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POST 00469E : ADVERSE EVENTS FOLLOWING IMMUNIZATION 8 July 2002 ____________________________________________________________ Many of you may already be aware of an incident involving measles vaccination in Cuba, as reported in the media and Promed-Mail, the Program for Monitoring Emerging Diseases. According to reports, on 22 May 2002, an "uncommon accident" with imported vaccine dosages left 3 children dead and 42 others sick. The 3 children died after receiving injections from "apparently contaminated" vials filled with the anti-measles vaccine manufactured in India. Following this event, Cuba suspended its measles vaccination programme pending investigation. A Government communiqué published in the local media said the vaccines had been certified by and acquired through the World Health Organization. It provided no other details on Cuba's acquisition of the vaccines, nor where in Cuba the children had died. The World Health Organization is thus issuing the following statement. And those who would be interested in further information on adverse events following immunization can consult the following document : "Surveillance of adverse events following immunization: Field guide for managers of immunization programmes, WHO/EPI/TRAM/93.02 REV.1" The document can be accessed electronically from the site which gives documents in alphabetical order: http://www.who.int/vaccines-documents/DoxGen/H3DoxList.htm _____________________________________________________________________ WHO Statement on Measles Vaccine from Serum Institute of India (SII) Following the serious cases of adverse events following immunization with measles vaccine in Cuba, a thorough investigation of cases is taking place. PAHO/WHO is providing whatever assistance is required for this purpose, as follows: 1. Epidemiological investigation is still underway to understand in depth what has happened. One staff of PAHO's Division of Vaccines and Immunization is in Cuba working with the Cuban authorities in the analysis of the data. 2. Samples either from the vaccine or diluent have been collected in the field and were sent 24 June 2002 to WHO for quality control testing in reference laboratories. 3. PAHO has recommended that all countries of their Region keep using the measles and measles-rubella vaccine manufactured by SII in their routine immunization programmes or campaigns. In addition to this investigation, taking into account the fact that the measles vaccine used was supplied through the PAHO Revolving Fund and is thus a WHO-prequalified vaccine, WHO follows a standard protocol. Independently of whether the cases are shown to be vaccine related or not, in the case of occurrence of serious events such as these, WHO takes immediate action in investigating the quality of the relevant vaccine lots. In this case the steps taken have been the following: * Thorough review of production and control protocols * Submission of samples retained by the manufacturer for independent testing in two laboratories. This was done in the case of this vaccine from Serum Institute of India early in June 2002. * Submission of samples taken from the field for independent testing in two laboratories. This is being done as mentioned above. * A team is put together to make an audit of the manufacturing facilities in order to make a thorough investigation of the production and testing of the relevant batches. The team will also make a full review of any potential deviations from GMP. The team will be in India the first week of July. * Follow-up with other countries using the suspected products and/or lots. This has been done and a full analysis has been provided from Egypt, which has used the one of the implicated lots of the vaccine under full regulatory control without reported problems. Once all the information is analyzed, we will issue a full report. In the meantime, we continue to recommend that countries keep using the measles and measles-rubella vaccine manufactured by SII in their routine immunization programmes or campaigns. ----------------------------------------------------------------------------- ------------- CONTRIBUTIONS: Contributions to: or use your reply button! The TechNet21 e-Forum welcomes new subscribers who are involved in immunization services. SUBCRIBE: To subscribe, send an e-mail to: Leave the SUBJECT area BLANK, do not type anything. In the body text, just write: Subscribe TECHNET21E Surname Name Do not use any accents in your name and surname. UNSUBSCRIBE: To unsubscribe, send an e-mail to: Leave the SUBJECT area BLANK, do not type anything. 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