From 1929 to 1933, 251 infants in Lübeck, northern Germany, were given three doses of the oral BCG vaccine against tuberculosis, which was accidentally contaminated with the bacteria responsible for the disease. 173 later developed signs of the illness and 72 died.[1][2]

Contaminated vaccine

This vaccine itself was initially blamed, until an inquiry headed by Bruno Lange of the Robert Koch Institute and Ludwig Lange of the Ministry of Health identified contamination as the cause. The event later became known as the Lübeck disaster,[1][2] or in German, the Lübecker Impfunglück (Lübeck vaccine disaster). Major scientific journals worldwide commented on the disaster and subsequent trials of the medical staff, such as The Lancet[3] and the Journal of the American Medical Association.[4]

On 6 February 1932, Georg Deycke, the head of the general hospital in Lübeck, was found guilty of negligent homicide and negligent bodily harm, and sentenced to two years in prison.[5] Deycke negligently cultivated the BCG vaccine in a laboratory unsuitable for vaccine production and refrained from animal experiments. Ernst Altstaedt was sentenced to 15 months in prison for negligent homicide and negligent bodily harm as he did not test the vaccine in animal experiments and only insufficiently observed the children. The co-accused chairman of the Lübeck health department, Max Klotz, was acquitted, as was Deycke's laboratory assistant, Anna Schütze.[6]

Subsequent developments

Despite the investigation's finding that contamination caused by laboratory error (not the BCG vaccine itself) was the cause of the deaths, the Lübeck disaster diminished public confidence in, and usage of, the BCG vaccine for a time.[7][8] After the tragedy, the oral route of administration for BCG vaccine was discontinued.[9] It was replaced by alternate, improved methods of administration for the BCG vaccine: intradermal (ID) (introduced 1927), multiple puncture (1939), and scarification (1947). The First International BCG Congress in Paris, held in 1948, concluded that the BCG vaccine was safe and effective.[10] With the BCG vaccine's safety and effectiveness established, and new methods of administration, confidence in the BCG vaccine was restored, and mass vaccination campaigns resumed globally.[7][8] Compulsory BCG vaccination of infants was reinstated in East Germany in 1952.[11]

References

  1. 1 2 Fox, Gregory J.; Orlova, Marianna; Schurr, Erwin (21 January 2016). "Tuberculosis in Newborns: The Lessons of the 'Lübeck Disaster' (1929–1933)". PLOS Pathogens. 12 (1): e1005271. doi:10.1371/journal.ppat.1005271. ISSN 1553-7374. PMC 4721647. PMID 26794678.
  2. 1 2 Luca, Simona; Mihaescu, Traian (2013). "History of BCG Vaccine" (PDF). Mædica. 8 (1): 55. PMC 3749764. PMID 24023600.
  3. ↑ "REPORT ON THE LÜBECK DISASTER". The Lancet. 215 (5571): 1244. June 1930. doi:10.1016/s0140-6736(00)70979-2. ISSN 0140-6736.
  4. ↑ Lohse, Hanna (2021). "The BCG disaster, Lübeck, 1930: An Oral History Project of the 'Calmette Children' and their Survivorship". International Journal of Urologic History. 1 (1): 12–18. doi:10.53101/IJUH71213.
  5. ↑ Akgün, Burhan; Hot, İnci (2015). "[DEYCKE PASHA AND THE LÜBECK DISASTER]". The New History of Medicine Studies (21): 11–37. ISSN 1300-669X. PMID 30717502.
  6. ↑ Hanna Elisabeth Jonas. (2017) The Lübeck vaccine disaster of 1930 as perceived by contemporary witnesses, pp. 94–95, Dissertation, Lübeck, 2017 (in German)
  7. 1 2 Marina Gheorghiu, Micheline Lagranderie & Anne-Marie Balazuc, "Tuberculosis and BCG", Vaccines: A Biography, p. 133 (ed. Andrew W. Artenstein, 2009).
  8. 1 2 Elizabeth Whittaker & Surinder K. Tamne, "Bacillus Calmette-Guérin (BCG) Vaccine" in Tuberculosis in Clinical Practice (ed. Inn Min Kon: Springer, 2021), pp. 16-17.
  9. ↑ R.E. Huebner, "BCG Vaccination in the Control of Tuberculosis" in Tuberculosis (ed. T.M. Shinnick: Springer, 2013), p. 267.
  10. ↑ Kim Connelly Smith, Ian M. Orme & Jeffrey R. Starke, "Tuberculosis vaccines" in Vaccines (6th ed.), p. 727. Elsevier/Saunders: Eds. Paul A. Offit, Stanley A. Plotkin, Walter A. Orenstein (2013).
  11. ↑ Escobar, Luis E.; Molina-Cruz, Alvaro; Barillas-Mury, Carolina (28 July 2020). "BCG vaccine protection from severe coronavirus disease 2019 (COVID-19)". Proceedings of the National Academy of Sciences. 117 (30): 17720–17726. Bibcode:2020PNAS..11717720E. doi:10.1073/pnas.2008410117. ISSN 0027-8424. PMC 7395502. PMID 32647056.

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