The geographic distribution of vaccine recipients in the study sample was related to the distribution of BCG providers rather than to regional population size. The cumulative incidence of adverse reactions for the 2 age groups was calculated. Concomitant vaccinations (those given within 4 weeks before BCG vaccination) were administered to 292 vaccinees (32%). Some strains are known to be more potent (reactogenic) than others [10, 10].

None required treatment. Certain characteristics of the recently introduced BCG (Connaught) vaccine may have accounted for a proportion of adverse reactions. Injection-site abscesses (RR, 2.96; 95% CI, 1.11–7.90) and severe local reactions (RR, 4.93; 95% CI, 1.11–21.90) were significantly more common in older vaccinees. Deidentified data for all enrolled vaccinees were forwarded for entry and analysis. None was recorded as having a positive test result (⩾5 mm). Factors associated with the development of adverse reactions and their management. Case identification.

Of these, 234 were infants receiving routine childhood immunizations (predominantly hepatitis B vaccine [94%] but, also, diphtheria-tetanus-pertussis and oral polio vaccine). The vaccine batch associated with the earlier regional cluster of adverse events [6] was not distributed during the study.

There were no reports of disseminated BCG infection.

Although the overall male:female ratio for adult vaccinees was 1.7:1 (table 1), for Defence Force personnel, the ratio was 3:1. The vaccine is recommended to be given via intradermal injection (Connaught product information, distributed by CSL, Melbourne, Australia). Standard data collection forms were used. A sample size of 900 vaccinees was calculated to be necessary to achieve a precision of ±2.5% around an expected adverse reaction incidence of 3% with 95% confidence. Top of page

In Australia, childhood BCG vaccination was discontinued in the 1980s, and vaccination is currently recommended only for those individuals at high risk of exposure to tuberculosis, including Aboriginal or Torres Strait Islander neonates living in regions of high incidence; children aged <5 years who will be traveling to live in countries with a high tuberculosis prevalence or who live in households with migrants or visitors from countries with a high incidence of the disease; health care workers in certain occupational areas; and travelers aged >5 years who will spend prolonged periods in countries with a high prevalence of tuberculosis [4]. Types of reactions reported were as follows: local and other (n = 3), abscess and local (n = 4), and abscess and other (n = 1).

Because we followed the vaccinees for 18 weeks, it is unlikely that adverse reactions were underestimated; however, several factors may have led to the overestimation of reactions.

It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Eleven vaccinees (1%) required attention from a health care practitioner (table 2). Similar findings have been reported in other countries [13].

Although current Australian guidelines recommend that vaccination be done by a trained provider, there is no universal training standard.

Cumulative incidence (%) of adverse reactions after BCG vaccination, by age group and type of reaction. The remaining 328 vaccinees could not be contacted for follow-up. Reactions, particularly lymphadenitis, were significantly less common in infants <6 months old (but not in subjects aged ⩾6 months) vaccinated by trained (vs. untrained) providers (relative risk [RR], 0.24; 95% confidence interval [CI], 0.09–0.68). Adverse reaction rates were higher overall for older people compared with infants. Another 6 problems categorized as “other” were reported: pronounced scars (n = 3), marked redness at the site of injection within 24 h of vaccination (n = 2), and fever for 2 days after vaccination (n = 1). Adverse reactions were less common among older subjects when a previous tuberculin skin test had been performed (RR, 0.27; 95% CI, 0.09–0.77). BCG was first introduced into the NHS’ childhood vaccination scheme in 1953, and until 2005 the vaccine was administered to all children at the age of 13. Please check for further notifications by email.

Of the 504 vaccinees for whom a tuberculin test was indicated (individuals aged ⩾6 months), 489 (97%) were tested before vaccination.

To compare the groups, RRs and their 95% CIs were determined for each reaction type, and Fisher's exact test was used to ascertain whether the relative risks were significant and to identify factors associated with an increased risk of adverse reactions. Respiratory, growth, and survival outcomes of infants with tracheostomy and ventilator dependence.

Australian Defence Force: Health Services Flight Combat Support Unit, Wagga, New SOuth Wales (NSW); Canberra Area Medical Unit, Duntroon, Australian Capital Territory; Royal Australian Air Force (RAAF) Base Edinburgh, South Australia Area Health Service; 302 Health Services Flight, RAAF Base Williamtown, NSW; No 6 RAAF Hospital, Base Williams, Laverton, Victoria; and 382 Health Services Flight, RAAF Base Amberley, Ipswich, Queensland; Health Centre Cerberus, Victoria.

In particular, BCG vaccines with lower numbers of culturable particles (and therefore lower ratios of live to killed bacilli), including Connaught, have been associated with an increased incidence of adenitis. Vaccinees were also encouraged to report any adverse reactions to their provider during this time. Providers' lack of experience in administration of the vaccine may also have contributed to an increased incidence of reactions.

The World Health Organization (WHO) currently recommends childhood BCG for all countries with a high incidence of TB and/or high leprosy burden. Assessment of Treatment Tolerance and Parental Perspective of Outpatient Pulsed-Dye Laser Treatment for Port-Wine Birthmark without General Anesthesia in Infants and Toddlers. Conversely, among those training in areas of health care, women outnumbered men (female:male ratio 1.5:1). The vaccine used during the study was the Connaught (Montreal strain) freeze-dried, live BCG vaccine.

Of the 503 adults for whom a vaccine dose was recorded, 96% received 0.1 mL; the remainder received either 0.05 mL or 0.075 mL. During November 1998-December 1999, 1246 vaccinees were enrolled in the study; 918 patients (74%) completed follow-up. The vaccine reduces the risks of invasive tuberculosis and death from tuberculosis by about 70%.

Year (month) Vaccine details … Most vaccinations (63%) were administered in hospital-based or Defence Force clinics (which are listed in the Acknowledgments).

Adverse reactions. BCG vaccination is still considered an important strategy in the National Tuberculosis Programs of countries with a high burden of tuberculosis (TB) because of its benefit to infants but its effect on the control of TB has been limited. Disseminated Bacille Calmette-Guérin Disease After Vaccination: Case Report and Review, Bacille Calmette-Guérin Vaccination for the Prevention of Tuberculosis in Health Care Workers. Neither age at vaccination (P = .61) nor birth weight (P = .54) were significant factors. In the current study, adverse reactions were identified by active surveillance that used standard case definitions [6]. Administering BCG vaccinations on a frequent basis centers in all Australian states or territories were invited to participate in the study.

Hospitals/chest clinics: Royal Adelaide Hospital, Queen Elizabeth Hospital, Lyell-McEwin Hospital, Liverpool Hospital, Parramatta Chest Clinic, Royal Prince Alfred Hospital, Perth Hospital, Broome Hospital, Launceston General Hospital, Royal Hobart Hospital, Risden Prison Hospital, Canberra Hospital, Mildura Hospital, Royal Darwin Hospital, and Katherine Hospital. In particular, an earlier regional study's suggestion of a significant increase (from 0.7% to 3%) in adverse reactions after introduction of the Connaught vaccine could not be examined because the previous (CSL) vaccine was no longer in use [6] .

Connaught batch 2615-13 accounted for 90% of the BCG vaccine distributed in Australia in 1998.

Active surveillance of adverse events after vaccination is not conducted routinely in Australia but has been previously conducted in specific instances, such as the 1998 Measles Control Campaign [22]. The median time to onset was 30 days (range, 4–65 days).

Most adverse reactions were mild and self-limiting. Continuous variables were analyzed by analysis of variance. National Health and Medical Research Council. Vaccination skills are more likely to be maintained when the vaccine is given on a regular basis. Despite its modest efficacy [1, 2], the vaccine has been used in >80% of the world's population [3]. The BCG vaccine: information and recommendations for use in Australia(March 2006) has been updated to incorporate the most recent trends in annual national tuberculosis (TB) surveillance data. Vaccinees were stratified by age into 2 groups for analysis: those aged <6 months and those aged ⩾6 months. Among the 414 infants aged <6 months, 74% were neonates (<28 days old), and 90% were Aboriginal or Asian (table 1).

Vaccine batch was documented for 99.6% of subjects. Although there was no difference in the overall incidence of reactions according to sex, (10 [83%]) of 12 older vaccinees who reported local reactions were women (RR, 7.18; 95% CI, 1.59–32.45). Table 1: Vaccine history in Australia, 1804 to current time. The current passive Australian surveillance system for adverse events (Adverse Drug Reactions Advisory Committee, or ADRAC) identified only 20 BCG adverse reactions during the period of our study (ADRAC, unpublished data).

We thank the BCG vaccination providers who contributed data for this study (see below). Study population. Vaccinees received 1 of 4 vaccine batches: 2612-12 (26 vaccinees), 2614-12 (69 vaccinees), 2615-13 (807 vaccinees), and 2616-14 (13 vaccinees). We would also like to thank squadron leader Anne-Marie Pope, Susan Botham, Geraldine Smith, AnneMarie Egan, Barbara Clifton-Smith, Marysia Carr, Jill Forrest, CSL Vaccines, the Therapeutic Goods Administration, University of Sydney Student Health Service, and the ADRAC. These local complications after BCG vaccination highlight the need for careful consideration of the indication for vaccination (including interpretation of tuberculin skin test results) and clear explanation of possible side effects [17]. This is particularly important for neonatal vaccination, for which there is an increased risk of inadvertent subcutaneous injection.

However, this was most pronounced in infants aged <6 months, 24% of whom were vaccinated by untrained staff.

No reaction caused swelling beyond the nearest joint or resulted in hospitalization. Local reactions were more frequently reported by adult females than by adult males (RR, 7.18; 95% CI, 1.59–32.45). Adverse reactions were detected by active case patient-finding by health care providers (by telephone or in a face-to-face interview) at 2–4 weeks and again at 16–18 weeks after vaccination. Experts now believe the Bacillus Calmette Guerin (BCG) jab is ineffective, only protecting three-quarters of those vaccinated against TB. The smaller size of the study and the higher vaccine dose, relative to weight, for most female subjects may be important; some studies have suggested that female vaccinees find the local reaction to BCG cosmetically unacceptable [16].

Despite its modest efficacy [1, 2], the vaccine has been used in >80% of the world's population [].In Australia, childhood BCG vaccination was discontinued in the 1980s, and vaccination is currently recommended only for those individuals at high risk of exposure to tuberculosis, including Aboriginal …