won’t keep people in the dark,” he added.
The EVA said Tuesday there were “no signs” that a coronavirus infection vaccine developed by AstraZeneca and the University of Oxford in some cases caused blood clots in vaccinated people, despite several European countries temporarily suspending the drug. due to the accusations.
The European Union Pharmacovigilance Authority emphasized that it remains “firmly convinced” that the benefits of the drug outweigh the risks. “We remain firmly convinced that the benefits of AstraZeneca in preventing COVID-19 with the associated risk of hospitalization and death outweigh the risks of this side effect,” said Emer Cooke, EEA Director.
Several European countries have temporarily suspended vaccination with AstraZeneca for fear of a risk of blood clots. Among them, Latvia, Germany, France, Italy, Spain, Norway, Denmark, the Netherlands.
