by Barbara Gehrett, MD; Joseph Gehrett, MD; Chris Flowers, MD; and Loree Britt, Daily Clout:
By late February 2021, a group of experts called Brighton Collaboration released a paper, which was published in Vaccine, clearly defining Vaccine-Associated Enhanced Disease (VAED), which is a more severe clinical presentation of a disease in a person vaccinated against that disease than would normally be seen in an unvaccinated person. Yet, Pfizer, public health, and media spokespeople only referred to post-COVID-vaccination COVID-19 infections as “breakthrough cases” — i.e., normal, not more severe, COVID infections — without explaining the possibility of VAED in such cases. Not explaining VAED kept the public in the dark about how receiving initial and additional COVID vaccine doses may cause worse COVID illness than remaining unvaccinated.
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Public health entities, the medical community, and media constantly assured the public that the COVID-19 mRNA shots were “safe and effective;” yet, during the first three months of the Pfizer’s public vaccine rollout, Pfizer was informed about thousands of cases of post-vaccination COVID-19 as covered by WarRoom/DailyClout researchers in Report 90. Those COVID cases are very important, because contracting COVID post-vaccination opens the door to suffering VAED or Vaccine-Associated Enhanced Respiratory Disease (VAERD), which is “disease with predominant involvement of the lower respiratory tract.” [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901381/] In other words, getting a COVID vaccine opened the door to vaccinated individuals getting more serious COVID illness than they may have experienced if they remained unvaccinated. Despite Table 5 of Pfizer’s document ‘5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021’ (a.k.a., “5.3.6“) stating, “No post-authorized AE [adverse event] reports have been identified as cases of VAED/VAERD, therefore, there is no observed data at this time,” the actual data in Pfizer’s post-marketing report paint a very different picture showing that thousands of the COVID cases and COVID-related serious adverse events (SAEs) appear to qualify as VAED or VAERD.
As Pfizer received post-marketing surveillance reports in December 2020 and early 2021, it knew its COVID vaccine was not stopping people from contracting COVID. In the VAED/VAERD table on page 11 of 5.3.6, 138 patients had 317 “relevant events,”, i.e., conditions or diseases, which included 101 confirmed and 37 suspected COVID-19 cases. Pfizer categorized all 138 cases, including 38 deaths, as ‘serious.’ The company stated that, of the subjects with confirmed COVID-19, “75 of the 101 cases were severe, resulting in hospitalization, disability, life-threatening consequences or death.” Seemingly inexplicably, Pfizer went on to conclude, “None of the 75 cases could be definitively considered as VAED/VAERD. In this review of subjects with COVID-19 following vaccination, based on the current evidence, VAED/VAERD remains a theoretical risk for the vaccine. Surveillance will continue.” In light of that, the definition of VAED and the different diagnostic levels of the condition, as defined by the Brighton Collaboration experts, becomes critically important.
In March 2020, the Brighton Collaboration gathered to define VAED. The group concluded that it is “difficult to separate vaccine failure (also called breakthrough disease) from VAED in vaccinated individuals. All cases of vaccine failure should be investigated for VAED.” [Bold and italics added.] Despite this expert recommendation, the FDA, Centers for Disease Control and Prevention (CDC), and other public health spokespeople told the public that COVID infections after vaccination were “breakthrough” cases and did not mention VAED or VAERD as possibilities. The Brighton authors also asserted, “VAED always involves a memory response primed by vaccination and, in the experiences best characterized until now, targets the same organs as wild-type infections.” [Bold added.] They concluded, “The broad spectrum of natural disease manifestations in different populations and age groups makes it very difficult, if not impossible, to determine how severe COVID-19 infection would have been in the absence of vaccination in the individual case.” (Italics in the original, bold added.) However, the Brighton Collaboration provide a means to make such a determination easier.
The Brighton experts wrote, “Identifying cases of VAED/VAERD might be impossible when assessing individual patients, however, in clinical studies, a control group is helpful to compare the frequency of cases and the severity of illness in vaccinees vs. controls, including the occurrence of specific events of concern such as hospitalization and mortality.” (Bold added.) Unfortunately, and perhaps conveniently, Pfizer quickly eliminated its clinical trial control group. Pfizer’s Phase 2/3 randomized controlled clinical trial started in July 2020 with a vaccinated group and a placebo (unvaccinated) group, both of which were to be followed for two years. However, in December 2020, when the Food and Drug Administration (FDA) granted emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine, Pfizer asked for and received permission from the FDA to ‘unblind’ the study — meaning, to offer the vaccine to the placebo participants. Most of placebo group accepted the offer and were vaccinated by March 2021, at which time the control group ceased to exist.
When Pfizer concluded on page 11 of 5.3.6, “None of the 75 cases could be definitively considered as VAED/VAERD,” the company appeared to be referencing Brighton Collaboration’s “Level 1 of Diagnostic Certainty (Definitive Case)” – i.e., “The working group considers that a Definitive Case (LOC 1) of VAED cannot be ascertained with current knowledge of the mechanisms of pathogenesis of VAED.” [Italics added.] However, Brighton Collaboration defined multiple levels of diagnostic certainty, including LEVEL 3B:
“A possible case of VAED is defined by the occurrence of disease in vaccinated individual with no prior history of infection and unknown serostatus, with:
Laboratory confirmed infection with the pathogen targeted by the vaccine
AND
Clinical findings of disease involving one or more organ systems (a case of VAERD if the lung is the primarily affected organ)
AND
Severe disease as evaluated by a clinical severity index/score (systemic in VAED or specific to the lungs in VAERD)
AND
Increased frequency of severe outcomes (including severe disease, hospitalization and mortality) when compared to a non-vaccinated population (control group or background rates)
AND
No identified alternative etiology.” [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901381/table/t0025/?report=objectonly]
The aforementioned 75 cases of severe COVID to which Pfizer admits fit the Level 3B criteria for possible VAED and should not have been dismissed because they did not fit the impossible to ascertain ‘Level 1’ VAED definition. Pfizer failed to do due diligence when it did not investigate the 75 cases for VAED, yet that was just the tip of the iceberg of cases needing investigation.
