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Tomorrow vaccination with the AstraZeneca vaccine against COVID-19 will resume in Bulgaria. This was made clear at a briefing by the Executive Agency for Medicines shortly after the European Medicines Agency ruled that the vaccine has more benefits than risks.
For tomorrow Work on the electronic registration system has resumed, as well as the vaccination of people who registered through the electronic portal, Deputy Minister Jeni Nacheva announced.
We have important information from the European Medicines Agency, there is an official opinion that confirms the efficacy and safety of the AstraZeneca vaccine, ie. the benefit-risk balance is positive and there is no problem for all EU member states to continue administering the vaccine, reported the director of the Executive Agency for Medicines, Bogdan Kirilov.
“We also from the Medicines Agency carry out analyzes that confirm that there are no problems in the quality of the vaccine. An analysis was made of one of the batches. We also have a conclusion from the forensic examination of the case of the deceased Plovdiv woman.
There is no thrombosis, there is no causal link, say medical experts, so at this stage we have every reason to revoke the blockade order and apply the vaccine as of tomorrow, as in the rest of European countries, “he added.
“Starting tonight we will inform those who registered for the vaccination on April 12 tomorrow morning so that they can report to the vaccination centers tomorrow and receive their first dose of the vaccine. An organization has been established through the vaccination centers, the regional health inspectorates. Vaccine quantities will be provided in the appropriate places. It is allowed, if there are people who will not show up tomorrow, to vaccinate an additional number of people who show up or are registered for the neighboring days: April 12 and 13, “added Jeni Nacheva.
“There are four important conclusions: the first is that the AstraZeneca vaccine has a positive benefit-risk balance; the second is that there are no batches in which there is a deviation in quality that can cause side effects. The third conclusion was that thromboembolism The events related to the use of this vaccine have been rejected in general, and the fourth conclusion is that there remains a small gray area of doubt in which the committee will continue its investigation, said Dr. Maria Popova, director of Pharmacovigilance Directorate. And clinical trials ”at the Executive Agency for Medicines.
According to Dr. Popova, this gray area refers to very rare cases of extremely specific syndromes, including both thrombocytopenia, that is, a small number of platelets, and the formation of blood clots associated with or without bleeding.
“They are very rare, the study will continue for them and, as they are important to human health, the committee makes recommendations that will be included in the summary and in the package insert so that patients can react in a timely manner if they happen.
There are around 400 cases that have been reported in the European database, “said Dr. Maria Popova.
These are cases of thrombosis, there are also Bulgarian cases. All such serious cases are reported within 15 days after receiving the information, the closing date of the data was March 17, until yesterday everything was included and the experts worked almost twenty-four hours a day. , to keep the information up to date.
We do not have any reaction in the communications in Bulgaria that resembles what we are talking about. The press release will make it clear to people more or less. They are most important to medical professionals. Recommendations have been made for patients on what should be alarming and not stay home and tolerate if exactly these things happen, and the idea is to reject them, and not confirm this rare effect, “added Dr. Popova.
“Data on more than 20 million cases have been analyzed, as both the UK and the US have looked at data from ongoing clinical trials that also do not detect such a relationship. The exposure is very serious in terms of the amount of vaccinated people, so the analysis shows that even within such a large number of the general population, that is, people who have not been vaccinated, these cases can occur, “said Bogdan Kirilov, explaining that a direct connection between the vaccine and these cases.
We have 100,000 AstraZeneca vaccines in stock and expect another 180,000 soon.
