• Question: What ways are there of testing whether or not a vaccination will be potentially harmful to the subject being inoculated? E.g. not good for infants. Is it always guesswork, " Oh, we'll just divide the adults' dose by two, no three!" Do you pay test subjects, potentially endangering their lives?

    Asked by nkdee to MarkF, Mark, Michael, Panos, Sarah on 17 Jun 2010 in Categories: .
    • Photo: Mark Fogg

      Mark Fogg answered on 15 Jun 2010:

      I sense from the way your question is phrased that you are a little cynical about the clinical trial process

      There’s a very good web site all about clinical trials here
      http://clinicaltrials.gov/

      No, it is never just guess work, such decisions are always made in the light of evidence. If they are not, than it’s bad scientific practice.
      NOTHING is 100% safe. No GOOD and ethical scientist will ever claim 100% certainty for anything.

    • Photo: Panos Soultanas

      Panos Soultanas answered on 16 Jun 2010:

      Hi nkdee,

      Usually testing on some animals or human volunteers. The safety regulations before proceeding to testing are very strict though and usually there is no great danger involved. Safety is very important in science. We (scientists) value life a lot and the last thing we want to do is to endanger anyone. we aim to help people and not to make things worse.

    • Photo: Sarah Burl

      Sarah Burl answered on 16 Jun 2010:

      When testing any vaccine you start off with a very small dose to check for safety then increase the dose and look for further safety and then efficiacy. If there is any serious adverse reaction to the vaccine the trial is immediately stopped. It is not ethical to pay people to do trials it has to be voluntary. Money is sometimes given in the form of compensation for the loss of work and time while being part of the study. It is true that some trials are more risky than others and the compensation will reflect that. In the case of infants in the Gambia the mothers have to consent for the child’s sake. We give free healthcare for all the family for the length of the study or for at least one year which ever is longer.

    • Photo: Mark Travis

      Mark Travis answered on 16 Jun 2010:

      I think this is a very good question!

      They definitely do not pay people to test on them in situations they think are dangerous. They will do tests of chemicals (and vaccines) in animals to check for toxicity. I am not exactly sure how they decide on doses for different age humans….. probably a question for a pharmacologist.

    • Photo: Michael Loughlin

      Michael Loughlin answered on 17 Jun 2010:

      Its never guesswork..its alwasy based on what we know…what structures we know will trigger immunity, making sure that the virus or bacteria being used is dead, or inactive
      Lots of different areas of biology coming togther
      immunology ,
      genetics ( are all people the same..no, therefore everyone will have a slightly different reaction to the vaccine. Statistics..on average how many people will have a different response..if its too many should we even be looking at this as a vaccine.
      Microbiology..is there any other part of the bacteria that triggers the immune reponse and will kill it?
      Is there part of the immune reponse the bacteria is resistant to..should be bothere trying to switch that on…
      are childrens immune systems the same..do they get this disease often ..if not would it be better to wait until their immune systems are stronger before giving the vaccine
      How bad is this flu going to be..should be vaccinate everyone to stop them getting a cold..or just the weaker immunosuppressed people..

      all these things just scratch the surface of what goes into looking at a vaccine..
      test subjects i believe are paid and any risks expalined to them fully

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