Your report to the Minister of Health

Memo To: Professor John Urumono Dr Pasquale Ridou Dr Maia Rayon Dr Meeta Swahami Dr Ramon Cajal

cc: [UNICEF, GACVS, UMC, Klinigen];

Priority: Urgent

Dear Professor John Urumono Dr Pasquale Ridou Dr Maia Rayon Dr Meeta Swahami Dr Ramon Cajal ,

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 T-7104 T-7111 U-5773 U-5776 U-5889 of the Klinigen vaccine. Since March we have identified 12 serious reactions and 3 4 5 6 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 viral encephalitis c malaria encephalitis (no infection) viral meningitis cysticercosis (helminth infection) . In addition, a thorough check of scientific information available has been made, including seeking information available from the Ministry of Health Global Advisory Committee on Vaccine Safety UNICEF Klinigen and useful information from accredited websites listed at http://www.who-umc.org www.who.int/vaccine_safety/initiative/communication/network/vaccine_safety_websites www.who.int/vaccine_safety/topics brightoncollaboration.org/public on measles vaccination.

I have also consulted with Professor John Urumono Dr Pasquale Ridou Dr Maia Rayon Dr Meeta Swahami Dr Ramon Cajal on the Reganda AEFI review committee, who has confirmed an incidence of 10 50 100 200 500 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 regional health officers the national immunization programme the vaccine distributors , requesting the halting of the use of this batch immediately.

I have also reported the problem to the manufacturer, Klinigen and the procurement agency Yuchong Medical Supplies UNICEF the national reference laboratory . Klinigen have tested reserve vials of the batch held at their laboratories. Their tests show that the batch of vaccine is fully in accordance with specifications has undergone a reversion is contaminated with lipopolysaccharide . 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 Brighton Collaboration WHO Reganda AEFI review committee .

If you require any further information on this cluster of AEFIs, please do not hesitate to contact me directly.

Yours sincerely,