Debunked as usual
Dr. Aseem Malhotra tells Joe Rogan that a reanalysis of Pfizer and Moderna's original clinical trial data shows that their COVID mRNA vaccines *INCREASE* your risks of serious adverse events, hospitalization, and death: "In my whole career, looking at all of the drugs and knowing about many different prescribed medications, I've never seen something that when you look at the data has such poor effectiveness and unprecedented harms. In the summer of last year, in the journal Vaccine, the highest-impact medical journal for vaccines, they published a reanalysis of Pfizer and Moderna's original double-blinded randomized controlled trial. This is the highest quality of scientific evidence. Joseph Fraiman is an ER doctor and clinical data scientist from Louisiana. Associate editor of the BMJ, Dr. Peter Doshi. Dr. Robert Kaplan from Stanford. Some real eminence of integrity published this reanalysis, and what they found was this. In the trials that led to the approval of regulators worldwide, you were more likely to suffer a severe adverse event from taking the vaccine, hospitalization, disability, or life-changing event than you were to be hospitalized with COVID. This mRNA vaccine should likely have never been approved for a single human in the first place, and that rate of serious adverse events is at least 1 in 800... 1 in 800 is a very, very high figure. We've pulled other vaccines for much less. The 1976 Swine Flu vaccine was pulled because it was found to cause a debilitating neurological condition called Guillan-Barre syndrome in about 1 in 100,000 people. The Rotavirus vaccine was suspended in 1999 because it was found to cause a form of bowel obstruction in kids in 1 of 10,000. This is at least 1 in 800. It's a no-brainer. So the question is, why have we not paused it?"
And part of the article directly addressing this:
Reanalysis of clinical trial data from Pfizer and Moderna
One of the main pieces of evidence in the article is a study published by Fraiman et al.
in the journal Vaccine. In it, the authors analyzed data from a previous study of adverse events reported in the clinical trials of the Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines[2,3]. They concluded that “The excess risk of serious adverse events of special interest was higher than the risk reduction for COVID-19 hospitalization relative to the placebo group” in both Pfizer and Moderna trials.
To arrive at this conclusion, the authors calculated how many more serious adverse events occurred in the vaccinated group compared to the control group. They then compared this figure with the number of people hospitalized with COVID-19 during the clinical trials.
To determine what kind of adverse events would be considered as serious for the purposes of the study, the authors looked to the Priority List of COVID-19 Adverse events of special interest
by the Brighton Collaboration
(BC), a program of the nonprofit organization The Task Force for Global Health
. This list includes adverse events that have been seen with COVID-19, as well as those with a proven or theoretical association with vaccines in general or with specific vaccine platforms.
The now-published study was initially available as a preprint—a manuscript that hasn’t undergone peer review—in June 2022. Health Feedback previously reviewed it and found that the authors’ analysis didn’t support their conclusion. Scientists such as surgeon and cancer researcher David Gorski, biostatistician Jeffrey S. Morris, and nanomedicine expert Susan Oliver pointed out several issues in the study that indicated potential p-hacking.
P-hacking (also known as data dredging or data snooping) is the manipulation of data analysis to make the results look statistically significant when they aren’t. The study by Fraiman et al. showed several signs suggesting that the authors had analyzed data in a manner that favored their hypothesis.
First, the Brighton document
lists “adverse events of special interest” (AESI) mainly as specific clinical diagnoses, such as enteritis/colitis, arthritis, and encephalitis. In order for the authors to count the number of serious AESIs associated with COVID-19 vaccines, they needed to determine which serious adverse events (SAEs) recorded in the vaccines’ clinical trials corresponded to the AESIs listed in the Brighton document.
The decision of whether an SAE corresponded to a Brighton AESI rested on the opinion of two independent clinicians, and a third one if the first two disagreed without arriving at a consensus.
However, the reasons for considering certain SAEs as corresponding to the AESI list are unclear and inconsistent. For example, one Brighton AESI is enteritis/colitis, for which the corresponding adverse events would be diarrhea and vomiting. However, the authors included diarrhea but not vomiting when counting relevant SAEs. Another example is the authors’ inclusion of arthritis as a serious adverse event, but not osteoarthritis (a form of arthritis).
The authors also excluded “events related to COVID-19”. While this exclusion could make sense when focusing on potential side effects of the COVID-19 vaccines, it introduces an important bias by eliminating adverse events that are expected to be much more common in the control group than in the vaccinated group. This means that the study was less able to detect harms from COVID-19. Overall, these observations suggest that the adverse events that the authors chose to analyze were the result of cherry-picking.
Second, the authors compared the people hospitalized with COVID-19 with the total number of adverse events in the control and the vaccinated groups rather than the number of individuals who reported the adverse events. Since one person can suffer multiple adverse events but only one hospitalization, this analysis leads to an overcounting of adverse events and over-represents the harmful effects of vaccination compared to the risks of COVID-19. For example, a person who reported colitis, diarrhea, and abdominal pain, would be counted as three adverse events, even though the three occurred in the same person and are likely related.
Finally, some of the included adverse events, such as diarrhea, abdominal pain, and rash, aren’t equivalent to a COVID-19 hospitalization in terms of disease severity. This analysis also doesn’t take into account the benefits of vaccination in preventing COVID-19 complications other than hospitalization, including cardiovascular problems.
Given the methodological flaws in the study, the analysis is unreliable and doesn’t support the claim that vaccines cause more serious adverse events than the benefits they provide.