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PubMedDate not supplied

The complicated task of monitoring vaccine safety.

Vaccination is an essential component of modern public health programs and is among our most cost-effective medical interventions. Yet despite vaccines' clear effectiveness in reducing risks of diseases that previously attacked large proportions of the population, caused many deaths, and left many people with permanent disabilities, current vaccination policies are not without controversy. Vaccines, like all other pharmaceutical products, are not entirely risk-free; while most known side effects are minor and self-limited, some vaccines have been associated with very rare but serious adverse effects. Because such rare effects are often not evident until vaccines come into widespread use, the Federal government maintains ongoing surveillance programs to monitor vaccine safety. The interpretation of data from such programs is complex and is associated with substantial uncertainty. A continual effort to monitor these data effectively and to develop more precise ways of assessing risks of vaccines is necessary to ensure public confidence in immunization programs.

Adverse Drug Reaction Reporting Systems↗
PubMed1982

BCG vaccine-induced lupus vulgaris.

A case of intradermal BCG vaccination was complicated by a lupus-like tuberculosis cutis progressive for over 30 years. The patient had been vaccinated twice with BCG in the affected site. A review of other BCG vaccine-induced cases of lupus vulgaris indicates that the incidence of this complication is markedly increased following multiple BCG vaccinations, but is rare following a single BCG vaccination. In our patient a skin biopsy specimen was characteristic for lupus vulgaris. Acid-fast stains from the tissue and cultures from the affected site were negative. The patient was successfully treated with rifampin.

Adult↗
PubMed2003

Conventional influenza vaccination is not associated with complications in working-age patients with asthma or chronic obstructive pulmonary disease.

By using a nested case-control design, the authors studied the effectiveness of the influenza vaccine in reducing severe and fatal complications in 4,241 and 5,966 primary care, working-age patients aged 18-64 years who had asthma or chronic obstructive pulmonary disease during the 1998-1999 and 1999-2000 influenza epidemics in the Netherlands. Patients developing fatal or nonfatal exacerbations of lung disease, pneumonia, congestive heart failure, or myocardial infarction during either epidemic were considered cases. For each case, four age- and sex-matched controls were randomly sampled, and patient records were reviewed. Conditional logistic regression and propensity scores were used to assess vaccine effectiveness after adjustment for confounding factors. In seasons one and two, respectively, 87% (47/54) and 85% (171/202) of the cases and 74% (155/210) and 75% (575/766) of the controls had been vaccinated. After adjustments, vaccination was not associated with reductions in complications (season one: odds ratio = 0.95, 95% confidence interval (CI): 0.26, 3.48; season two: odds ratio = 1.07, 95% CI: 0.59, 1.96; pooled odds ratio = 1.07, 95% CI: 0.63, 1.80). Because influenza vaccination appeared not to be associated with a clinically relevant reduction in severe morbidity, other measures need to be explored.

Adolescent↗