RE: Vaccine roll out in a few weeks25 Oct 2020 15:08
There simply isn't a proven vaccine on the horizon yet. What we have at the moment can best be described as stepping stones with 200 vaccines in various stages of research and development. Given that all research into producing new vaccines has a failure rate of around 90% that leaves us with roughly 10% still at various stages of development. It's a very long and arduous process as often research which initially looks promising and where huge amounts of resources have been allocated will at a later stage unfortunately fail. It's the nature of all scientific research and even if time is shaved off some of the usual stages, bear in mind it usually takes 10 to 15 years of research and development before a vaccine is made available to the general public.
These are some of the stages a vaccine will have gone through before use:
* Literature review: looking at what has been done before.
* Theoretical development or innovation: coming up with a new idea, or a variation on an existing idea.
* Laboratory testing and development. This involves 'in vitro' testing using individual cells and 'in vivo' testing, often using mice. The vaccine has to pass rigorous safety tests at this stage, and demonstrate that it works in animals.
* Phase I study – an initial trial involving a small group of adult participants (up to 100 people). This is carried out to make sure that the vaccine does not have major safety concerns in humans, and also to work out the most effective dose.
* Phase II study – a trial in a larger group of participants (several hundred people). Phase II trials check that the vaccine works consistently, and look at whether it generates an immune response. Researchers also start looking for potential side effects.
* Phase III study – a trial in a much larger group of people (usually several thousand). Phase III trials gather statistically significant data on the vaccine's safety and efficacy (how well it works). This means looking at whether the vaccine generates a level of immunity that would prevent disease, and provides evidence that the vaccine can actually reduce the number of cases. It also gives a better chance of identifying rarer side effects not seen in the phase II study.
* Licensing – expert review of all trial data by the UK government (through the Medicines and Healthcare products Regulatory Agency - MHRA) or European regulator (European Medicines Agency - EMA). At this stage the regulators check that the trials show that the product meets the necessary efficacy and safety levels. They also make sure that, for most people, the product’s advantages far outweigh the disadvantages.
* Phase IV studies – post-marketing surveillance to monitor the effects of the vaccine after it has been used in the population. These may be requested by a regulatory body, or carried out by the pharmaceutical industry.
Source for stages: https://vk.ovg.ox.ac.uk/vk/vaccine-development
Hope thi
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