There is no medical relation between the haemolytic-uremic syndrome (HUS) diagnostic in the case of transferred infants with serious health conditions from the Pitesti Paediatric Hospital to the Marie Curie Hospital of Bucharest, says the Health Ministry.
The ministry’s statement comes as an inquiry into HUS-diagnosed children by the control team of the prime minister revealed the use of unauthorised vaccines.
“Specialist medical literature says cases of haemolytic-uremic syndrome cases presumed to be related to vaccination are extremely rare. Over the past 15 years, their number has not exceeded 10 worldwide. Even in these presumed cases signs emerged within 14 days of the vaccination, and not within months since the last vaccination, as was the case with the Arges infants. Moreover, the presence of the enterohemorrhagic Escherichia coli detected in the Arges infants entails the ingestion of spoiled products and presence in the digestive tract. Consequently, the Health Ministry is satisfied that there is no relation between the Arges infant having fallen sick with the enterohemorrhagic Escherichia coli and vaccinations,” the ministry says in a press statement.
It argues that public associations of independent themes from a control report risk endanger vaccination campaigns needed to avoid the re-emergence of epidemics in Romania.
An inquiry conducted by the Prime Minister’s Control Team in the situation of children with serious health conditions transferred to the Marie Curie Hospital has revealed that October 17 – February 3, 2016, Polisano SRL delivered to Romanian public healthcare directorates 940,995 hexavalent vaccine vials, 11,800 of which were HEXACIMA-branded vaccine in Slovakian vials, 20.042 HEXACIMA-branded vaccine in Bulgarian vials and 107,300 HEXAXIM-branded vials for Kazakhstan, all under an agreement with the Health Ministry.
The inquiry reports that although the National Agency for Medicines and Medical Devices has informed the Health Ministry that the HEXAXIM-branded vaccine for Kazakhstan was not approved to be released to the Romanian market because it only had one positive scientific opinion from the European Medicines Agency, Polisano SRL was nonetheless authorised to distribute 107,300 vials of 0.5 ml each of HEXAXIM vaccine, conditional on some obligations.
Early this year, 24 cases of serious digestive conditions in infants were reported in Romania, particularly in Arges County, 19 of whom developed the haemolytic-uremic syndrome.
Eleven infants tested positive for the same O26 strain of the enterohemorrhagic Escherichia coli bacteria, which statistically is the most frequent cause of the HUS.
Gov’t Control Corps: Cause of Arges County illness outbreak not identified, system non-compliances discovered
The fact-finding investigation conducted by the Prime Minister’s Control Corps did not identify the cause for the illness outbreak among Arges County children, several of whom have been transferred, beginning this February, from the Pitesti Pediatric Hospital to the “Marie Curie” Children’s Emergency Hospital in Bucharest; however, several non-compliances in the health system emerged on this occasion, said the government.
“The Prime Minister’s Control Corps did not identify the cause of the illness of the children transferred from the Pitesti Pediatric Hospital to the ‘Marie Curie’ Children’s Emergency Hospital in Bucharest. However, the fact-finding investigation performed identified non-compliances in the health care system which were mentioned in the report drawn up at the end of the action. Nowhere does the report mention the existence of a connection between the non-compliances identified in the supply and management of the vaccine stocks and the condition of the children from the Pitesti Pediatric Hospital. Such a connection would actually be impossible from a medical viewpoint, and any speculation in this regard is groundless,” reads a government release to Agerpres.
The specifications come after the release this Wednesday of the report on the result of the fact-finding inquiry carried out by the Prime Minister’s Control Corps into the situation of the children transferred with serious conditions from the Pitesti Pediatric Hospital to the “Marie Curie” Children’s Emergency Hospital in Bucharest.