Magen et al. NEJM "Fourth Dose of BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting"; serious methodological concerns with this study, so I question this study

by Paul Alexander

This is not a randomized controlled trial & the FDA has failed the public in ensuring this; there is a real potential for confounding in this observational study (residual confounding); I question the results


Fourth Dose of BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting

4th dose, Pfizer vaccine

Observational study, not RCT

4th dose people are likely different than 3rd dose (likely healthier behaviors etc.) and opens the door for residual ‘confounding by indication’ confounding…there are differences other than the 4th vaccine dose that caused the effect

You confound by the reality that you chose to take the 4th dose. I think they have not done the job of removing the risk of residual confounding, even with the matching.

Look at the Figure 2 graph c, how could there be that difference at day 7 that splits off so much? Can there really be that difference in hospitalization day 7 or 8 due to vaccine? Can we not argue that it is too soon for the hospitalization effect to emerge and be so divergent? Can these 2 groups be fundamentally disparate to begin with?

Look at severe COVID day 7 and deaths day 14 in Figure 2. Can this not be too rapid to see this difference? It may well be that due to the lack of a RCT design, that we are seeing confounding that is distorting the true effects of the vaccines.

Dr. Tenenbaum asks a significant question which is the very same people say you are only ‘vaccinated’ post 14 days but for their study, they are looking at 7 days etc. See the fraud?

The key question I ask is how come the vaccine makers have not yet swapped out the failed vaccine as it does not hit the spike? Is this to just get rid of the millions or billions of doses? If the vaccine is based on the original Wuhan strain, should the vaccine not be adjusted for the new predominant variant? Why continue a failed vaccine?