David Wiseman, PhD, is an experimental pathologist with a background in pharmacy, pharmacology and immunology. At Johnson & Johnson, as one of only 66 Research Fellows, he led a research program in the prevention of post-operative adhesions where his duties included pharmacovigilance. He focuses on fibrosis and pain, running his own company providing R&D services for the development of medical products since 1996. He was invited to participate in Senator Johnson’s expert Covid-19 panels in January and December 2022.
Audio of Wiseman's oral remarks: https://player.vimeo.com/video/809903500#t=84m37s
"Capsule
A committee of the National Academies convened on March 30 2023 to 'review relevant literature regarding adverse events associated with [Covid-19] vaccines.' To supplement oral remarks delivered at the meeting and to assist the committee’s deliberations, further detail is provided here along with a summary (with original documents) of our written comments submitted to FDA and CDC advisory committees on Covid-19 Vaccines. These comments contain a number of novel analyses conducted relating to Covid-19 vaccine safety. This document further discusses:
- Hasty vaccine development, undisclosed sequences and kinetics of modRNA and spike protein
- Novel heterotrimers formed after bivalent vaccination
- Gene therapy nature of the Pfizer, Moderna and Janssen Covid-19 vaccines
- VAERS underreporting
- Safety signal analysis
- Masking of safety signals
- Ischemic stroke
- Negative efficacy: an indicator of immune suppression?
- All-cause mortality and vaccination
- Concerning cancer reports
- Transparency, scientific engagement, rebuilding trust in public health
We show here a number of instances of FDA or CDC analyses being unreliable or highly limited...
1. Original oral remarks
'... These expedited and still experimental vaccines are the most complicated medical products ever deployed. Sequences remain undisclosed and questions about the persistence of mRNA and spike have been evaded despite reports that they linger many months. The Moderna, and likely Pfizer bivalents elicit up to four distinct spike proteins, including two novel heterotrimers with likely new toxicology.
Despite meeting FDAs biologic definition of gene therapy products, these vaccines are excluded from the gene therapy guidance, with no public comment from FDAs gene therapy infectious disease vaccine labs. Concerns for autoimmune, neurological, hematological and other diseases must remain on the table. We see cancer signals...
Most concerning are data, including CDCs’, showing negative vaccine efficacy, indicating immune suppression. A Cleveland clinic study recently remarked that theirs was not the only one to find 'a possible association with more prior vaccine doses and higher risk of COVID-19.
We have found from European data, correlations between vaccination coverage and all cause mortality. There is a time dependency critical to understand the effect of these vaccines with mostly periods of detrimental associations, punctuated by briefer periods of benefit...'
2. Introduction
... This document is not all encompassing with many areas requiring further consideration, most notably the effects of Covid-19 on reproductive function."
Preprint article