Lithuania temporarily suspends vaccination with AstraZeneca – pending clarification from European Medicines Agency

The Minister said that the recommendation of the Office would be taken into account.

The Minister trusts the vaccine

“I just want to emphasize that, as far as is officially known, both the European Medicines Agency and the World Health Organization say that today there is no solid evidence that a vaccine can increase the risk of blood clots. The head of the EVA said at a press conference Tuesday that the benefits of the vaccine outweigh the risks.

However, the final conclusions and assessments will be made on Thursday, ”said A. Dulkys, emphasizing that on Thursday there will be conclusions based on all the information collected and future actions.

The Minister said that when hundreds of thousands of people are vaccinated, various reactions of the organism occur, as well as logistical difficulties arise, many questions arise.

“Personally, I trust the AstraZeneca vaccine, I believe that soon we will receive all reasonable responses from European and world services. When the opportunity arises and the time comes, I will be the first to be vaccinated with this vaccine,” said the Minister of Health.

It remains to be expected that the fears dissipate. But spreading them alone won’t be enough.

A.Dulkys did not hide that such a decision would certainly have consequences for the entire vaccination. They are already there.

“We just realized that the fears would dissipate. But dispersing them alone will not be enough now. I hope that both the vaccine manufacturer will make efforts to strengthen its reputation and that we will have to make additional efforts to get back to normal,” he said. the minister.

According to the minister, Lithuania has a good distribution of vaccines, so in this case there should be no major vaccination disorders, although the more vaccines, the greater the mass of vaccinated. However, AstraZeneca also reduced the supply of the vaccine, said A. Dulkys, who emphasized that Latvia supported the vaccination process with this vaccine.

As the supply of the Pfizer-BioNTech vaccine increases, it is expected that the overall intensity of vaccination will not change much. Although if an unfavorable decision is made for the AstraZeneca vaccine, the vaccination will slow down, as A. Dulkys says.

“Hopefully these doubts are resolved as soon as possible, because a large number of states have stopped vaccinating.” “I am trying to understand with common sense that both manufacturers and services will try to put points on i as soon as possible and give clarity,” said the minister.

Currently, about 41,000 are unvaccinated. AstraZeneca vaccines. According to A. Dulkis, “there are only a few thousand” of “modern” vaccines left and there are about 40,000 “Pfizer-BioNTech” vaccines in vaccination centers. dose.

3 cases of serious side effects have been reported.

Gytis Andrulionis, director of the State Medicines Control Agency (VVKT), stated that this vaccine was registered on the basis of the evaluation carried out by the European Commission and the European Medicines Agency (EVU). Both then and now, the information about the relationship between the vaccine and your risk remains unchanged; there is no question that the benefits outweigh the risks.

However, 16 European Union countries have already suspended vaccination with one or all batches of AstraZeneca vaccines. Lithuania will be the 17th country in the EU.

EVU conclusions on the impact of this vaccine on thromboembolic events are expected on Thursday. However, G. Anddrulionis does not rule out that March 18. There may not be a final solution yet, as there are many problems.

He recalled that the ICD had already suspended the use of a series of vaccines until all the data on the safety of the vaccine were available and could be used without any doubt.

We have no evidence that this is due to the vaccine or it simply coincided in time after vaccination.

“That decision is being made precisely because we have received three reports in recent days of suspicious and unexpected serious adverse reactions related to thromboembolic events in AstraZeneca vaccinated patients in Lithuania.

We have no evidence that this is due to the vaccine or it simply coincided in time after vaccination. All the tests are transmitted to a common network and the EEA Committee assesses them together. Therefore, like other countries, our service recommended SAMe as a precaution to stop vaccination with the COVID-19 AstraZeneca vaccine until final responses to the EVA are submitted, ”said G. Andrdrionis.

It happened in three women

IWT adviser Rugilė Pilvinienė said council specialists monitor reports of vaccine side effects not only in Lithuania, but also in other countries.

“When we learned about the reported cases of people suffering from serious health problems or even dying from thromboembolic events, we closely followed the events and evaluated the reports in our country. At the end of last week, we had not received any alarming reports.

But because people follow the information, they are interested, they follow the events, the impression is that some people have been prompted by public deliberations to report adverse reactions that are suspected of being related to thromboembolic events after vaccination with AstraZeneca. We received several such reports, “said R. Pilvinienė.

But because people follow the information, they are interested, they follow the events, the impression is that some people have been encouraged by public deliberations to report adverse reactions.

There were three reports of serious adverse events on thromboembolism, one on thrombophlebitis, and two on established or suspected pulmonary embolism, that is, clot retention in the pulmonary vasculature.

These reports prompted additional precautions, but, as R. Pilvinienė stated, this recommendation does not mean that IWT believes that these complications in humans were caused by the vaccine. According to the specialist, vaccination reveals diseases that in humans would not be related to anything until then, but would be in the statistics.

Serious women over 80 have experienced serious side effects, depending on age and gender, and this is the group of people who get the disease. R.Pilvinienė recommended to check all his vaccinated health status. One woman is from Mažeikiai, one from Šakiai and one from Vilnius.

R. Pilvinienė also said that there is a known case in which a person vaccinated with another vaccine also developed thrombosis. In more detail, he stated that he was unable to comment because all the reports had not yet been examined very carefully.

G. Anddrulionis stated that side effects of other vaccines are also seen, but now the main focus is on the AstraZeneca vaccine, because a signal was received that was not detected in clinical trials.

No evidence provided, only recommended

“I hope this problem is solved much sooner. And for those people who have been vaccinated with the first dose of this vaccine, the second time will come only in May,” said A. Dulkys.

I would very much like to see only professional decisions and I want to avoid any political decisions when it comes to human health, the quality of vaccines, etc.

The minister also clarified that the vaccine will not be vaccinated at vaccination centers on Wednesday. And the EEA’s decision is expected on Thursday, and then there will be another decision if necessary.

“It just came to our notice then. But it’s important to hear that our service has also not provided any specific evidence, but is simply recommending following the safest solution and will likely carry out its own relevant investigations as well.

I would very much like there to be only professional decisions and to avoid any political decisions when it comes to human health, the quality of vaccines, etc. We hope that the competent authorities will respond as soon as possible, because the people who work in them really feel the responsibility now. The vaccine throughout the EU ”, said the Minister of Health.

G. Anddrulionis added that he would present his recommendations to the Ministry of Health as soon as he had reliable data that the doubts had been dispelled.

A.Dulkys will only be vaccinated by AstraZeneca

Previously, A.Dulkys, responding to questions from Seimas members, stated that to clear up doubts about the safety of the AstraZeneca vaccine, he promises to vaccinate it only when his vaccination line arrives, writes BNS.

The minister also confirmed that politicians are likely to be vaccinated in the second quarter of this year, when larger shipments of the vaccine arrive in the country.

“Personally, I will be vaccinated with AstraZeneca, certainly not any other vaccine, to allay fears. “It is not that easy with AstraZeneca, because a lot of international knowledge is being spread, but at this time, at this time I really do not have any information that allows me as Minister of Health to stop the vaccination process with this vaccine,” Dulkys said during the Seimas session on Tuesday.

“No symptoms”

The European Medicines Agency (EMA) said Tuesday that “there was no indication” that a vaccine against coronavirus infection developed by AstraZeneca and the University of Oxford in some cases caused blood clots in vaccinated people, although several European countries have suspended the drug due to the accusations.

The European Union pharmaceutical regulator emphasized in a virtual press conference that it remained “firmly convinced” that the benefits of the drug outweigh the risks.

According to data from the Statistics Department this Tuesday morning, a total of 360,801 vaccines have already been used in Lithuania, 260,616 people were vaccinated with the first dose of the vaccine and 100,185 with two doses.

So far, Lithuania has received 115.7 thousand. AstraZeneca vaccine dose of approximately 74,000 people. The last shipment arrived on March 12, amounting to 14.4 thousand. doses that were distributed to the municipalities.