Vaccine adverse events in the new millennium: is the sky really falling?

ABSTRACT

PIP Brian Ward's article regarding immunization safety has caused experts with long immunization experience to dismiss the paper out of hand as alarmist. Some of the reasons for this include the following 1) lack of context or balance; 2) presentation of an indiscriminate and unlabelled mixture of conjecture, speculation, hypothesis and fact; 3) the plea for essentially unlimited resources to study vaccine safety issues; and 4) the inclusion of societal or indirect costs in economic analyses. However, the author states that the significant negative features of Ward's paper should not overshadow key issues in vaccine safety and vaccine adverse events mentioned in the paper. These include the following 1) novel approaches to vaccine composition or presentation and new combinations of vaccines raise additional possibilities for adverse events; 2) state-of-the-art technology must continue to be applied to studies of vaccine safety as the technologies develop; 3) more resources need to be devoted to studies of vaccine safety; 4) industrialized countries will have to bear the primary burden of these studies as they are beyond the resources of most developing countries; 5) communication to the public about risks and benefits of vaccines is both essential and complex; and 6) open discussion in the scientific community about vaccine adverse events is essential but needs to be conducted in a way that neither unduly alarms people nor appears to minimize the issues.^ieng