umn.edu: https://www.cidrap.umn.edu/covid-19/cidrap-op-ed-manufacturing-scandal-what-fda-s-covid-vaccine-pediatric-death-review

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Subject: J000293
Source: GDELT news · original
Published: Wednesday, May 27, 2026

It is a 73-page consensus review conducted by the career scientists in CBER's Office of Biostatistics and Pharmacovigilance (OBPV), the office responsible for post-market vaccine safety surveillance. It is dated December 5, 2025. It was released last week, attached as an exhibit to a letter Sen Ron Johnson (R-Wisc) sent to Department of Health and Human Services Secretary Robert F.

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CIDRAP Op-Ed: Manufacturing a scandal: What the FDA’s COVID vaccine pediatric death review actually says | CIDRAP Skip to main content Main navigation University of Minnesota http://twin-cities.umn.edu/ 612-625-5000 Go to the U of M home page Main navigation News Antimicrobial Resistance COVID-19 Chronic Wasting Disease Influenza Public Health Alerts All Topics A-Z Coronavirus Vaccines Roadmap Influenza Vaccines Roadmap Roadmaps for Priority Pathogens Vaccine Integrity Project CIDRAP Leadership Forum . . Topics & Projects Antimicrobial Stewardship Chronic Wasting Disease Osterholm Update Podcasts Newsletters About CIDRAP CIDRAP in the News Our Staff Our Director Osterholm in the Press Shop Merchandise Contact Us About Search CLOSE Search Support Menu CIDRAP Op-Ed: Manufacturing a scandal: What the FDA’s COVID vaccine pediatric death review actually says Jake Scott, MD COVID-19 Anti-science MargJohnsonVA / iStock Share Copied to clipboard On the Friday after Thanksgiving 2025, Vinay Prasad, MD, MPH, who was then the director of the Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research (CBER) sent a memo to staff. "For the first time," Prasad wrote , "the US FDA will acknowledge that COVID-19 vaccines have killed American children." He said no fewer than 10 of 96 pediatric deaths reported to the federal Vaccine Adverse Event Reporting System (VAERS) from 2021 to 2024 were caused by COVID-19 vaccination. He said the coding was conservative. He said the actual number was higher. The memo offered no clinical evidence. It accused the FDA of a years-long failure to acknowledge what new leadership had now uncovered. The underlying analysis has now been revealed. It is a 73-page consensus review conducted by the career scientists in CBER's Office of Biostatistics and Pharmacovigilance (OBPV), the office responsible for post-market vaccine safety surveillance. It is dated December 5, 2025. It was released last week, attached as an exhibit to a letter Sen Ron Johnson (R-Wisc) sent to Department of Health and Human Services Secretary Robert F. Kennedy Jr. The report does not support what the Prasad memo said. A real risk, honestly characterized Myocarditis after messenger RNA (mRNA) COVID-19 vaccination is a known and labeled risk. It has been on the prescribing information for Comirnaty (the Pfizer-BioNTech vaccine) and Spikevax (Moderna) since 2021. Fatal outcomes have not been described. The OBPV team identified that gap and recommended fixing it. The multicenter MACiV study of 333 young patients with vaccine-associated myocarditis at 38 US hospitals reported zero cardiac deaths and zero heart transplants, though late gadolinium enhancement persisted in 60% of patients who had follow-up cardiac magnetic resonance imaging (MRI). The international evidence points in the same direction. Copland and colleagues linked national data on 5.1 million children in England and found a small excess of myocarditis in adolescents after the

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