AIMS: In 1936 the Finnish Anti-Tuberculosis Association founded the first nursery, "Joulumerkkikoti", into which infants born into tuberculous families were admitted and given BCG vaccination to reduce the risk of tuberculosis. This prophylactic regimen was effective in reducing infant mortality and morbidity of tuberculosis. We investigated the mortality of these children later in childhood and adulthood. METHODS: The index cohort consisted of 3,020 subjects born between 1945 and 1965 in Finland and isolated from their family immediately after birth. The average separation time was 218 days. The subjects alive on 1 January 1971 were identified. For every index subject two reference subjects were chosen, the matching criteria being sex, year, and place of birth. Data on causes of deaths were obtained from the Finnish Cause of Death Registry by the end of 1998. RESULTS: The relative mortality rate (RR) was higher in the index cohort than in the reference cohort for all causes of death (RR 1.4; 95% CI 1.2-1.7), and particularly for unnatural deaths: RR 1.5 (1.1-1.9) for men and RR 1.9 (1.0-3.7) for women. CONCLUSIONS: The mortality in the index subjects later in childhood and adulthood was somewhat elevated. This may be explained by a variety of risks experienced during pregnancy, delivery, and childhood. The fall in the socioeconomic status of the family of origin due to tuberculosis may partially explain the result. Another interpretation is that the very early separation from the mother had unfavourable effects on later psychological developments in some children.
The BCG vaccine is currently the only approved tuberculosis vaccine and is widely administered worldwide, usually during infancy. Previous studies found increased rates of lymphoma and leukemia in BCG-vaccinated populations.
To determine whether BCG vaccination was associated with cancer rates in a secondary analysis of a BCG vaccine trial.
Retrospective review (60-year follow-up) of a clinical trial in which participants were assigned to the vaccine group by systematic stratification by school district, age, and sex, then randomized by alternation. The original study was conducted at 9 sites in 5 US states between December 1935 and December 1998. Participants were 2963 American Indian and Alaska Native schoolchildren younger than 20 years with no evidence of previous tuberculosis infection. Statistical analysis was conducted between August 2018 and July 2019.
Single intradermal injection of either BCG vaccine or saline placebo.
The primary outcome was diagnosis of cancer after BCG vaccination. Data on participant interval health and risk factors, including smoking, tuberculosis infection, isoniazid use, and other basic demographic information, were also collected.
A total of 2963 participants, including 1540 in the BCG vaccine group and 1423 in the placebo group, remained after exclusions. Vaccination occurred at a median (interquartile range) age of 8 (5-11) years; 805 participants (52%) in the BCG group and 710 (50%) in the placebo group were female. At the time of follow-up, 97 participants (7%) in the placebo group and 106 participants (7%) in the BCG vaccine group could not be located; total mortality was 633 participants (44%) in the placebo group and 632 participants (41%) in the BCG group. The overall rate of cancer diagnosis was not significantly different in BCG vaccine vs placebo recipients (hazard ratio, 0.82; 95% CI, 0.66-1.02), including for lymphoma and leukemia. The rate of lung cancer was significantly lower in BCG vs placebo recipients (18.2 vs 45.4 cases per 100?000 person-years; hazard ratio, 0.38; 95% CI, 0.20-0.74; P?=?.005), controlling for sex, region, alcohol overuse, smoking, and tuberculosis.
Childhood BCG vaccination was associated with a lower risk of lung cancer development in American Indian and Alaska Native populations. This finding has potentially important health implications given the high mortality rate associated with lung cancer and the availability of low-cost BCG vaccines.
The incidence of BCG ostitis was studied by the data of questionnaires sent from 36 areas of the Russian Federation (RF). Particular emphasis is laid on 15 northwestern RF regions where an indepth study dealing with the 2000-2004 detection rates of postvaccination osseous complications was conducted. The mean incidence rate was 6.62 per 100,000 vaccinated persons with great data differences between the regions. The reasons for the detected differences and the perspectives of further studies of the epidemiological indices of the incidence of postvaccination osseous complications are analyzed.