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Efficacy
The world's largest (and only double-blind) vaccine trial of BCG vaccine was conducted in India. The India study showed that incidence of TB was higher in the vaccinated group than in the control (unvaccinated) group.
The New Scientist wrote: “The world's biggest trial to assess the value of BCG tuberculosis vaccine has made the startling revelation that the vaccine does not give any protection against bacillary forms of tuberculosis.”
The Lancet (14 March 1992) also carried out a study of 83,000 people who had been vaccinated against TB and concluded that they could find no statistically significant protection by the BCG vaccine against tuberculosis. Holland does not have a BCG vaccine program, and they have the lowest TB death rate in Europe.

They don't know how or “if” it works
In the book Vaccines by Plotkin and Mortimer, under the heading 'Efficacy of Bacille Calmette-Guerin' it states:
“The true effectiveness of BCG vaccine has been debated for decades. Large clinical trials from the 1930s through the 1970s yielded wide-ranging and conflicting results, demonstrating efficacy from 0 to 80 percent. The most recent trial in India...only served to continue the argument...Even with years of study and debate, the question 'Does BCG work?' cannot be answered definitively.”
Also under the heading “Immune Responses to Bacille Calmette-Guerin Vaccine” it states:
“The exact immune response elicited by BCG vaccination and its mechanism of action within the host are not well understood...Studies of the immunological events that occur within the human host after BCG vaccination are almost totally lacking...Both animal data and human clinical studies have provided information about the immune response to BCG, yet for no vaccine so widely used, is so little known about its mechanisms of action.
“The immunology is complicated and development of an assay has been hampered by the lack of understanding of the protective response and the inability to identify specific antigens .. Given our incomplete understanding of tuberculosis immunology, we are left with imperfect indicators of immunity.”

Side effects
The side effects of the BCG vaccine include rash, fever, local induration, pain and lymphadenopathy, discharging ulcer, abscess formation, anaphylactic shock, lymphadenitis, difficulty in breathing, nausea, vomiting, phlyctenular conjunctivitis, draining sinuses, death.
In 1930, 73 children were killed by BCG vaccine in a few months. Dr. Neville Irvine's book, “BCG Vaccination in Theory and Practice,” reports of this disaster.
There had been a similar number of deaths in Spain when the Association of Spanish Pediatricians told its members not to use the vaccine. A report in the Medical Monitor (June 1992) also stated that the vaccine can give you TB.
“It can cause disseminated TB in immunosuppressed individuals, including children, and local ulceration and osteitis (wasting away of the bone) appears to be more common in babies.”
Complication rates for serious side effects from the vaccine were recorded at 3-6 children per 200 (1.5 percent to 3 percent).
Contraindications
The vaccine should not be administered if the recipient:
* Is taking steroids or any other immunosuppressive therapy such as radiation or chemotherapy.
* Has cancer or is HIV positive.
* Has a fever or skin condition such as eczema.
* Has had a previous reaction to a vaccination.
* Is allergic to any of the vaccine ingredients.
* Has had a vaccine in the last 3 weeks.
* Is pregnant
(from TB / BCG fact sheet © 1997-2001 VAN UK. Produced by Vaccination Awareness Network UK. 0870 444 0
Sources cited at this link http://www.van.org.uk/tb/bcg-tb_factsheet.PDF
The link to the package insert for Tubersol® is available online at the following link: http://www.vaccineshoppe.com/US_PDF/752-21_4611.pdf
The information in this 6-page insert is quite revealing and worth printing out and READING.

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THE VACCINE
You may be wondering at this point what good a vaccine against tuberculosis would do, when the cause of human tubercular disease is so obviously seated in a person’s environmental and social context. It is a good question.

Exposure to other common mycobacteria has been observed to confer a degree of protection against becoming infected with the tuberculosis bacillus. This was seen when children who drank unpasteurised milk developed mild forms of bovine tuberculosis but did not contract the human type. However, some people do worse, for example, those with the mycobacterial disease of leprosy (1).
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There are problems. Over the years the original live vaccine has evolved into an array of different strains with unknown properties and immungenicity (17). Very little is known about the correlation between dose of BCG and protection against tuberculosis in humans. A lot more is known about the dose of BCG required to give a certain size of response to tuberculin testing but this is not the same thing.
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The vaccine also interferes with the resistance created by exposure to local, non-pathogenic (friendly) mycobacteria. BCG vaccination may even be altering the body’s response to the tuberculosis bacillus in such a way that it is contributing to the resistance of tuberculosis to all of the drugs currently used to treat it. This is a global problem of massive proportions (1).

‘The history of immunisation against tuberculosis is a story of setback, controversy and surprise’ (20) said a leader in the Lancet in 1980. Trials of BCG vaccination have shown protection against tuberculosis to vary between zero and 78%. The best result was from a trial in UK school children from the 1950’s. In the 1960s, the Indian Research Council and the World Health Organisation carried out a very large, well designed, double-blind controlled trial of 360,000 people in Madras, South India. The results showed that more of those vaccinated with BCG got tuberculosis than those who had not been vaccinated (16).These discrepancies are not just due to the differences between the developed and the developing world. A recent study of children returning to the UK from the tropics showed that 75% of those vaccinated against Tb did not respond to tuberculin testing (a protective effect of 25% maybe?) (21). All of 62 cases of French hospital employees who had contracted tuberculosis at work had been vaccinated with BCG (22). Trials in the United States varied in protection from zero to 75% (16).

Many reasons have been put forward for the differences in the performance of the BCG in different trials and most of them, equally, have been refuted. What is clear is that where it is really needed it doesn’t seem to work. Even at best its efficacy appears to be much less than that claimed for other widely used vaccines.

It is when reading about research into new vaccines against tuberculosis that the full ineffectiveness of the BCG becomes most apparent. One also becomes increasingly aware of how little scientists and doctors know about tuberculosis at all. "Immunity to tuberculosis vaccine presents a daunting task in the face of our limited understanding of the organism’s virulence (ability to cause disease) and the host’s (human’s) immune response."(23) " "Understanding how the bacterium invades cells may be an important first step towards developing a vaccine to prevent tuberculosis."(24) -- I thought we already had one
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