FDA Knew About Numerous Adverse Events For Children ‘Related’ To Pfizer Vaccine, Approved It Anyway

by Patrick Howley | National File

The Food And Drug Administration (FDA) approved an emergency use authorization for the Pfizer-BioNTech vaccine for children as young as 5 years old despite the fact that its Pfizer-connected advisory committee knew about numerous adverse events that were reported in Pfizer’s clinical trials for children, including adverse events that were determined to be “related” to the clinical vaccine trial.

The Briefing Packet for the FDA advisory committee meeting shows that the FDA advisers used clinical studies sponsored by BioNTech and conducted by or supported by Pfizer to approve the vaccine for young children.

VRBPAC-10.26.21-Meeting-Briefing-Document-Sponsor-Pfizer-508-Waiver (1)

Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Document

Source: https://www.fda.gov/media/153409/download

ON PAGE 39 the FDA document states (emphasis added):

Lymphadenopathy is considered an adverse reaction to vaccine and is noted as such in the EUA Fact Sheet. Among approximately 2250 children 5 to <12 years of age randomized 2:1 to receive BNT162b2 or placebo, as of the data cutoff date (06 September 2021), 13 participants (0.9%) in the BNT162b2 group and 1 participant (0.1%) in the placebo group had events of lymphadenopathy.” Lymphadenopathy is a lymph nodes disease. On page 40 the document states that “Lymphadenopathy has been identified as related to BNT162b2 in individuals ≥12 years of age and it is also observed in the pediatric 5 to <12 years of age group.” The document states that “One participant in the BNT162b2 group had a related AE of mild arthralgia (right elbow joint pain), with an onset the same day as Dose 2 (administered in the left deltoid muscle), that was reported as resolved the next day.” The document states that “One participant in the BNT162b2 group had a related AE of moderate paresthesia (bilateral lower extremity tingling) with onset at 1 day post-Dose 2 and reported as recovered/resolved 3 days after onset.” The document states that “In the BNT162b2 group, a psychiatric disorder event of tic was reported in 1 participant: One participant in the BNT162b2 group had an AE of Grade 3 tic with onset at 7 days post Dose 2 and reported as recovering/resolving at the time of the data cutoff. The AE was considered by the investigator as related to study intervention.” The document later notes that “There were 6 participants (0.4%) in the BNT162b2 group and 3 participants (0.4%) in the placebo group had events of lymphadenopathy.”

On PAGE 42 the document states that a trial participant dropped out of the trial due to an Adverse Event, stating “One participant (0.1%) in the BNT162b2 group discontinued from the vaccination period due to an AE (details in Section 3.7.2) and two participants (0.1%) in the BNT162b2 group and 1 participant (0.1%) in the placebo group withdrew from the study before the 1-month post Dose 2 visit. Neither of these withdrawals was reported as due to an AE.”

One participant had blood that passed through his/her anus, which is known as hematochezia, characterized by bloody stool. The document states that “One participant in the BNT162b2 group had a non-serious related AE reported by the investigator as moderate hematochezia 4 days after Dose 2. The participant had heme occult positive stool; was seen in the emergency department, and had no further tests done; and went home and the event resolved the same day without sequelae. This participant had a medical history of asthma and nondrug allergy and had no other reported AEs.”

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