BCG (tuberculosis) vaccine: who gets it, trials, surveillance, and sources

1. Basic Information

Disease Overview

• Tuberculosis (TB): Infection caused by Mycobacterium tuberculosis, spread by airborne droplets. Most infections are latent and asymptomatic; active pulmonary TB causes cough, fever, weight loss, and is fatal if untreated in a substantial share of cases. WHO estimates TB remains one of the leading infectious causes of death worldwide, concentrated in South and Southeast Asia, sub-Saharan Africa, and the Western Pacific.
• Severe childhood forms: Infants and young children are disproportionately at risk of TB meningitis and miliary (disseminated) TB — the forms BCG protects against most consistently and the main reason WHO recommends it at birth in high-burden settings.

Vaccine Overview

Source: WHO BCG vaccines position paper (2018); CDC/ACIP TB vaccination guidance.

Recommended For

• Infants in countries with high TB incidence — WHO recommends a single dose as soon as possible after birth as part of the routine national schedule.
• Not part of the general U.S. population's routine schedule. In the U.S., TICE BCG for TB prophylaxis is reserved for narrowly defined high-risk groups: e.g., TST/IGRA-negative infants who cannot be separated from a household member with infectious, inadequately treated TB, or who cannot receive long-term isoniazid prophylaxis; and selected healthcare or laboratory workers with ongoing exposure to drug-resistant TB strains, after individualized risk assessment.
• TICE BCG's other, unrelated FDA indication is intravesical immunotherapy for bladder carcinoma in situ — a cancer treatment use, not a vaccination, and outside the scope of this page's side-effect data.

2. International Schedule Comparison

BCG appears in the routine schedule of 18 of the 31 countries in this site's national-schedule dataset — more countries than all but a handful of other vaccines. Every entry below is a single universal dose at or near birth; none record a routine booster.

Source: this site's national immunization schedule dataset, compiled per-country from the cited national authority. Japan's later timing (5–8 months rather than at birth) reflects its specific national schedule. The remaining 13 countries in the dataset (including the United States, Canada, the United Kingdom, Germany, and most of Western Europe) do not include BCG in their routine universal schedule — most stopped universal BCG decades ago as TB incidence fell, switching to risk-based or no BCG policy.

3. Post-Licensure Pharmacovigilance Data

Not searched on this site. This site's live-scraped VAERS, Canada Vigilance, JADER, EudraVigilance, VigiAccess, and Lareb panels (used on the 20 routine-schedule vaccine pages) have not yet been run against BCG-specific product and search terms. U.S. VAERS volume for BCG is expected to be small in absolute terms, since BCG is given to very few people in the U.S. (narrow high-risk groups and bladder-cancer patients, not the general population) — but that has not been verified against the actual VAERS extract, so no count is published here.

4. Documented Adverse Events — Evidence of Association

BCG has one of the longest continuous safety track records of any vaccine still in use (first given to humans in 1921). The reactions below are drawn from WHO's position paper and GACVS reviews, not from this site's own VAERS pipeline (see Section 3).

Expected local reaction (not an adverse event)

Correct intradermal administration produces a small papule that typically ulcerates and then heals into a permanent scar over roughly 6–12 weeks. This is the intended, expected course of a correctly given dose and is used in some settings as informal confirmation of correct technique — it is not counted as a complication.

▶ Strong Evidence of Causal Association

• Regional (usually ipsilateral axillary) lymphadenitis: A recognized reaction, most often self-limited and resolving without treatment over weeks to months. Strong
• Suppurative (draining) lymphadenitis / local abscess: Less common than simple lymphadenitis; associated in some studies with higher-dose or technique factors (subcutaneous rather than strictly intradermal injection). Strong

▶ Moderate Evidence, Rare Events

• BCG osteitis / osteomyelitis: A rare complication, historically reported at varying rates across different BCG sub-strains and vaccination programs (notably studied in Scandinavian and Scottish post-marketing data in the 1990s–2000s), prompting ongoing strain- and dose-specific safety monitoring. Moderate

▶ Rare but Serious, Mechanistically Clear

• Disseminated BCG disease (“BCGitis”): A rare but serious and sometimes fatal complication, occurring almost exclusively in infants with an undiagnosed primary immunodeficiency (most notably severe combined immunodeficiency, SCID) or advanced HIV infection at the time of vaccination. Because BCG is a live vaccine, a child who cannot control a live mycobacterial infection can develop disseminated disease. This is the central reason WHO guidance addresses HIV-exposure status and why some national programs have adjusted birth-dose policy for infants with known HIV exposure. Strong (mechanism well understood; population risk is concentrated in a well-defined immunocompromised subgroup, not the general vaccinated population)

5. Efficacy & Effectiveness

BCG's efficacy against pulmonary TB in adults is unusually variable across trials — one of the most studied and debated efficacy patterns in vaccinology. Protection against severe disseminated childhood TB is far more consistent.

Source: WHO BCG vaccines position paper (Wkly Epidemiol Rec, 2018); Colditz GA, et al. Efficacy of BCG vaccine in the prevention of tuberculosis. JAMA. 1994;271(9):698–702; Mangtani P, et al. Protection by BCG vaccine against tuberculosis: a systematic review of randomized controlled trials. Clin Infect Dis. 2014;58(4):470–480.

6. Evidence Summary

BCG has a well-characterized safety profile built on over a century of international use. Local reactions and regional lymphadenitis are common and expected; serious disseminated disease is rare and concentrated almost entirely in infants with undiagnosed severe immunodeficiency, which is why screening for HIV exposure and other risk factors matters more than a population-wide safety concern. Efficacy against the severe childhood forms of TB is strong and consistent; efficacy against adult pulmonary TB is genuinely variable across settings, which is an active area of TB-vaccine research (including next-generation candidates intended to improve on BCG). In the U.S., where TB incidence is low, this risk-benefit balance is judged not to favor routine use — which is a policy decision based on local disease burden, not a statement that BCG is unsafe.

7. Vaccine Injury Compensation

BCG is not listed on the VICP Vaccine Injury Table (42 CFR §100.3), which covers vaccines recommended for routine administration to children or pregnant women in the U.S. Because BCG is not part of that routine U.S. schedule, a BCG-related injury claim would not be eligible for VICP's no-fault administrative compensation process. See this site's VICP / CICP compensation tables for the full list of covered vaccines and what the Table does and does not include.

8. Risk-Benefit Context & Limitations

• Why policy differs by country: The risk-benefit calculation for universal BCG depends heavily on local TB incidence. High-burden countries judge the (small, well-characterized) risk of local reactions and rare serious events in a tiny immunocompromised subgroup to be outweighed by strong protection against severe childhood TB. Low-incidence countries, including the U.S. and most of Western Europe, judge the reverse.
• TST interference: BCG vaccination can cause a false-positive tuberculin skin test (TST/PPD) for years afterward, complicating TB screening in vaccinated individuals who later move to or are screened in the U.S. Interferon-gamma release assays (IGRAs, e.g. QuantiFERON-TB) are not affected by prior BCG and are preferred for screening in BCG-vaccinated people.
• Surveillance blind spot on this site: As stated in Section 3, this page does not yet carry a live-scraped pharmacovigilance breakdown for BCG. That is a known gap in this site's data, not a claim that no such data exists elsewhere (WHO's VigiBase, which VigiAccess queries, does carry BCG reports globally).
• Next-generation research: Because of BCG's variable adult efficacy, multiple next-generation TB vaccine candidates (including revaccination strategies and new adjuvanted subunit vaccines such as M72/AS01E) are in active clinical development as of this page's last review, aiming to improve on or replace BCG for adolescent/adult protection. This page does not track that pipeline in detail.

9. Key References

1. World Health Organization. BCG vaccines: WHO position paper. Wkly Epidemiol Rec. 2018;93(8):73–96.
2. Colditz GA, Brewer TF, Berkey CS, et al. Efficacy of BCG vaccine in the prevention of tuberculosis: meta-analysis of the published literature. JAMA. 1994;271(9):698–702.
3. Mangtani P, Abubakar I, Ariti C, et al. Protection by BCG vaccine against tuberculosis: a systematic review of randomized controlled trials. Clin Infect Dis. 2014;58(4):470–480.
4. CDC. TICE BCG prescribing information and ACIP guidance on BCG use in the United States. fda.gov/vaccines-blood-biologics/vaccines/tice-bcg
5. WHO Global Advisory Committee on Vaccine Safety (GACVS) — statements on BCG and disseminated BCG disease in immunocompromised infants.

This page does not cite site-generated VAERS/VigiAccess/Lareb counts (see Section 3). Corrections and source improvements are welcome via OSMF contact.