BRUSSELS—Last week the European Pharmacopoeia Commission announced its decision to modernize Europe’s accepted process for safety assessment of vaccines for pertussis, commonly known as whooping cough, by adopting a modern cell-based method in place of an inhumane and unreliable test in mice. Pertussis is known for uncontrollable, violent coughing, which often makes breathing difficult. Previously, government health authorities required the extensive testing for vaccine quality and safety before products are approved and marketed for human use, a process that inflicts severe pain and distress on millions of animals each year worldwide.

Laura Viviani, HSI regulatory science advisor for vaccines, said: “Humane Society International welcomes the decision to remove the mouse histamine sensitisation test and associated testing requirements from the European Pharmacopoeia, and the adoption of a more reliable cell-based test in its place. The mouse test has long been scientifically criticized for its high variability and poor reproducibility, which often leads to repeat testing, with associated costs, delays and needless animal suffering. The European Commission is to be commended for embracing the use of historical safety data confirming the consistency of different batches of pertussis vaccine in place of cruel and repetitive animal testing of each and every new batch.”

Removal of the mouse histamine sensitisation test from the European Pharmacopoeia will become effective on 1 January 2020, and could spare as many as 36,000 mice used yearly for pertussis vaccine testing for the European market. This decision, coming exactly one year after the authority officially scrapped another notorious animal study, the Abnormal Toxicity Test, further reinforces Europe’s commitment to the elimination of animal testing.

HSI is urging vaccine manufacturers and authorities globally to follow Europe’s example by embracing the “consistency approach,” which combines good manufacturing practices to ensure quality and consistency of vaccines with an accurate historical analysis of safe use and of lot releases. This approach is ripe for application to a host of human vaccines, such as tetanus, diphtheria and rabies, which continue to undergo invasive animal testing for every new manufactured batch.

Facts:

• Worldwide approximately 65,000 mice are used for the histamine sensitisation test each year: 48,000 by manufacturers and 17,000 by national control laboratories. These tests covered the release of approximately 850 lots of pertussis vaccines each year. (Hoonakker, M. et al. Safety testing of acellular pertussis vaccines: Use of animals and 3Rs alternatives. Hum Vaccin Immunother. 2017;13:, 2522-30)
• The mouse histamine sensitisation test is used by manufacturers and control laboratories to verify the safety of the pertussis vaccines by checking the presence of residual toxin in the vaccine.
• Most regulatory authorities require a “lethal challenge” procedure, in which groups animals are infected with a virus or other disease agent after being immunized with different dilutions of a vaccine. Animals in the “control” group are given no vaccine, and are left to suffer, without pain relief, until they die.
• Humane Society International supports the “Three Rs” approach to animal testing: replace animal testing with alternative methods, reduce the use of animals in testing, and refine testing procedures to minimize animal suffering.

Media contact: Nancy Hwa (Washington, D.C.), nhwa@hsi.org