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BSI response to BMJ investigation into the use of animal studies in the development of a TB vaccine

11 January 2018

The British Medical Journal has published an investigation into the conduct of researchers regarding the results of animal studies to gain funding and approval for human trials to test a new tuberculosis vaccine, MVA85A. In response to this report, the British Society for Immunology has released the following statement:

Professor Anne Cooke, Vice-President of the British Society for Immunology, said:

“Vaccines, which work by boosting a specific immune response against an infectious agent, are one of the most effective public health interventions and have saved millions of lives.  The development of a safe and effective vaccine takes many years and needs to go through many different stages of testing, including work on cells, testing on animals and finally clinical trials on humans. 

 “At each stage of development, it is important that experiments are meticulously and rigorously designed and analysed to allow us to be confident in their findings and allow proper evaluation of the safety and efficacy of the drug by academics and ethical committees. This is particularly true for pre-clinical experiments (i.e. those involving animals) and clinical trials conducted on humans. While the scientific community aims to reduce the number of animals used in research, this is currently a crucial step in testing a new drug before it is given to humans in clinical trials.  Experiments carried out on animals should always have a clear aim and adhere to the principles of the 3Rs (replacement, reduction, refinement) to minimise animal numbers and suffering.  Studies should only progress to clinical trials in humans if there is clear evidence from animal models showing safety and efficacy of the drug concerned.

 “The development of new vaccines has potential to deliver huge public health benefits to tackle diseases that affect millions of people worldwide.  To realise this potential, as researchers working in this field, we have a responsibility to ensure that the experiments we carry out are rigorous and that we are transparent and open with the scientific community and the public about their results.” 

The full investigation that this comment is in response to can be found at:

  • Cohen 2018 Oxford vaccine study highlights pick and mix approach to preclinical research. British Medical Journal 360 j5845 doi: 10.1136/bmj.j5845.

Alongside this investigation, the BMJ also published the following editorials:

  • Macleod 2018 Learning lessons from MVA85A, a failed booster vaccine for BCG. British Medical Journal 360 k66 doi: 10.1136/bmj.k66
  • Ritskes-Hoitinga & Wever 2018 Improving the conduct, reporting, and appraisal of animal research. British Medical Journal 360 j4935 doi: 10.1136/bmj.j4935

A response from the researchers involved can be viewed at:

  • McShane et al. 2018 Development of a new tuberculosis vaccine for humans. British Medical Journal 360 doi: 10.1136/bmj.j5845