A Novel Microbe, Immunization Deaths, and Vaccination on Trial: BCG and the Lübeck Disaster of 1930.

Today's controversies of gain-of-function virological research and mRNA COVID vaccination policies had an antecedent nearly a century ago in an event often referred to as "the Lübeck disaster." From April through September 1930, 77 newborn infants in Lübeck, Germany, died after receiving oral BCG immunizations tainted with active human . The tragedy threatened to end BCG immunizations. BCG and its originators, the French scientists Albert Calmette and Camille Guérin, were exonerated from liability. An inquest uncovered careless laboratory practices that contaminated doses of the vaccine with a human pathogen. The calamity underscored the necessity for exacting standards when handling dangerous infective microbes. The physician and bacteriologist responsible for the immunization program in Lübeck were tried and convicted for negligence, a concrete example of the civic responsibility expected of scientists when an experimental venture inflicts harm on an unwitting public. The example of Lübeck stands as an object lesson on the necessity of an informed, measured approach to any novel treatment. Controversies continue whether BCG vaccination is the preferred public health strategy against tuberculosis. Calmette and Guérin's lasting scientific achievement is the creation of a microbe that over a century has kept its essential features of inciting a vigorous immunological reaction that was tolerated by its host and never regaining its pathogenicity. The features form the basis of modern cancer immunotherapy, where intravesical BCG is first-line therapy against non-muscle invasive bladder cancer.