The Drugs Controller General of India nearly automatically accepts drugs and vaccines approved by the EMA. The procedures undertaken by the EMA to evaluate the manufacturer's claims in the PSUR need to be reviewed. The manufacturer must explain the figures that have been submitted to the regulatory authorities. The number of observed deaths soon after vaccination among children older than one year was significantly higher than that expected by chance once the deleted deaths were restored and included in the analysis. GSK obtained the updated registration certificates for vaccine Infanrix Hexa for simultaneous prevention of 6 (six) infections and vaccine Synflorix for. It is apparent that the deaths acknowledged in the PSUR 16 were deleted from the PSUR 19. We analysed the data provided in the PSURs. This commentary focuses on that aspect of the PSUR which has a bearing on policy decisions. Each PSUR contains an analysis of observed/expected sudden deaths, which shows that the number of observed deaths soon after immunisation is lower than that expected by chance.
#Infanrix hexa 6 vaccine update#
The manufacturer, GlaxoSmithKline (GSK), submits confidential periodic safety update reports (PSURs) on Infanrix hexa to the European Medicines Agency (EMA). There have been a number of spontaneous reports of sudden unexpected death soon after the administration of Infanrix hexa (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenza type B vaccine).
0 kommentar(er)
