From 1929 to 1933, 251 infants in

Lübeck Lübeck (; or ; Latin: ), officially the Hanseatic League, Hanseatic City of Lübeck (), is a city in Northern Germany. With around 220,000 inhabitants, it is the second-largest city on the German Baltic Sea, Baltic coast and the second-larg ...

, northern Germany, were given three doses of the oral

BCG vaccine The Bacillus Calmette–Guérin (BCG) vaccine is a vaccine primarily used against tuberculosis (TB). It is named after its inventors Albert Calmette and Camille Guérin. In countries where tuberculosis or leprosy is common, one dose is recom ...

against

tuberculosis Tuberculosis (TB), also known colloquially as the "white death", or historically as consumption, is a contagious disease usually caused by ''Mycobacterium tuberculosis'' (MTB) bacteria. Tuberculosis generally affects the lungs, but it can al ...

, which was accidentally contaminated with the bacteria responsible for the disease. 173 later developed signs of the illness and 77 died. It was initially thought that of the 77, only 72 died of TB causes.

Contaminated vaccine

This vaccine itself was initially blamed, until an inquiry headed by of the

Robert Koch Institute The Robert Koch Institute (RKI) is a German federal government agency and research institute responsible for disease control and prevention. It is located in Berlin and Wernigerode. As an upper federal agency, it is subordinate to the Federa ...

and Ludwig Lange of the Ministry of Health identified contamination as the cause. The event later became known as the Lübeck disaster, 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 ''The Lancet'' is a weekly peer-reviewed general medical journal, founded in England in 1823. It is one of the world's highest-impact academic journals and also one of the oldest medical journals still in publication. The journal publishes ...

'' and the ''

Journal of the American Medical Association ''JAMA'' (''The Journal of the American Medical Association'') is a peer-reviewed medical journal published 48 times a year by the American Medical Association. It publishes original research, reviews, and editorials covering all aspects of ...

''.

Legal consequences

On 6 February 1932, , the head of the

general hospital ''General Hospital'' (often abbreviated as ''GH'') is an American daytime television soap opera created by Frank and Doris Hursley which has been broadcast on American Broadcasting Company, ABC since April 1, 1963. Originally a half-hour seria ...

in Lübeck, was found guilty of

negligent homicide Negligent homicide is a criminal charge brought against a person who, through criminal negligence, allows another person to die. Other times, an intentional killing may be negotiated down to this lesser charge as a compromised resolution of a mur ...

and negligent

bodily harm Bodily harm is a legal term of art used in the definition of both statutory and common law offences in Australia, Canada, England and Wales and other common law jurisdictions. It is a synonym for injury or bodily injury and similar expressions, ...

, and sentenced to two years in prison. 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.

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.Marina Gheorghiu, Micheline Lagranderie & Anne-Marie Balazuc, "Tuberculosis and BCG", ''Vaccines: A Biography'', p. 133 (ed. Andrew W. Artenstein, 2009).Elizabeth Whittaker & Surinder K. Tamne, "Bacillus Calmette-Guérin (BCG) Vaccine" in ''Tuberculosis in Clinical Practice'' (ed. Inn Min Kon: Springer, 2021), pp. 16-17. After the tragedy, the oral route of administration for BCG vaccine was discontinued. It was replaced by alternate, improved methods of administration for the BCG vaccine:

intradermal Intradermal injection (also intracutaneous or intradermic, abbreviated as ID) is a shallow or superficial injection of a substance into the dermis, which is located between the epidermis and the hypodermis. For certain substances, administration ...

(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. 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. Compulsory BCG vaccination of infants was reinstated in

East Germany East Germany, officially known as the German Democratic Republic (GDR), was a country in Central Europe from Foundation of East Germany, its formation on 7 October 1949 until German reunification, its reunification with West Germany (FRG) on ...

in 1952.

References

External links

{{coord missing, Schleswig-Holstein 1929 health disasters 1930s health disasters 1929 in Germany 1930s disasters in Germany Health disasters in Germany Vaccine controversies History of Lübeck Tuberculosis deaths in Germany