In a previous article, we touched on the unfinished nature of Covid vaccine phase III trials. This whole business of clinical trials could do with some examination, so in this article, we will cover what the various phases are and discuss why there is confusion about what ‘finished’ means (particularly for phase III) and relate this to the Covid vaccines.
There are three phases to complete before a treatment or vaccine can be submitted to the FDA for commercialisation. In addition, a fourth phase may be required to further monitor longer-term safety. These phases are:
- Phase I : Demonstrate treatment safety and find where it distributes in the body.
- Phase II : Determine dosage levels and effectiveness in treatment or prevention of infection.
- Phase III : Determine safety and effectiveness using a wide variety and larger number of people.
- Phase IV : Monitor safety and medium to long term adverse reactions.
Normally what happens is that the phases are run one after the other, and the next one is not begun until the current phase is deemed successfully finished. This is generally a lengthy process, and research and development make it even longer:
- Research and development : 3 – 6 years
- Phase I – III : 6 – 7 years
- FDA review/manufacturing : 0.5 – 2 years
- Phase IV/ongoing monitoring: 0.5 – 10+ years
So what happened with the Covid vaccines, then? Taking Pfizer as an example, they ran overlapping Phase I/II and Phase II/III trials. The Phase I/II (combined Phase I and II)) started on 4 May 2020 and reported results on 17 August 2020; similarly the Phase II/III (combined Phase II and III trial) began on 27 July 2020 and reported results on 18 November 2020. The Phase II/III report uses words like ‘conclude’, which seems to indicate the trial is completed but later on in the article it mentions that the trial is ongoing.
So is the Phase II/III trial finished or ongoing? The confusion here relates to the reporting of the efficacy and basic safety data being complete (i.e. enough data to calculate them). However, the other parts (particular to the Phase III part of the trial), such as medium or long term safety, are ongoing.
This provides fodder for disingenuous governments to claim that the vaccine has completed all trials. However, suppose we accept that for the moment – look at the time frame: that would be just under 4 months to complete the Phase II/III trial! Contrast that with the numbers above (6-7 years for all 3 phases). Clearly, no medium or long term safety data is available after such a short time. There is no way that a claim of ‘safe and effective’ can be justified on the basis of such abbreviated time frames!
Now (we hear them already) there are the proponents of the narrative that say ‘Yes, but technology can develop vaccines faster now – you need to keep up with progress’. It is certainly true that we can develop vaccines very quickly with these new methods – but we cannot test them any faster. That is the rub, and it is clear that this is where things have fallen down! Whistleblowers from Pfizer’s contracted test labs in Texas have highlighted massive procedural failings during the trials, and this clearly shows that rather than ‘operating at the speed of science’ they were simply failing to operate. Thus the concerns of the vaccine-hesitant are justified on this point.
All this ties into the question of whether the massive coercion to have these vaccines violates the Nuremberg Code. This in turn relies on the vaccines being classed as ‘experimental‘. Given the rushed time frames, shambolic quality control of subcontractors in the trials and the initial emergency authorisation, the only sensible answer is that yes, there are grounds for saying they are still experimental!
This observation makes it clear why so many important facts were still unknown as these vaccines were rolled out (e.g: how long the generated immunity lasted and whether they stopped transmission) – because the trials had been rushed and there was not time to measure these things!
Finally, what about Phase IV? Crickets. Surely, when we have vaccines developed quickly and with novel delivery medical technology, a Phase IV should be an obvious safety choice?