I stopped reading at the part where he spends a full page on semantic games around the precise meaning of the word vaccine, misspelling the name of a famous dictionary in the process. This person is clearly not being honest about his intentions.
Nothing is misleading. Half the participants got the vaccine, the rest placebo, before going about their usual lives. Now, a few months later, 95 cases have been confirmed across both groups. Of these, 90 had received the placebo and only 5 the vaccine. If the vaccine didn't work at all, the split would be roughly 50/50. A somewhat effective vaccine might result in a 70/30 split, and so on.
It's the standard method, and I see nothing wrong with it. What you suggest (deliberate exposure) is called a challenge trial. This is normally considered ethical only when an effective cure (e.g. antibiotics) is available. Even so, there are plans to conduct such a trial in the UK, and there's no shortage of volunteers. We'll see if they get approval.
In the Pfizer trial, all the subjects in the interim evaluation had symptomatic infection confirmed by PCR test. I'm not sure about Moderna, but it's likely to use the same or similar methods.
One factor speeding up the phase 3 trials is the high rate of infections. Since the evaluation is done at a set number of confirmed cases among the test subjects, this happens much sooner for covid than it would be for just about anything else at this time.
Another factor is money. The covid vaccine trials have done some testing steps in parallel that would normally be done sequentially to avoid wasting money should it fail along the way. So yes, more risks are being taken, but they are financial, not clinical.
> So yes, more risks are being taken, but they are financial, not clinical.
While most vaccines produced so far have been quite safe, there are three known cases I'm aware of that weren't, (Early 1950s attenuated Polio vaccine that caused polio, H1N1 Pandemrix vaccine making narcolepsy 6-fold more prevalent in sweden in 2009, swine flu vaccine increasing risk for guillan-barre in 1976).
Of these, the 1st and the 3rd were rushed out. So I wouldn't say "no clinical risks". There's some info here[0], though it's not complete
In all three cases I mentioned, as far as I know there was either immediate indication or suspicion raised within the 1st year, but took several years to reach conclusions.
The polio case was very clear very quickly, the others not so much.
There's quite a bit about long term autoimmune response that we don't understand. I'm not up-to-date on everything, but from what I remember, strep-A infection is associated with increased likelihood of RA decades later; Epstein Barr exposure (causing Giullan Barre in children and Mono in adults) is associated with higher probability for MS, and there are a few other such suspected causalities - autoimmune diseases are no joke, and it seems like they can be triggered by either a pathogen (virus, bacteria) or a vaccine (which is designed to provoke the same kind of immune reaction without letting the pathogen do harm).
On average to society, it is almost sure that if nothing becomes suspicious within a year, it is a net gain.
To individuals, the question is much more complicated - autoimmune diseases often appear in clusters; I think it is prudent for people with a history (or even family history) of autoimmune disease to hold off as much as they can - as it may take years or decades to figure out how it effects the unlucky ones (of which they are much more likely to be).
Both groups have (approximately) the same size, in the tens of thousands. The first evaluation is done when 90 or so cases have been confirmed, not knowing which group they belong to. The blinding of these subjects is then unsealed, in this case revealing that 90 of the 95 confirmed infections occurred in the control group. This distribution means the vaccine has been highly effective at preventing infection.
Sorry, I meant just 90 people infected (obviously the vaccine arm has much fewer), but after running the numbers that's actually about right for the prevalence rate we see in the US.
This isn't the final evaluation. There will be another at ~150 cases. The numbers may seem small, but this is enough for the purpose of deciding for or against approval. Anything over 80% effectiveness would likely be approved, so it doesn't matter whether the true value (insofar one exists) is 90%, 95%, or something in between. It's useful regardless.
Oh, I didn't know that, thanks. I'm sure it's enough for statistical significance given the difference, I was just wondering why there were so few cases in 30k people, but it looks like that's just the normal case rate.
Exactly. It's a good sign if people develop antibodies, but that does not ensure protection. As I understand it, it is difficult to predict, in advance of actual testing, what immune response will actually be protective.
