Ignored danger signals

Sudden deaths in the Pfizer/BioNTech trial

As a result of the Texan court ruling that the FDA had to release the documents which led to authorisation of the Pfizer/BioNTech vaccine, there continue to be more revelations.

The publication of the trial results that led to initial approvals claimed there had been four deaths in the placebo group and only two in the vaccination group. By the time of the publication of the 6 month follow up data the ratio was 15 in the vaccination group and 14 in the placebo group. However, this was not the full story and more evidence emerged subsequently.

Following the deadline for data submission, reporting of deaths among placebo recipients occurred with a median of 3 days, while in the vaccination group, the median time was 7 days. Before this cut-off, the median time to report a death for placebo recipients was 5 days, but it extended to 18 days for those who received the vaccination. This disparity suggests there were two biases. One bias is between the placebo and vaccine group which should not happen in a blinded study. The second bias is between the period before and after the first data submission which led to authorisation.

Data submitted to the FDA on 18th May 2021 gives a fuller picture of deaths up to the point of unblinding, including approximately 6 months of follow up.

The data included all deaths up to 13th March 2021 but there were two deaths of patients who had taken two doses of placebo and then a dose of vaccine. These deaths have been excluded from this analysis. 

It is not totally straightforward to take the remaining data at face value. For instance, there was a 65-year-old man from Texas who had received two placebo injections and then got the Moderna vaccine while still in the trial. He developed COVID-19 during the critical post-vaccination period, was hospitalised within a week of receiving the vaccine, and passed away 11 days post-injection. His death was categorised as an unvaccinated COVID-19 death in the trial findings.

Nor were deaths properly investigated. Another case involved a 60-year-old man who received the vaccine on September 10th was found deceased in his home by police on September 13th, after concerns were raised about his lack of communication. His death, however, wasn’t recorded in the study data until November 22nd, which was a week past the data submission deadline that informed the trial's conclusive report leading to its approval. Despite a two-months passing after his death, the report said, "Autopsy results were not available at the time of this report."

There is a discrepancy between the text in the document and the table. Although the text says, “From Dose 1 to the data cutoff (March 13, 2021), there were a total of 38 deaths among participants >16 years of age (19 BNT162b2 recipients, 2 Placebo/BNT162b2 recipients and 17 placebo recipients)” the table shows 22 deaths in the vaccine group (including the two placebo then vaccine recipients) and 16 in the placebo group. 

Details are provided for 20 of the deaths in the vaccinated (once those injected after the original placebo group are excluded) and 16 in the placebo group. Taking a closer look at these there is a clear difference in the number of sudden, unexplained deaths.

Figure 1: Deaths in the vaccine and placebo group with sudden, unexplained deaths highlighted in yellow (N.B. two deaths are included in this table of placebo participants who were unblinded and had vaccine before dying).

Taking a closer look there is a notable difference in timing of these sudden, unexplained deaths. While there were equal numbers in the first two months, thereafter there were 5 in the vaccine group and only 1 in the placebo group.

Table 1: Difference in timing of sudden, unexplained deaths

An astonishing 6 out of 16 deaths in the placebo group were attributed to covid. There was nowhere in 2020 where, over a 6 month period, 38% of deaths were attributed to covid. The second quarter of 2020, which had the highest covid attributed deaths pre-vaccine, had only 26% of deaths attributed to covid. These covid attributed deaths did not impact on all cause mortality. The FDA submission shows that those writing the reports did not consider these deaths significant enough to include in the efficacy calculation "Seven deaths were due to COVID-19 (1 BNT162b2 recipient and 6 placebo recipients). Each case had a positive COVID test (PCR or NAAT), but not all tests (including the positive PCR in the case of fatal COVID-19 pneumonia reported 109 days after Dose 2 of BNT162b2) were within the specifications of the study protocol for tests with acceptable sensitivity and specificity and were therefore not included in protocol-specified efficacy analyses of severe COVID-19 cases."

In contrast, the additional sudden deaths with no underlying cause did impact on overall mortality and the extra 4 sudden and unexplained deaths in the vaccine group were reflected as an extra 4 deaths overall in that group:

An extra 4 deaths amounts to a risk of 1 in 5,500 people injected. This is a red flag that the regulators should have been highly concerned by. It is worth noting that if there had been 13 extra deaths in the vaccinated group making 29 altogether compared to 16 in the placbo group it would still not reach statistical significance. Only 30 deaths, almost double the mortality rate would have been enough to do that.

The purpose of randomised controlled trials is to make comparisons such as these. At the time of this report in May 2021, it was already clear that there was an unexpected rise in cardiac arrest calls to ambulances in England. Not only were all these alerts ignored at the time they have continued to be ignored ever since despite increasing evidence that there is a risk of sudden cardiac death associated with these novel drugs.