Warning against the Off label Use of BCG Products

In Germany, immunostimulatory products on the basis of bacteria preparations derived from the Bacillus Calmette-Guérin (BCG) mycobacterial strain are authorised for the treatment of urinary bladder carcinoma.

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has issued a warning that the BCG products available in pharmacies are not authorised for the treatment or prevention of COVID-19.

This warning refers to the following BCG products:

BCG medac,
Marketing authorisation holder: medac Gesellschaft für klinische Spezialpräparate mbH, License No. 151a/92

BCG medac,
Marketing authorisation holder: CC-Pharma GmbH, License No. PEI.H.03580.01.1

Marketing authorisation holder: Organon Teknika GmbH, License No.177a/89

Compared with a vaccine, BCG products contain significantly higher concentrations of immunostimulatory substances, which, in the event of non-conforming use of these products as vaccines, can present a risk for patients.

Besides, these BCG products are required for the treatment of urinary bladder cancer. Against the backdrop of the existing supply shortage at BCG medic, the use for non-authorised indications may further jeopardise the care for affected patients.

For this reason, the Paul-Ehrlich-Institut requests doctors and pharmacists to review the establishment of an indication in a critical manner.

  • Paul Ehrlich Institut –