Vaccines and biological medicines:

For several reasons, vaccines and biologicals require modified systems of safety monitoring. They are often administered to healthy children. This applies particularly to vaccines used within a national immunization programme. In many countries, those exposed to a particular vaccine represent the entire birth cohort and therefore a sizeable part of the entire population. People’s hopes of safety are high, and they are reluctant to countenance even a small risk of adverse events. Disquiets regarding vaccine safety, real or imagined, may result in loss of confidence in entire vaccine programmes. This can result in poor compliance and a consequent resurgence in morbidity and mortality of vaccine-preventable disease. It is essential that there should be adequate safety investigation supporting immunization programmes. The skills and organization to deal with genuine adverse events are essential in preventing or managing misplaced fear caused by false or unproven signals from patients and health workers that might adversely affect immunization cover. For example, concerns about the safety of whole-cell Pertussis resulted in dramatic reductions in vaccines coverage and a resurgence of Pertussis in many countries.

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    Vaccines and biological medicines: Conference Speakers

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