Brian Dressen, Ph.D., who is a chemist with an extensive background in researching and assessing the degree of efficacy in new technologies, told the U.S. Food and Drug Administration Pfizer’s vaccine “failed any reasonable risk-benefit calculus in connection with children.”
The U.S. Food and Drug Administration’s (FDA) advisory committee on Tuesday endorsed Pfizer’s COVID vaccine for children ages 5 to 11, despite strong objections raised during the meeting by multiple scientists and physicians.
Brian Dressen, Ph.D., is one of the scientists who testified during the 8-hour hearing.
Dressen is also the husband of Brianne Dressen, who developed a severe neurological injury during the Utah-based portion of the U.S. AstraZeneca COVID vaccine trial in 2020. After being injured by the first dose, Brianne withdrew from the trial.
During his 3-minute testimony, Dressen, a chemist with an extensive background in researching and assessing the degree of efficacy in new technologies, told the FDA advisory panel Pfizer’s vaccine “failed any reasonable risk-benefit calculus in connection with children.”
Dressen said:
“Your decision is being rushed, based on incomplete data from underpowered trials, insufficient to predict rates of severe and long-lasting adverse reactions. I urge the committee to reject the EUA [Emergency Use Authorization] modification and direct Pfizer to perform trials that will decisively demonstrate that the benefits outweigh the risks for children. I understand firsthand the impact that you will or will not have with the decision you’re going to make today.”
Dressen told the FDA how his wife was severely injured last November by a single dose of a COVID vaccine administered during a clinical trial. He said:
“Because study protocol requires two doses, she was dropped from the trial, and her access to the study app deleted. Her reaction is not described in the recently released clinical trial report — 266 participants are described as having an adverse event leading to discontinuation, with 56 neurological reactions tallied.”
He said he and his wife have since met participants from other vaccination trials — including Pfizer’s trial for 12- to 15-year-olds — who suffered similar reactions and fate.
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