Sudden Deaths Twice as High in Vaccine Group than Placebo Group in Pfizer Trial, Researchers Say
New analysis of the original Pfizer clinical trial data has revealed that the incidence of sudden deaths was twice as high in the vaccine group compared to the placebo group.
Researchers from the Health Advisory and Recovery Team (HART) found four additional sudden deaths in the vaccine group, all occurring after the first 60 days, reigniting concerns about the safety of the mRNA vaccine.
The total number of sudden deaths with no underlying cause was 12, with eight in the vaccine group and four in the placebo group. Notably, the four additional sudden deaths in the vaccine group accounted for the entire difference in the total number of deaths between the two groups – 20 in the vaccine group and 16 in the placebo group.
Concerningly, these findings challenge the common assumption that vaccine-related harms would manifest within the first 28 days of vaccination, as the additional sudden deaths occurred after the initial 60-day period. This timeline raises questions about the adequacy of safety assessments that predominantly focus on the initial weeks post-vaccination.
Despite the alarming nature of these results, the researchers emphasize that the relatively small sample size prevents statistical significance, as the trial involved 44,000 participants. Nonetheless, if extrapolated to the wider population, this rate of death would translate to a vaccine mortality rate of approximately one per 5,000 people, potentially leading to 10,000 deaths in the UK. The researchers stress the importance of not ignoring such signals, even if they fall below the conventional significance threshold, calling for further investigation to either confirm or rule out the associated risks.
The analysis also revealed potential biases and issues with the trial’s blinding process. The average time taken to report deaths in the vaccine group was two to three times longer than in the placebo group, raising concerns about the integrity of the blinding protocol. Notably, longer delays in reporting vaccine-group deaths occurred before the critical interim report, which served as the basis for emergency approval.
The HART researchers also pointed out questionable classification decisions, such as categorizing a 65-year-old man’s death as unvaccinated after receiving the Moderna vaccine due to unblinding. These biases, seemingly favoring the vaccine, underscore the importance of interpreting harm estimates as a lower bound.
The revelation that sudden deaths were twice as high in the vaccine group adds to the growing concerns surrounding the safety of mRNA vaccines and raises questions about the oversight and regulatory response to such critical findings.
