Nøkleby Hanne, Bergsaker Marianne A Riise
Divisjon for smittevern, Nasjonalt folkehelseinstitutt, Oslo, Norway.
Tidsskr Nor Laegeforen. 2006 Oct 5;126(19):2541-4.
When the diseases we try to prevent through vaccination are rare, we tend to focus more on the associated risks. Vaccination has led to unfortunate consequences, mainly due to production failure and inadequate control in earlier years. The requirements for vaccine control are now so rigorous that the risk for such occurrences is close to zero. Local and mild systemic reactions to vaccines are rather common, and are usually well known and described in detail when a vaccine is licensed. Some vaccine reactions are however so rare that they only will be discovered through surveillance after the vaccine has become available for routine use. Suspicion of adverse events will now normally arise through the official notification systems for adverse events. Large epidemiological studies are often necessary to decide whether there is a causal relationship or only a coincidence. Recording of adverse events following vaccination and transparency about their existence, are important issues in the work to maintain the credibility of vaccines.
当我们试图通过接种疫苗预防的疾病很罕见时,我们往往会更关注其相关风险。疫苗接种曾导致过不幸后果,主要是由于早年生产失败和管控不足。如今对疫苗管控的要求极为严格,此类情况发生的风险已接近零。疫苗的局部和轻度全身反应相当常见,在疫苗获批许可时通常就已广为人知且有详细描述。然而,有些疫苗反应极为罕见,只有在疫苗投入常规使用后通过监测才能发现。现在,对不良事件的怀疑通常会通过官方不良事件通报系统出现。往往需要进行大规模流行病学研究来判定是存在因果关系还是仅仅是巧合。记录疫苗接种后的不良事件并公开其存在情况,是维护疫苗可信度工作中的重要问题。