The U.S. Food and Drug Administration’s (FDA) advisory committee has endorsed Pfizer’s COVID vaccine for children ages 5 to 11, despite strong objections raised during the meeting by multiple scientists and physicians.
During today’s meeting, the Vaccines and Related Biological Products Committee (VRBPAC) heard evidence from Pfizer and regulators, and listened to concerns from numerous experts.
Based on CDC data presented during the meeting, among children 5 to 12 years of age, there have been approximately 1.8 million confirmed and reported COVID cases since the beginning of the pandemic, and only 143 COVID-related deaths in the U.S. through Oct. 14.
Experts raised concerns over the lack of safety and efficacy data presented by Pfizer for use of its COVID vaccine in younger children, and they pointed to increasing safety signals based on reports to the Vaccine Adverse Event Reporting System (VAERS).
They also questioned the need to vaccinate children — whose risk of dying from COVID is “almost nil” — at all.
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According to Dr. Meryl Nass, member of the Children’s Health Defense Scientific Advisory Panel, Pfizer once again did not use all of the children who participated in the trial in their safety study.
“Three thousand children received Pfizer’s COVID vaccine, but only 750 children were selectively included in the company’s safety analysis,” Nass said. “Studies in the 5-11 age group are essentially the same as the 12-15 group — in other words, equally brief and unsatisfying, with inadequate safety data and efficacy data, with no strong support for why this type of immuno-bridging analysis is sufficient.”
During the meeting and in its FDA application, Pfizer argued children should be vaccinated to prevent SARS-CoV-2 transmission, yet the company did not assess asymptomatic transmission.
Dr. Ofer Levy, a VRBPAC member, asked for evidence that Pfizer’s vaccine prevents transmission.
Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not assess whether the vaccine prevents transmission, but said there is evidence the vaccine prevents transmission in adults.
Steve Kirsch, founder of the COVID-19 Early Treatment Fund, asked the panel how they could do a risk-benefit analysis with Pfizer’s COVID vaccine if they did not know the CDC’s VAERS under-reporting factor (URF).
Kirsch also questioned the panel on why Maddie de Garay’s severe adverse reaction to the Pfizer vaccine, which left her paralyzed, was not reported by the company to the FDA.
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In a peer-reviewed study co-authored by Rose, myocarditis rates were significantly higher in people 13 to 23 years old within eight weeks of the COVID vaccine rollout.
In 12- to15-year-olds, Rose said, reported cases of myocarditis were 19 times higher than background rates.
Guetzkow said, “from CDC reports, we can expect that for every 18 child hospitalizations prevented, at least 43 will end up in the hospital for all causes following vaccination,” yet, the “FDA’s risk-benefit analysis only counts myocarditis hospitalization.”
There are more than 900 types of adverse events reported after Pfizer vaccination that have never been reported after flu vaccines, including 11 cases of multisystem-inflammatory syndrome (MS-C) that occurred without previous history of COVID infection, Guetzkow said.