Were there more covid deaths in the vaccine group in the Pfizer/BioNTech trial?

Reanalysis shows huge numbers of discrepancies

Dr Clare Craig

Dr David White is a retired General Practitioner who has been meticulously examining the Pfizer/BioNTech regulatory submissions and trial publications. In June 2024, he made a video recording all the cardiovascular deaths in trial participants and found that these were 66% higher in the vaccinated than the placebo group (10 vs 6 deaths).

Earlier this year, he produced another video, after a detailed investigation of all the deaths recorded in the Pfizer/BioNTech covid vaccine trial. He covers many points in the video and I want to highlight a key point around the designation of deaths as covid related.

The pharmaceutical companies contradicted themselves in their regulatory submissions and their peer review publications as to how many dead participants had covid.

They themselves said not all placebo deaths recorded as covid in their submission reached the criteria for a covid death. The FDA submission on 23 August 2021, mentions seven deaths “due to COVID-19” but goes on to say that

“Seven deaths were due to COVID-19 (1 BNT162b2 recipient and 6 placebo recipients). Each case had a positive COVID test…, but not all tests…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 New England Journal of Medicine (NEJM) publication on 15 September 2021, which concurred that the total deaths were 15 in the vaccine group and 14 in the placebo group, only mentioned 1 vaccinated and 2 placebo deaths attributed to covid.

Dr White asks the important questions as to what impression the regulators were left with having been presented with a table that showed an apparent six covid related deaths in the placebo group compared to only one in the vaccine group. Did that affect their later judgement on risk benefit analysis as safety issues emerged?

This is what the regulators were presented with:

Figure 1: Tables from regulatory submission on 23 August 2021

The number of deaths labelled as “covid” in the placebo group is strikingly more than in the vaccine group.

After careful analysis Dr White removed deaths that occurred in the post blinding period or were in participants that should have been excluded.

Placebo group

Let’s flesh out each of these deaths starting with the placebo group - working from the top down.

Participants 1-2

Both these participants died after unblinding so are not in the blinded placebo controlled part of the trial.

Participant 3 had a non-covid attributed death.

Participant 4 died after unblinding - 10271191

This was a 68 year old female who was unblinded on 6 January 2021. She declined the vaccine and was diagnosed with hypoxic respiratory failure on 12 Jan 2021. This is a clear example of the healthy vaccinee effect leaving the dying in the unvaccinated group.

Participants 5 and 6 had non-covid attributed deaths.

Participant 7 received unauthorized Moderna vaccine 10841470

This individual was initially in the placebo group but independently obtained a Moderna vaccine outside of the trial protocol. Note the “+” sign next to the seventh entry on the placebo table leading to a footnote in a particularly small font. After receiving the Moderna dose, the participant died of covid 19 days later. The protocol prohibited out of trial covid vaccines and 388 were indeed discontinued for this reason.

Participant 8 NEJM reported cause as cardiac arrest, reclassified as covid in FDA submission 10881126

The eighth participant in the placebo death table was originally listed in the NEJM publication as “cardiac arrest,” yet the FDA Table 32 reclassified it as a “COVID-19 death.” No explanation for this reclassification was provided but the narrative report says, “The death certificate indicated the cause of death as cardiac arrest due to progression of coronary artery disease, hypertension, and COVID-19”. The discrepancy raises concerns about retrospective changes to causality that could affect the perceived benefit of vaccination.

Participant 9 - had a non-covid attributed death

Participant 10 - was a placebo covid death

Participant 11 - died of a test negative pneumonia 11281009

HART has previously reported on bad record keeping in the trial related to a placebo patient who died of pneumonia with no positive PCR result. This write up was based on Case Review File (CRF) entries. A “potential covid illness” form was completed on the basis of cough and shortness of breath. After death it was removed because death had already been recorded. The narrative report states he was admitted with a myocardial infarction (MI) due to a failed stent which was replaced. He had postoperative pneumonia. Antibiotics were started but he discharged himself. Eventually, the trial site phoned his wife to learn of his death and she stated that he had a negative covid test in the hospital.

Participants 12-15 were non-covid attributed deaths.

Participant 16 not in safety population (e.g. HIV+) 12291083

The sixteenth participant in the placebo table above has an up arrow next to their entry leading to a footnote. This HIV positive placebo participant has previously been reported as having been ineligible with a claim that this death should have been excluded on the basis that the viral load needed to be less than 50 copies per ml. Prior to enrollment on 2 October 2020, the participant had a viral load <50 recorded in August 2020. However, the CRF clearly records (page 515) that the viral load was 50 on 9 October 2020 making them ineligible. That day a request was made to either correct this or complete a “protocol deviation form”. This entry was described as a “transcription error” on 16 October 2020 such that the participant would remain eligible (see figure 2). Either way, being HIV positive meant they should have been excluded from the trial’s formal “safety population” due to protocol-defined criteria.

Table S1 in the supplementary appendix indicates that 200 HIV positive participants were not part of the safety population. This exclusion is confirmed in footnote ‘a’ of 2 tables in protocol sections 1.1 and 3.2. They were excluded from the NEJM table of deaths which said it included the safety population. The FDA submission table states that it was based on “the safety population” but this includes two deaths of HIV participants.

Figure 2: Case Report File for HIV positive participant 12291083

Participants 17 and 18 had non-covid attributed deaths.

Participant 19. NEJM reported cause as multiple organ failure, reclassified as covid 12315324

The nineteenth entry in the placebo death table was attributed to “multiple organ failure” in NEJM Table S4 but was re-labeled “COVID-19” in the FDA documentation. There was no justification offered for the cause-of-death reclassification, and the lack of transparency contributes to doubts about the data’s consistency and reliability.

Removing these four ineligible deaths leaves one with covid as the underlying cause and 1 with covid as a contributory cause (in addition to progression of coronary artery disease and hypertension, and which is contradicted in NEJM)

Vaccine group deaths

Let us now turn to the vaccine group. There were two deaths in the vaccine group worth looking at in more detail.

Participant 7 of vaccine group: Death from respiratory disease but no symptoms or test results were recorded

10891073 was a 63 year old woman with “stable chronic lung disease” who received dose 1 on 6 August 2020 and dose 2 on 4 September 2020.

2 October 2020

• attended site and did not have any symptoms. No mention of breathing difficulty or cough.

12 November 2020

• died of “worsening COPD”. The report stated “relevant tests were unknown” and, again, no autopsy was performed. No mention was made as to what the death certificate said.

• The death was recorded as “toxicity grade 4” rather than grade 5.

There is no mention of what happened between her being perfectly well on 2 October 2020 and dying. No symptoms were recorded. No testing was done.

A participant dying of a respiratory disease without having a covid test recorded at all is questionable.

Note how the term “covid negative” appears twice in the table such that at a glance the word covid is mentioned many times among the placebo deaths. For fairness this case should at least have been recorded as “covid test absent”.

Participant 15 of vaccine group: Antibody positive covid infection and death shortly afterwards attributed to cardiac arrest

Subject 11401117 was a 58-year-old male who received Dose 1 of the investigational product on 14 August 2020, and Dose 2 on 4 September 2020. The narrative report (page 105) gives a different timing and sequence of events to the CRF. Narrative report and table 32 state “sniffles” and no mention of cough which started on 7 December 2020. Positive antibodies were recorded on an unspecified date.

The following entries are included in the case report file.

30 October 2020

• he reported symptoms of new cough and nasal congestion.
  telemedicine consultation

1 November 2020

• a self-collected nasal swab for PCR testing was documented.
  No test result for this swab was recorded in the clinical trial database.

7 December 2020

• labeled as a “convalescent visit”, implying symptom resolution.
  However, the audit trail contradicts this, with an entry on December 8 stating: “Subject confirmed symptoms are still ongoing.”

• a serum sample for covid antibodies was collected.
  This later returned as positive, but it is not known whether this was vaccine spike antibodies only or included N antibodies indicative of recent infection. The MHRA in response to an FOI say they do not have this data.

28 December 2020

• the subject suffered a sudden cardiac arrest and died at home.
  No autopsy was performed.

• the event was recorded as “toxicity grade 4”, which denotes life-threatening illness. Death should be recorded as grade 5.

Despite confirmed covid infection, persistent symptoms, and death, covid was not mentioned in the trial’s cause of death report, and the event was attributed to pre-existing medical conditions.

At the end of this reanalysis we are left with one acknowledged, but possibly two or three covid related deaths in the vaccine arm (7, 15 and 19 in the table above) but only one in the placebo group (10) plus one with covid mentioned as a contributory factor (8).

After excluding the ineligible deaths, the analysis could have been presented like this.

All this forensic work has been carried out by a retired doctor in his own time, work for which the MHRA are paid, as are the health and science editors of the legacy media.

Had the deaths been fairly reported from the outset would the regulators have been as enthusiastic as they were - breaking their own rules to promote the vaccines as Safe and Effective. Would politicians and the public have taken a more balanced view of what a vaccine could possibly achieve? Would people still be as convinced as some are that they were ‘saved’ by a vaccine rollout?