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“It just came to our attention then. (…) That study looks like any other evaluation of scientific data: you read a case, you look at what a person refers to as an adverse reaction, what a study presents. With this in Mind you, find out what deadlines the complaints meet and then see if the link between the drug and the adverse reaction is likely or not, ”said Rugilė Pilvinienė, senior advisor to the IWT Drug Surveillance and Poisoning Information Unit, BNS on Wednesday.
According to her, the link between the reports received and vaccination has not yet been established or confirmed.
On Tuesday, Health Minister Arūnas Dulkys, on the recommendation of the IWT, temporarily suspended vaccination with AstraZeneca against the coronavirus vaccine.
After three reports of thromboembolic events, the CIG recommended suspending the process until the European Medicines Agency has issued final conclusions on the safety of the vaccine.
On Wednesday, IWT reported another fourth report of a suspected thromboembolic adverse reaction. Three people are treated in hospitals, one of whom is discharged for treatment at home.
A fourth adverse reaction was reported in men older than 70 years. Three cases were previously reported in women over 80 years of age.
According to R. Pilvinienė, IWT undertakes to submit its assessment of suspected serious adverse reactions to the European Medicines Agency within two weeks and approximately mild within three months.
Cases of thromboembolism are considered a suspected serious adverse reaction.
“The messages they have sent us have so far been recorded in our database. (…) We plan (to provide a conclusion – BNS) as soon as possible, ”said an IWT representative.
The data is also analyzed by the registrant of the medicine.
According to R. Pilvinienė, after the countries have performed the national assessment, the data travels to the EEA pharmacovigilance database.
This information is available to other parties, EEA professionals and the company that registered the medicine.
“Based on these reports, registrants prepare security reports, whether monthly, yearly or in any other period,” said an IWT spokeswoman.
According to her, these notifications can also lead the EEA to initiate special procedures: investigations into certain reactions. This is exactly what happened with AstraZeneca due to reports of blood clots.
R. Pilvinienė states that the Medicines Control Agency expects a favorable assessment from the European Medicines Agency regarding the further use of the AstraZeneca vaccine.
“I believe in science, I believe in the rationality of the mind, I believe that a wise decision will be made. And whatever it is, that’s what we will respect. I would like to believe that no decision will be made that the risk-benefit balance is unfavorable. I think it will be favorable, ”said an IWT representative.
“Here is an exceptional situation, we are in a situation in which the solutions can be very different. We want to believe that tomorrow everything will be answered ”, he added.
The EVA reiterated 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, despite several European countries temporarily suspending the drug. due to the accusations.
Experts from the Amsterdam-based EEA met on Tuesday to assess the new information, and the findings are expected to be announced at a special meeting on Thursday.
A number of European countries, including France and Germany, stopped using the vaccine after reports of blood clots in some vaccinated people.
The EVA allowed AstraZeneca to be used by people of all ages in late January.
