Latest FDA-Pfizer Document Dump: Why Did So Many Participants With ‘Minor’ Adverse Events Withdraw From Trial? By for Children’s Health Defense
July’s release of U.S. Food and Drug Administration documents pertaining to the Emergency Use Authorization granted to the Pfizer-BioNTech COVID-19 vaccine included reports of a significant number of participants who withdrew from the trials — and the reasons for these withdrawals.
July’s release of U.S. Food and Drug Administration (FDA) documents pertaining to the Emergency Use Authorization (EUA) granted to the Pfizer-BioNTech COVID-19 vaccine included reports of a significant number of participants who withdrew from the trials — and the reasons for these withdrawals.
In some instances, participants withdrew or were withdrawn from the trial due to serious adverse events, which again were usually determined to be “not related” to the vaccination.
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In other instances, participants ended their participation in the trial over seemingly minor adverse events, such as injection site pain, without any further explanation provided in the documentation about other factors that may have been at play in the decision to withdraw.
A greater proportion of these minor adverse events were determined to be “related” to the vaccination, as compared to the instances of serious adverse events, which usually were deemed “not related” to the vaccine.
This month’s document cache also reveals a large number of trial participants who contracted COVID-19 during the trial period and a notable revelation regarding the COVID-19 vaccine and pregnant women.
The documents were released on July 1 as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
Public Health and Medical Professionals for Transparency, a group of doctors and public health professionals, submitted the initial FOIA request.
The next 80,000-page cache of FDA documents pertaining to the FDA’s authorization of the vaccine is set to be released on August 1.
Withdrawals from vaccine trials raise more questions than they answer
A total of 34 withdrawals are detailed in a massive 3,611-page “confidential” document with no title — only the file name “fa_interim_narrative_sensitive.”
All participants listed in the document received the 30 μg dose of the BNT162b2 candidate vaccine, which was the one ultimately issued an EUA by the FDA.
Of these 34 withdrawals, four can be identified as being the result of seemingly serious adverse events that were also classified as “related” to the vaccination.
They include:
• A 56-year-old white female in the U.S. (unique subject ID: C4591001 1112 11121118), who was vaccinated with her first dose on Aug. 11, 2020, and discontinued from the study the following day due to generalized pruritus and tachycardia.
She had no ongoing health conditions listed, nor any medical history involving heart conditions. According to the study investigator, “there was a reasonable possibility that the pruritus and tachycardia were related to the study intervention.”
• A 61-year-old Hispanic/Latinο female from the U.S. (unique subject ID: C4591001 1152 11521476) received her first dose of the vaccine on Sept. 25, 2020, but subsequently experienced unilateral deafness on Oct. 14, 2020, and was withdrawn from the trial the following day. Her condition lasted until Oct. 23, 2020.
