BCG disease outbreak in Finland in the 2000's

BCG disease is an adverse effect of the Bacillus Calmette-Guérin

Bacillus Calmette-Guérin

Bacillus Calmette-Guérin is a vaccine against tuberculosis that is prepared from a strain of the attenuated live bovine tuberculosis bacillus, Mycobacterium bovis, that has lost its virulence in humans by being specially subcultured in an artificial medium for 13 years, and also prepared from...

vaccine

Vaccine

A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...

. The vaccine contains living Mycobacterium bovis BCG, and in BCG disease, the bacterium causes a disease in persons vaccinated. Between 2000 and 2006, several hundred children in Finland had serious adverse events from the vaccine, including osteitis

Osteitis

Osteitis is a general term for inflammation of bone. More specifically, it can refer to one of the following conditions:* Alveolar osteitis or "dry socket"* Condensing osteitis * Osteitis deformans...

and osteomyelitis

Osteomyelitis

Osteomyelitis simply means an infection of the bone or bone marrow...

, disseminated (usually fatal) BCG infection, arthritis, and lymph node abscesses. Four deaths were registered in the official adverse event register, and while in only two cases a clear causal link was considered to be in place, two other cases were diagnosed with a disease which in scientific peer-reviewed articles (case descriptions) have been mistakenly first made, and afterward have been noticed to be disseminated BCG infections. One death with a causal link considered established by the adverse event monitoring agency was vaccinated with pre-August 2002 vaccine (Evans), while the three other registered deaths were with the new post-August 2002 vaccine (BCG Vaccine SSI).

Vaccination policy in Finland

Officially, vaccination policy is divided to many governmental organizations like the National Agency for Medicines, National Public Health Institute, the National Authority for Medicolegal Affairs, National Research and Development Centre for Welfare and Health (STAKES), the Health Department etc. In practice, however, almost everything that's connected to vaccines is done with the National Public Health Institute. NPHI also does significant research funded by outside sources - ca. 40 % of funding is outside, and the policy is to get as much outside funding as possible. Among the biggest funders has been the vaccine giant GlaxoSmithKline between 2003 and 2005.

History

In the 1970s, there was a similar outbreak of BCG osteitis osteomyelitis in some Nordic countries, Sweden and Finland, when a Swedish-Danish BCG vaccine strain was used. To resolve the issue, Sweden discontinued mass BCG vaccinations to newborns, and Finland switched to a different strain.

Beginning of the outbreak

In August 2002, the BCG vaccine used in Finland was discontinued by the manufacturer after factory inspectors were dissatisfied with the manufacturing process. Finland switched to a Danish strain BCG vaccine which did not have marketing authorization in Finland. Despite lack of marketing authorization, the vaccine was offered and recommended to all Finnish newborns (ca. 55 000 - 60 000 per year), and parents were not told the vaccine had no marketing authorization as required by Finnish and European Union legislation. The vaccine was injected into the thigh of newborns, despite clear manufacturer instructions that the vaccine shall be administered into upper arm, and despite manufacturer's warning that injecting into a lower limb is associated with a greater number of adverse effects.

Publicity and continued vaccinations

Severe adverse effects were noticed in the media already in the Spring of 2003, and on 27. May 2003, a grandmother also working in the medical trade called for discontinuation of the vaccine. However, vaccinations continued as before, and representatives from the National Public Health Institute of Finland and an expert group set by NPHI responded on 3 June 2003 that there was no need to change the recommendation concerning vaccinations. In fact, already in December 2002, a decision had been made to actively move towards vaccinating only those newborns at special risk for tuberculosis.

Resolving the issue

While National Public Health Institute of Finland

National Public Health Institute of Finland

The National Public Health Institute of Finland was a research and expert institute under the charged with the task of protecting and promoting health in Finland. KTL was founded in 1911; the final form was established in 1982 in order to promote public health in Finland.The institution had a...

was prepared to let the vaccine be administered to all newborns until the beginning of 2008, mass vaccinations were discontinued in 1 September 2006 after a draft report by Finnish Lung Health Association (Filha ry) which clearly stated that the vaccine does more harm than good for that specific population.

Aftermath

On January 4, 2009, Rokotusinfo ry issued a media release saying that it has requested the police to investigate whether there have been crimes committed relating to use of the BCG vaccine.