Presenting the case for an immunization safety surveillance system.

Brian Ward is to be congratulated on stating so clearly the reasons for a monitoring system being necessary for any adverse events that could be related to vaccination (1). I believe the reticence of governments about inaugurating surveillance systems has several causes. First, although WHO encourages its Member States to develop and sustain a monitoring system, they still do not see the need for such a system or the value of it very clearly. Second, health departments are concerned that systematic searching for adverse events related to vaccination might have a negative impact on their immunization programmes, by giving the impression to immunization teams that the vaccines are not safe, contrary to what they had learnt during training. In addition, asking questions in the community might prompt people to think that something wrong with the vaccines, concealed from the users, is the reason for data being collected, even though the vaccines have been in use for a long time without the issue being raised. The importance of surveillance of adverse events following vaccination was not widely recognized in Egypt until April 1998 when a few adverse events occurred in one governorate and were considered to be vaccine-related. The media received information about these cases before the medical authorities did, as at that time there was no surveillance system for such occurrences. Irresponsible handling by the media caused rumours to spread that the vaccine was unsafe. This tarnished the reputation of the immunization programme, led to community panic, and had a negative effect on the coverage for all seven antigens included in Expanded Programme on Immunization (EPI) activities all over the country. After that, the Ministry of Health decided to establish a comprehensive system for the surveillance of adverse events following vaccination aimed at detecting such events early so that they could be investigated and proper action could be taken. The system was established with a central surveillance officer assigned to work closely with the national regulatory authority. Surveillance officers were assigned within the immunization programme in each governorate to maintain a regular reporting system and ensure that the health department could move immediately and appropriately whenever a report made it necessary. In addition, health staff at various levels were given special training in signs and symptoms to look out for. Seven serious events and many minor ones were discovered through this surveillance system between July 1998 and September 1999. No problems were encountered, and the situation was controlled and contained without any negative impact. There was a rapid response to the need for investigation and management of cases, and for satisfying the local community and parents that proper care was being taken. Our experience in Egypt indicates the importance of having a comprehensive system for surveillance of adverse events following immunization, and I should like to encourage other countries to go ahead with similar plans. The reservations I enumerated in my first paragraph have proved unfounded, and even people who were initially sceptical have seen the value of our activities. Nevertheless, I would like to propose a change in the terminology. The term ‘‘Immunization Safety Surveillance System’’ would be more suitable and positive, as ‘‘adverse events’’ has negative connotations especially when translated into some other languages, such as Arabic. n