The following is a more in-depth analysis of the December 16 ACIP meeting to discuss the contraindication for the Janssen vaccine.
Dear ACIP Chairperson Dr. Lee,
We refer to the letter to you from one of us (DW) of November 19, submitted to the docket Regulations.gov (once a number had been assigned) and published as on Trial Site News. An Open Letter to Dr. Grace Lee, CDC ACIP Chairperson on Transparency (trialsitenews.com) DW remains in anticipation of the pleasure of your reply to that, and this letter, as to your proposed actions. We welcome an honest discussion of our analyses. Note this letter has been submitted as an official written comment for the docket CDC-2021-0133.
To enhance transparency and informed consent, we use the term “vaccine” (q-vaccine) to disclose the fact that these drugs meet FDA’s definition of gene therapy products and constitute a novel class distinct from classical vaccines. Key concerns are summarized here under these main headings, with detail below and attached.
- Contraindications warranted for all q-vaccines to include other events (thrombosis, myocarditis, etc.). Focusing on a small subset of events in one q-vaccine is regulatory misdirection.
- Insufficient guidance on coagulopathies for Janssen and other quasi-vaccines
- COVID-19 q-vaccine in children 5-11 years: contraindication and re-evaluation of use warranted
- ACIP should be discussing ever reduced benefit for greater risk: Attempting to boost our way out of new variants is the immunological equivalent of heroin addiction.
- Full review of the existing EUAs and BLA is warranted due to greater prevalence of AEs as well as death far exceeding the TTS rate for Janssen and the death reports for all three Covid-19 quasi-vaccines.
We extend earlier remarks concerning your concluding comments at the Nov 19 meeting stressing the importance of transparency in ACIP proceedings and the expression of diverse views. Given the circumstances of how Dec 16 meeting was announced, concerns about opacity are deepened. As before, the late notice, the late publication of a docket number, the failure of email notifications and late posting of presentation slides, require corrective action. Based on CDC and FDA decisions, millions in America and around the world are subjected to mandates and other harsh measures that could include imprisonment and loss of employment. The opacity displayed by ACIP not only deepens mistrust within the American public but reverberates around the world. You must be cognizant of your responsibility. Transparency Concerns.
In part 2 of the CATalyst series, this in depth video lecture by Dr David Wiseman shares more details about the second ACIP (CDC) letter regarding the data analysis risks of C19 vaccines, the implications of ignoring the data, and urgent recommendations from four scientists. You can read the urgent letter to ACIP dated 16 December, and you can watch the CATalyst video interview with TSN’s Shabnam Palesa Mohamed and Dr David Wiseman. Here is Dr Wiseman’s first open letter to ACIP’s Dr Grace Lee, published on Trialsite News in November last year.