UNLESS we control & adjust for early treatment use, recovery with natural immunity, healthy vaccine user effect & co-morbidities, then the COVID vaccine & booster studies by Pfizer & Moderna are junk
by Paul Alexander
The 4 named above are potent possible confounders that could confuse findings in VAX epidemiological studies; randomized controlled trials (large same size & outcomes) address; these remain absent
So be careful in any interpretation. As an academic scientist, I wish to comment. As of this writing, there have been no randomized controlled trials for any COVID vaccine showing a beneficial effect in reducing hospitalization or death.
Parceling out early treatment and established immunity as well as healthy vaccinee bias effect is critical. I have mentioned these before and thus my assertion that the present vaccine studies are not interpretable and report biased estimates of effect; observational epidemiological studies (especially with statistical control for important known confounders) are very potent and can, once properly designed, even supersede poorly conducted randomized controlled trials (RCTs) (with sub-optimal randomization, allocation concealment, blinding, heavy and differential data loss across groups, stopping early for benefit (a random high if not completed to planned sample size), selective outcome reporting etc.).
The potency of randomization is that it controls for both known and unknown confounders (distorting variables) for you can never really list the unknown ones. Yet the issue is that of how important are they and the issue is that of sample size and outcome size. Dr. Risch has explained well that small outcome events can be catastrophic also as would breach randomization.
The RCTs conducted by Pfizer and Moderna have all been poorly conducted and were destroyed and subverted when they stopped early for benefit, and they gave vaccine to the placebo control group, in effect, ending the studies. There was no longer a comparative group. Importantly, when we say ‘early treatment’, it is never that any one therapeutic is sufficient but especially as with anti-virals, we looked for signals of benefit and used in combination and sequenced. Combined therapeutics.