„In Bulgaria there is no case of a proven causal link between the vaccine against COVID 19 and death. The Executive Agency for Medicines (BDA) is the institution in our country that monitors for post-vaccine side effects, and a call for reporting them after the vaccine has been published on the agency’s website.“
This was announced by the Ministry of Health and the BDA after journalistic questions related to the allegations of Assoc. Prof. Atanas Mangarov: „564 people who died died because they were vaccinated“. The department also informs:
„The number of reports made since the beginning of the vaccination campaign in Bulgaria so far for a suspected link between death and vaccination against COVID 19 is a total of 9, and in none of the cases has this been proven. In the last 14 days alone, 93.12% of the citizens who died of COVID-19 have not been vaccinated.
The BDA also reported a total of 6 deaths from COVID-19 disease, with infection occurring between the two doses of vaccine, and in one case the disease was detected on the day the vaccine was administered.
As of January 17, 2022, the total number of reported adverse reactions to the BDA after administration of vaccines against COVID-19 is 3861. Among them, about 10% are reactions that meet the criteria for severity. Whether the medical significance of the observed reaction is determined to be serious is assessed after a thorough analysis.
According to the current requirements, a serious adverse drug reaction is any adverse effect on the health of a person who has caused immediate danger to life; hospitalization or extension of the term of hospitalization; significant or permanent damage; disability; congenital anomalies, other reactions of medical significance.
Vaccine safety monitoring is based on a review of all available and verifiable information and the results of its analysis. All available data, as well as the phased assessment, are published regularly on the website of the licensing authority – the European Medicines Agency (EMA). The EMA’s website publishes including the total number of reports made and the number of reports of fatalities, together with the explanation that this is information about a suspected link to a medical event observed after the use of a vaccine. The fact that a person has experienced such a medical event or fatal outcome after vaccination does not necessarily mean that it is related to the vaccine, as the latter is subject to certification and proof.
The Executive Agency for Medicines shall encourage in every way possible the reporting of suspected adverse reactions. A call for notification is contained in each leaflet of each medicinal product, as well as in the information for medical professionals, called the summary of product characteristics.“
