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The Investigative Committee has completed examination due to the death of two-month-old child in Gantsevichy District

The Investigative Committee has completed examination due to the death of two-month-old child after carrying out of scheduled vaccination. This case has happened in Gantsevichy District in August, 2018. Examination process was controlled individually by the Chairman of the Investigative Committee Ivan Noskevich. 

It was established that prior to the tragedy the child underwent health checks by the doctor. No disease states, abnormalities, as well as any hypersensitivity reactions were present or detected. Pursuant to information, mentioned in medical documents, and according to the results of physical examination there was no opportunity to foresee the occurrence of hypersensitivity reaction prior vaccine administration. Pathological process, led to the critical condition, was in rapid and unpredictable progress.

Meanwhile the special commission of the Ministry of Healthcare of the Republic of Belarus has established the number of violation of official enactments with regard to maintenance of medical documentation by the employees, as well as compliance with vaccination procedures with regard to informing of parents about possible adverse affects after vaccine administration. Disciplinary actions were taken against such employees. 

However, identified deficiencies have no causal connection to the death of the child. No violations, related directly to the tactics or mechanism of vaccine administration were established as well. Imovax Polio and Eupenta vaccines, given to the child, were allowed for use by the Ministry of Healthcare of the Republic of Belarus for the moment of vaccination. 

Pursuant to the conclusion of commission comprehensive judicial, medical, pharmacological and chemical expert examination, the cause of child’s death was multiple organ system failure, caused by severe anaphylactic reaction of immediate type (anaphylactic shock) to adequately prescribed and correctly administered Imovax Polio and Eupenta vaccines. 

Having regard to the above, the investigation agencies came to the conclusion on the absence of the event of crimes, prescribed by the clauses “Medical misconduct”  and “Neglect of duty” in the actions of officials and medical officers. Alongside this, the investigators have carried out comprehensive study of circumstances of the procurement of medical preparation Eupenta and the quality of vaccine. 

The violations of procurement procedure, related to imperfections of legislation, and motivated by objective necessity of procurement of large amount of vaccine in the shortest time possible, are established in a process of examination. Herewith no causal connection between the actions of health authorities and health care facilities regarding examination, certification, testing and taking into use of Imovax Polio and Eupenta vaccines with child’s death coming is established. No violations of storage requirements, receipt, dispensing and administration of drugs are detected. 

The investigators also examined documentations, confirming the quality of Eupenta vaccine: including, mill test certificates of preparation from Southern Korea and certificate, issued for importing country. 

The immunization with Eupenta vaccine is ongoing in Belarus at the moment. Moreover, in period from January till August, 2018 about 100 thousand Eupenta vaccinations were made, and adverse reactions are registered only in two cases. The number of similar reactions after administration of other previously used vaccine was several times as much in average.

Pursuant to the examination of the Investigative Committee, the presentation to the Ministry of Healthcare with the proposals of initiating of alterations to the legislation with regard to the procurement of medical preparations is prepared. 

Information and Public Relations Department