25.05.2016
To the attention of interested persons
Following appearance in the media of the Notification on the outcome of the verifications performed by the Prime Minister’s Inspectorate related to the condition of children suffering from the Hemolytic-uremic syndrome (HUS), the NAMMD preliminarily informs that:
The notice has been communicated to the press without discussing the matter with the NAMMD to scientifically substantiate the conclusions shown in the respective document.
Consequently, we regretfully realize that the public has not been informed adequately, since, given the lack of proof based on legislative substantiation, the notification contains several issues showing a misunderstanding of the underlying mechanisms of the marketing of the hexavalent vaccine (commercial name – HEXAXIM).
Right from the start, we would like to remind you that there is no proof establishing a direct and unquestionable link between the vaccination scheme and children diagnosed with HUS. Thus, the epidemiological method performed in this case does not establish any connection between vaccine administration and disease onset.
In order to reject any doubt about the legality of placing HEXAXIM on the Romanian market, as an EU member state, we hereby inform public opinion that Romania, through the NAMMD, has made sure that the authorisation if performed in line with the legal framework, this aspect also being officially confirmed by the European Medicines Agency (EMA). Moreover, in similar cases, other EU member states such as Belgium and Poland, having to face the lack on the market of the hexavalent vaccine (HEXACIMA), have resorted to the same solution: ensuring the national vaccination programme through authorisation of HEXAXIM, as a vaccine fully identical with the already existing vaccine, in the initial scheme (HEXACIMA/HEXYON).
The NAMMD assures the population and the empowered bodies upon its willingness to provide help with technical and scientific information proving that the regulatory authority in the field of the medicinal product has managed, once again, to attain its primary scope of protecting public health in an emergency situation requiring rapid measures, yet fully compliant with legal provisions in force.