Pfizer failed to look into thousands of possible cases of vaccine-associated enhanced disease (VAED), allege some US physicians.
Medical doctors Barbara Gehrett, Joseph Gehrett, Chris Flowers and co-author Loree Britt made their allegations in and . The articles analyze court-mandated disclosures of documents Pfizer submitted to the US Food and Drug Administration.
By February 2021, researchers from the Brighton Collaboration Network had already as a more severe clinical presentation of a disease in a person vaccinated against that disease than would normally be seen in an unvaccinated person.
As that month ended, Pfizer released a post-marketing report showing 2,585 “serious” COVID-related adverse events in those who received the vaccine.
The report showed 136 of these patients died. Half of COVID-related adverse events began within five days of injection and 77% constituted COVID-19 infections. Two infants and one child were among those who reported adverse events, even though those under age 12 had not yet been approved for the vaccine.
In one report, Pfizer identified 138 patients with 317 “relevant” adverse events. Of these, 101 were confirmed to have COVID-19 and 37 suspected to have it. “[Seventy-five] of the 101 cases were severe, resulting in hospitalization, disability, life-threatening consequences of death,” Pfizer reported. “None of the 75 cases could be definitively considered as VAED.”
In their February 2021 scholarly paper, the Brighton authors clarified how proof of VAED could best be established.
“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.”
The problem was Pfizer eliminated any chance of that happening.
Pfizer’s Phase 2 and 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, when the Food and Drug Administration (FDA) granted emergency use authorization for Pfizer’s COVID-19 vaccine, that December, Pfizer received permission from the FDA to offer the vaccine to the placebo participants. Most of the placebo group accepted the offer and were vaccinated by March 2021, so the control group ceased to exist.
Regardless, the Brighton group identified a third-tier level of diagnostic certainty which was still available. However, the DailyClout doctors said “Pfizer failed to do due diligence” using this criteria on the 75 cases and 2,391 other ones “suspicious of VAED.”
Some aspects of Pfizer’s post-marketing report were irreconcilable to the DailyClout physicians. For example, the report said the range of onset of COVID-related adverse events ranged between 24 hours and 374 days after the vaccine.
“Pfizer’s post-marketing report covered only the first 90 days of the vaccine availability and the report was received by the FDA in late April; therefore, the maximum range should have been 150 days or less (December 1 2020, through April 30 2021)."
"Given that, how is an onset of 374 days captured in the post-marketing surveillance report? It does not make sense.”
The Pfizer report, labelled 5.3.6 in the list of disclosed documents, also has conflicting statistics on the number of COVID-19 cases in vaccine recipients.
“Table 2 reports 1,927 cases (4.6% of the 42,086 cases); Table 6 reports 2,211 cases (1,665 loss of efficacy cases and 546 COVID-19 cases excluded because they occurred so early after the first vaccine dose); and Table 7 [has] at least 2,391 cases,” the analysts noted.
“Which of those figures is correct? Or should the three be combined? The numbers don’t add up.”
VAED seems neither a concern nor possibility to Health Canada, which still .
“Only vaccines that meet the safety, effectiveness and quality standards of Health Canada are approved for use in Canada. COVID-19 vaccines are tested during their development according to international standards and then carefully reviewed by Health Canada. The benefits of all COVID-19 vaccines continue to outweigh the risks of the disease,” the agency states online.
“The vaccines can't give you COVID-19 because they don't contain the virus that causes it.”