SALT LAKE CITY (KUTV) — COVID-19 vaccines for children ages 5-11 in the U.S. are one step closer to approval after a unanimous vote from a Food and Drug Administration advisory panel, with one abstention.
The group voting Tuesday said the vaccine’s benefits in preventing COVID-19 in that age group outweigh potential risks.
During the eight-hour hearing, doctors, scientists and concerned citizens were given a chance to testify.
Dr. Brian Dressen, Ph.D., is a Utah father, husband and chemist who testified before the panel.
Each of you hold a significant responsibility today and know that without a doubt, when you approve this for the 5-11-year-old’s, you are signing innocent kids and uninformed parents to a fate that will undoubtedly rob some of them of their life,” he said.
Dressen’s wife Brianne took part in the Utah-based portion of the U.S. AstraZeneca trial in 2020. She suffered significant neurological injury after the first dose and withdrew from the trial. She spoke to KUTV News reporter Jim Spiewak Tuesday, saying her kids will not receive a COVID-19 vaccine, if approved.
Dressen told the FDA advisory panel their “decision is being rushed, based on incomplete data from underpowered trials, insufficient to predict rates of severe and long-lasting adverse reactions.”
He urged the committee to reject the EUA modification and direct Pfizer to perform trials “that will decisively demonstrate that the benefits outweigh the risks for children.”
In his brief three-minute testimony, Dressen shared his wife’s story:
My wife was severely neurologically injured by a single COVID vaccine in a clinical trial here in the United States last November. Because study protocol requires two doses, she was dropped from the trial, her access the study app deleted. Her reaction is not described in the recently released clinical trial report. 266 participants are described as having an AE leading to discontinuation, 56 neurological reactions are tallied.
Since his wife’s vaccine injury was diagnosed by doctors at the National Institutes of Health, the Dressens have met with other trial participants and families with children who also believe they were injured by the COVID-19 vaccines.
They have formed a support group for those with vaccine injuries, a group that still largely backs vaccines. The website C19 Vax Reactions shares stories of vaccine injury, including Utah mom Cherie Romney.
Romney's son Everest is a junior at Corner Canyon High School in Draper, Utah. Everest played basketball as an “elite athlete” in his sophomore year until he received the first Pfizer vaccine April 21.
Romney said her son, who is now 17, immediately experienced swelling after the vaccine and within days could not move his head. He was dismissed by doctors, including his own pediatrician.
Nine days later, the 16-year-old boy was hospitalized with three blood clots, two of which were on his brain, one on his jugular.
Romney spoke out on the experience of her son, a junior at Corner Canyon High School in Draper.
This group of vaccine-injured people has pushed the FDA and the Centers for Disease Control and Prevention for answers and help. Largely ignored, they reached out to Utah Senator Mike Lee, who wrote to the CDC and FDA on their behalf.
Dressen addressed the dismissal in his testimony Tuesday, saying “the FDA has known first-hand about her case and thousands of others, the FDA has also stated that their own safety systems are not identifying this issue and that VAERS is not designed to identify any multi-symptom signals. The system is broken.”
My family’s life has changed forever," he added. "The clinical trials are not appropriately evaluating the data, the FDA, CDC and drug companies continue to deflect the persistent and repeated cries for help and acknowledgement, leaving the injured as collateral damage.
You can listen to Dressen’s full testimony to the FDA panel here:
As of Oct. 21, nearly 6.3 million children have tested positive for COVID-19 since the onset of the pandemic. The American Academy of Pediatrics stated: "At this time, it appears that severe illness due to COVID-19 is uncommon among children.”
Among 45 states reporting mortality, children were 0.00%-0.26% of all COVID-19 deaths, and seven states reported zero child deaths.
The data also showed that in states reporting, 0.00%-0.03% of all child COVID-19 cases resulted in death.
The Pfizer vaccine which was in front of the FDA review panel showed a nearly 91% effectiveness rate at preventing symptomatic infection. You can listen to the full hearing from Oct. 26 with the FDA on YouTube, or below.