Your report to the Minister of Health
cc: [UNICEF, GACVS, UMC, Klinigen];
I am writing to inform you of a cluster of reactions that we have seen in Karoomana and Weston provinces, associated with the delivery of the Measles vaccination programme to preschool children, and specifically with Batch of the Klinigen vaccine. Since March we have identified 12 serious reactions and fatalities. In each case the children developed convulsions and fever within 48 hours of receiving the immunization. Two were hospitalized before they died and we have obtained one post mortem report confirming . In addition, a thorough check of scientific information available has been made, including seeking information available from and useful information from accredited websites listed at on measles vaccination.
I have also consulted with on the Reganda AEFI review committee, who has confirmed an incidence of serious AEFIs per million immunizations, which exceeds the rate seen in provinces using different batches of the vaccine. Our investigations have excluded programme error and coincidental events. We concluded that there is a specific problem restricted to the aforementioned particular batch of vaccine. I have therefore contacted , requesting the halting of the use of this batch immediately.
I have also reported the problem to the manufacturer, Klinigen and the procurement agency . Klinigen have tested reserve vials of the batch held at their laboratories. Their tests show that the batch of vaccine . They have consequently decided to issue an urgent recall on the batch. A full report on the events (symptoms and outcomes) will be submitted to the World Health Organization, in accordance with the international standards developed by the .
If you require any further information on this cluster of AEFIs, please do not hesitate to contact me directly.
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