The Trial must be carried out in the target population for which you seek registration

Recommendation 2: The vaccine should be indicated only in those populations in which it has been trialled and found to have a positive benefit-to-risk ratio.

As our understanding of pathologies evolves, the number of sections of the general population (subpopulations) increases.

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As we get older, there may be a number of complex syndromes which may affect our well-being and susceptibility to ARIs, like metabolic syndrome or chronic respiratory problems. Knowledge carves up our general populations into many different penny packets, each with a different pathological profile. We may all respond differently to a challenge with one or more bugs or vaccines.

This is why we have concepts such as indications. Vaccine X is licensed for use in preventive ARI Y in this or the other population. In theory, we reach that decision through two stages. First, the vaccine is trialled in the target population. Based on the trial results, we assess whether its introduction into the schedule represents value for money, specifically whether the potential benefits outweigh the potential risks. This second stage is usually assessed in an economic evaluation during what is known as a Health Technology Assessment (HTA).

Honest economists like to base their estimates on trial evidence and take into account things like equity and externalities, i.e. the impact on society of introducing X, including, of course, the cost. That is because the cash spent on X cannot then be spent on cancer services or services for the disabled, for example. These non-spends are the opportunity costs of introducing X.

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If enablers, governments, and bio evangelists insist on scheduling X for populations in which the trials have not taken place, any HT assessment of the opportunity costs is based on guesswork, such as models based on assumptions.

There are many examples of this unethical and potentially reckless behaviour. One is Comirnaty, recommended for minors, frail elderly and pregnant women who were actually excluded from the registration trial.

The risks of COVID-19 for children and young people are minimal, while the long-term effects of the novel vaccines on children remain unknown. As a result, Jonathan Van-Tam, the deputy chief medical officer, had to use missing school as the target outcome.

“The point of infection, if left to happen, is not of their choosing, and may be at a point in their educational careers, thinking particularly of GCSEs and A-levels when it is extremely inconvenient to be laid low, albeit for a short number of days, with cough, fever, and respiratory symptoms,” Van-Tam said to MPs, 

This led to the farcical situation of Chris Whitty, the CMO, saying that "we are very clear this is not a silver bullet" but that it "will significantly reduce... the amount of disruption" to education. Yet, there was no evidence to support this benefit in the trials, and further misleading claims about benefits, stating that “that they will get it sooner or later because this is incredibly infectious... vaccination will reduce that risk."

The elderly are more at risk of Covid and the ideal population to target in a vaccine trial. However, the Kansas Attorney General's report highlighted that Pfizer did not test the booster on any participant older than 85 years old. 

The other example is influenza vaccines in the elderly, a category in which the last placebo-controlled trial was carried out 25 years ago. The evidence base for individuals over 65 comprises 5000 people across eight trials, with half focusing solely on effectiveness.

This post was written by two old geezers who do not like flights of fancy on other people’s skin.