1930 – Lubeck BCG Vaccine
In 1930, the Lubeck catastrophe occurred, casting doubts on the safety of the BCG Vaccine.
BCG, or Bacille Calmette-Guerin, is a strain of the attenuated (virulence-reduced) live bovine tuberculosis bacillus, Mycobacterium bovis, that has lost its ability to cause disease in humans commonly known as TB. In the German city of Lubeck, 251 infants were given BCG that came originally from the Pasteur Institute in Paris, but it was prepared for administration in the TB laboratory in Lubeck.
Seventy-two of the children developed TB and died within a year as a result of the disease.
Another 135 children developed clinical tuberculosis, and only 44 survived.
A subsequent investigation, carried out by German TB experts, revealed that the vaccine had become contaminated with a non-attenuated live virus strain during its preparation at a local laboratory. Two people who had worked in the local laboratory were sent to prison in 1932 for “bodily injury due to negligence. Thorough investigations following this incident revealed that batches of the vaccine were contaminated with the so-called ‘Kiel’-strain.
So, what GMP lessons can we learn from this?
The batches of vaccines, and all drugs, should have been tested for identity, purity and safety according to written and approved standard operating procedures, before releasing them into the market. The same testing should have been performed at the local laboratory responsible for the contamination event.
