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“Covid-19 Vaccine in Phase II Clinical Trials” – what does it all mean?

With recent talk about potential Coronavirus vaccines going into Phase I and II Clinical Trials, I thought it might be quite timely to discuss what this means, i.e. what the clinical trial process is, and why it often take so long for a new therapeutic agent to come to market.

For those of you with a medical or science background you may already have some idea of what I’m referring to here, though even then, it may not always be clear for you what the various steps are, or how they’re carried out. And for those with no relevant training in this area, then talk of clinical trials at any level is probably gobbledygook! Whichever the case, read on and I’ll do my best to explain it all for you. Buckle-up though – it can be a bit complicated at times!

All over the world, government agencies are incredibly strict in their regulation of new therapeutic agents that come to market, including pharmaceutical drugs, biological agents (such as vaccines), over-the-counter drugs purchased in pharmacies, and even those hotly debated colourings, preservatives and other food or drink enhancement compounds, to say the least. In simple terms, the companies offering (or using) these products, must seek approval to do so from their own local, and at the same time, international, regulatory bodies. The idea is to make sure that whatever comes to market has been shown to be useful, safe and effective and, beyond that, to monitor the long-term use of those agents and report back any significant side-effects or related problems. Governments have dedicated personnel and departments to carry out such assessments so, for example, the USA have the Food & Drug Administration (FDA), the UK have the Medicines & Healthcare Products Regulatory Agency (MHRA) and in Australia our Therapeutic Goods Administration (TGA), fill that role. Almost all countries around the globe have their own similar version.

When a company want to market a new drug or biological agent then they must first satisfy the appropriate government body and, in order to gain that all important stamp of approval, they need to provide substantial ‘evidence’ in the form of ‘Clinical Trial’ results. Essentially this means that the product must go through a very lengthy and rigorous process of being tested - first in the lab, then in animal models, and finally in humans. Once again, the human trial component is split between various stages in order to make sure that it is useful, safe and effective. Nothing can be rushed, because each stage must be successful in order to proceed to the next.

The process is complex, but goes something like this …

(1) Pre-clinical trials:

Pure research phase: Researchers begin with a new compound or biological agent and test it for potential therapeutic use; sometimes they begin with the end in mind, and sometimes not. Throughout this stage of the research, no testing is performed on human beings. Usually the testing begins in the lab and, if useful, progresses to testing in animal models (usually mice), helping the researchers to evaluate the product’s potential effects, and safety.

  • Initial investigations

  • Lab testing

  • Animal studies only

  • Toxicology (is it poisonous?)

(2) Clinical trials - human testing:

Phase I Clinical Trials: If the product looks useful in the lab then testing will progress