David Wiseman, Ph.D. ACIP Meeting November 2, 2021
Thank you, Chairwoman Lee.
Former FDA medical officer Dr. David Gortler just wrote that FDA Failed In Its Duty To Ensure Vaccine Safety For Children.
After criticizing the UK for rushing to approve Pfizer’s vaccine, Dr. Fauci called FDA “the gold standard of regulation.”
With extensive medical industry experience, I say this is the gold standard of regulatory dereliction
FDA touted its children’s vaccine review as thorough and transparent. Far from it.
For safety 1500 patients followed less than 3 months and another 1500 only 2.4 weeks?
Only a small immunobridging study against the Wuhan strain, still with no immune correlation of protection?
A similar study against delta was marked, “Assay not yet validated; Analyses not verified by FDA” — where is FDA?
The efficacy study yielded only 16 placebo and 3 vaccine cases. With a large imbalance of mysteriously excluded vaccinated subjects, bias in this observer-blinded, but not double blinded, study could drop the 90% efficacy to zero.
See today’s BMJ for allegations of trial unblinding. Where is FDA?
Why was the efficacy analysis not verified by FDA – where was FDA?
Where is Pfizer’s study on troponin levels and subclinical myocarditis? Where is FDA?
FDA’s risk benefit analysis failed to consider:
42% seroprevalence (% kids already immune back in June)
Non-myocarditis serious AE reports are as many as for myocarditis?
Improperly modeled pandemic waves and waning efficacy omitted from the model?
When properly accounted for, we find risks outweigh benefits by nearly 2 to 1 before underreporting
The one thing FDA got right was revealing an almost fivefold VAERS underreporting factor – which is at least fivefold,
and claiming a database more reliable than VAERS that CDC doesn’t know about?
Pfiizer has changed its vaccine formulation, now using a tris buffer that could change particle charge
But no assessment of particle distribution in animals. No safety nor efficacy study. Where was FDA?
With no cancer or mutagenicity studies, especially in young animals, FDA has not assuaged the concern for radiation-like toxicity of this gene therapy product.
With CDC’s study on all-cause mortality and vaccination, we find positive correlations between vaccine coverage and mortality.
Adults receive benefit from the shots from 4 to 26 weeks post immunization, while before or after this time period there are detriments.
In non-vaccinated children all cause deaths correlate with adult vaccine coverage.
Vaccination already appears to harm non-vaccinated children.
Will ACIP request our analysis?
No emergency. Unblinding. Unverified efficacy data, missing and limited safety data, faulty risk-benefit analysis.
You (ACIP members) have nothing to work with and FDA shunted the work of defining risk groups onto you…
While VRBPAC member Eric Rubin, NEJM editor-in-chief, callously remarked, “We’re never gonna learn about how safe the vaccine is until we start giving it.”
FDA has abandoned its responsibility to our children. Will you?