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"Great expectations and generous reading of guidelines underestimate potential risk in oversight of COVID-19 pro-vaccine quality, safety testing and manufacturing: 248 questions for FDA"
Authors: David Wiseman, PhD, MRPharmS and Maria Gutschi, BScPhm, PharmD
- 248 detailed scientific questions
- Published on ResearchGate
How to Cite
Wiseman, D., & Gutschi, L. M. (2025). Great expectations and generous reading of guidelines underestimate potential risk in oversight of COVID-19 pro-vaccine quality, safety testing and manufacturing: 248 questions for FDA. ResearchGate. DOI: 10.13140/RG.2.2.36082.73929
About This Project
This document presents 248 questions to the FDA regarding COVID-19 mRNA vaccine manufacturing processes, safety testing, and regulatory oversight. The questions arise from analysis of regulatory documents, FOIA disclosures, and peer-reviewed research.
Key Areas of Inquiry
- Manufacturing process changes between clinical trials and commercial production
- Residual DNA contamination and SV40 sequence elements
- Adequacy of genotoxicity and biodistribution studies
- Discovery of frameshift proteins
- Regulatory compliance and disclosure
Purpose
The purpose of this compilation is to:
- Promote transparency in vaccine manufacturing and regulation
- Ensure comprehensive safety testing and quality control
- Address scientific concerns raised by researchers and healthcare professionals
- Support informed decision-making by regulatory authorities
- Contribute to the scientific discourse on vaccine safety and efficacy
Question Categories
The 248 questions are organized into seven main categories:
- Manufacturing Process: Changes between trials and production
- DNA Contamination: Residual DNA levels and contamination
- Safety Studies: Comprehensiveness of safety testing
- Regulatory Compliance: Process compliance with guidelines
- Genotoxicity: Potential genetic toxicity
- Biodistribution: Vaccine distribution in the body
- Frameshift Proteins: Discovery and implications