Reanalysis Of The AstraZeneca Trials
Reanalysis Of The AstraZeneca Trials
Breaking down all the HART Group's key findings
Compared to Pfizer and Moderna, the AstraZeneca trial data seems to have attracted little attention.
This is somewhat surprising given their product was the first to be halted by several countries in early 2021 over fears of blood clots.
Currently, for AstraZeneca’s jab, the Yellow Card Self-Reporting System has nearly a quarter of million adverse events logged. That is just in the UK, where King Charles also happened to knight CEO Pascal Soriot last year in December.
So what did the likely spied-on doctors over at the HART Group find in their reanalysis?
The Principle of “Intention To Treat”
Understanding how AstraZeneca arrived at their results involves a concept called "intention to treat." This means analysing outcomes based on the original groups people were put in, regardless of what happened afterward.
AstraZeneca decimated this principle when they excluded infections in the “vaccinated” group recorded within the first 2 weeks post-injection.
Phase 1 and 2 - Safety Analysis and Efficacy
Their first trial in Rhesus monkeys failed to reduce infection rates and the amount of virus produced. But human trials went on.
Two trials were then conducted, one in the UK and one in South Africa.
In the UK trial, initially, the plan was to conduct a trial with two groups, 1b and 2b, receiving a saline placebo. However, within a week, this changed to using a meningococcal vaccine. By April 20th 2020, the term "placebo controlled" was removed entirely.
The trial plan underwent more adjustments. It was originally set to end in May 2021 with 6 months of follow-up and an optional one-year follow-up. But by September 2020, the follow-up duration extended to 15 months from enrolment, and the end date shifted to October 2021. This was not for enhanced safety monitoring.
Updated protocols specified that serious adverse events would be tracked "until a cutoff date of 1st July 2021 or 6 months post late vaccination visit, whichever is latest." Yet, this 6-month follow-up only applied to specific adverse events listed in their questionnaire, like pain, redness, fever, etc.
An updated trial plan, however, further reduced follow-ups for certain groups, stating "occurrence of unsolicited adverse events (AEs) for 28 days following vaccination (7 days following vaccination for groups 1c, 1d, 5a & 5b)." They didn’t make clear why.
Results from UK Phase 1 and 2
The trial conducted between April 23rd and May 21st, 2020, documented ugly results. Patients with severe COVID-19 were shown to have significantly higher antibody levels compared to those who received a single dose or two doses.
Their primary focus was to look at PCR positive symptomatic Covid cases and serious adverse events. Interestingly, of the 1077 participants monitored, they never disclosed the number of PCR positive cases, only presenting data combined from other trials.
Results from South Africa Phase 1 and 2
Roughly a month after the UK 1/2 trial concluded, the phase 1/2 trial began in South Africa during the first wave of Covid. They recruited 2,070 participants from June 24th to November 9th, 2020. The placebo used in this trial was saline, and the follow-up period was around 22 weeks before interim results were published.
But once again, there are gaps in the data. For instance, AstraZeneca show the cumulative count of PCR positive Covid cases after the second “vaccine” dose but show nothing of the positive or negative cases between the first and second dose.
Nevertheless, the results showed a total of 23 "cases" among the placebo group and 19 "cases" among the “vaccine” group. No severe cases or hospitalisations were reported. The underperformance of the vaccine was attributed solely to the presence of the Beta variant circulating in South Africa at the time.
HART suggest that in regular circumstances, these results should have halted plans for a phase 3 trial. They also note that the same AstraZeneca team started a vaccine trial for children before they had gathered enough safety data from adult trials.
Phase 3
In another frankly staggering revelation, phase 3 trials were then initiated before phase 2 or 1 had fully concluded.
They expanded trials both to Brazil and more extensively in the UK, with total enrolment nearing 24,000 participants. Brazil contributed a little over 10,000 more participants starting from June 2020, while an additional 10,000 were included from the UK.
Interim Results
On December 8th 2020, the researchers published interim results, prompting temporary authorisation and rollout.
They considered all 23,848 participants for safety aspects, but focused only on 11,636 participants to evaluate efficacy. Researchers omitted all participants from South Africa in their efficacy calculations.
In short, they only included 48% of the participants monitored, which the HART Group argue reduces the sample size to such an extent that it compromises the chance of finding a “meaningful result”.
They continue:
In the main analysis there were 30 covid 'cases' in the vaccine group and 101 in the placebo group making for an efficacy of 70%. In other words, 82 people had to be vaccinated to prevent a single 'case' more than two weeks after the second dose. For the participants that received a standard dose there were 27 cases out of 4440 in the vaccine group and 71 out of 4455 in the control group giving an efficacy of 62%. If the South African cohort had been included the efficacy would have been 51% - only 1% above the WHO baseline for approval of vaccines.
AstraZeneca also altered the timescales for monitoring severe disease and death. As noted earlier, for infection efficacy, they excluded those jabbed within 2 weeks. For severe disease and death, they excluded those jabbed within 3 weeks. Using these altered scales, they counted 2 severe disease cases and 1 death in the placebo arm and 0 in the vaccinated, manufacturing a 100% against severe disease and death claim.
You can find analysis of the final trial results here:
In summary, the HART Group’s lengthy analysis of the AstraZeneca trials highlights several concerns regarding design, reporting, and result interpretation.
AstraZeneca did not possess enough real-world evidence to back up their efficacy claims, there are sizeable periods of data absence, and the lack of a saline control in the UK trials raises questions.
The worst finding, however, has to be the incredibly short adverse event follow-up duration set in phase 1/2 trials. That and the fact that they only seemed to look out for mild symptoms.
In fact, the first time AstraZeneca noticed severe adverse events was in July 2020 when a patient developed multiple sclerosis and the second time when a participant developed transverse myelitis.
Despite this, the study they planned to look at these safety issues was cancelled the same month the transverse myelitis adverse event was reported.
Rest in peace mother-of-one Lisa Shaw, 44, who died from 'vaccine-induced thrombotic thrombocytopenia' in May 2021, about a week after receiving her first AstraZeneca dose. She worked for BBC Radio Newcastle.
Lawyers for her husband, Gareth Eve (pictured left), reportedly sent pre-action protocol letters to AstraZeneca last year on the behalf of nearly 75 people who allege that their relatives died or suffered injuries related to the vaccine.
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