The smoking syringe: booster dosing as a temporary fix to negative effectiveness of primary series? An open letter to Dr. Grace Lee, Chairperson of ACIP on transparency
Dear ACIP Chairperson Dr. Lee,
Comment Tracking Number
Detailed discussion is given below and attached.
At the end of today’s (Nov 19) ACIP meeting, you stressed how important it is for ACIP proceedings to be transparent and to allow for diverse views to be expressed. There was nothing transparent about these proceedings.
The data disclosed today by Pfizer, consistent with data generated by others intensify serious concerns about the Covid vaccine program. FDA, NIH, and CDC are attempting to boost us out of this mess with ever-more concerning cumulative dosing of products that have been acknowledged (Moderna 2Q 2020 SEC report) to be considered as “gene therapy products” by FDA and which attract far higher safety scrutiny (5-15 years long term follow up) than classical vaccines.
If you truly value diversity of opinion I will gladly take your call to discuss how this can be incorporated into the workings of ACIP.
David Wiseman PhD, MRPharmS
- I am subscribed to receive ACIP email alerts and did not receive any. This was a hastily announced meeting. Can I have your personal assurance that I am not on a blacklist?
- There was no opportunity to submit written comments prior to the meeting as the information page did not provide a docket number.
“Any member of the public can submit a written public comment to ACIP. Written comments must be received by TBA for the November 19, 2021, ACIP Meeting, identified by Docket No. TBA using the Federal eRulemaking Portalexternal icon. Follow the instructions for submitting comments. All submissions received must include the agency name and Docket Number.”
At the time of writing this letter, the page still does not display the docket number.
- The agenda was not provided until approximately the start of the meeting. Similar things have happened before.
- The slide presentations were only provided some time afterwards. The presentation by Dr. Oliver was only provided towards to the end of the meeting. The public had no opportunity to review any data and to make comments thereon.
- The ACIP meeting took place after FDA had given wider authorization to booster dosing ONLY this morning. FDA did this with no VRBPAC meeting. Their lack of transparency reflects on ACIP’s transparency, as normally much of the data discussed at ACIP would have already been discussed a week or two earlier at an equivalent VRBPAC meeting. No transparency there.
- Are ACIP members aware that FDA have authorized a formulation change for the Pfizer adult vaccine based only on “analytical comparability” and without any biological assessment of the impact on safety or efficacy? In other words, all clinical data to date (including in children) for the Pfizer vaccine has been with the old formulation. This will affect all those Americans who will now be receiving the booster doses. As someone with experience in pharmaceutical development it is inconceivable why FDA did not ask for, or why Pfizer did not perform any in vitro transfection, in vivo toxicology, biodistribution or even human safety studies. Your committee has just given the green light for a formulation for which there are NO SAFETY OR EFFICACY DATA.
- Are the members of ACIP aware that improving the stability of the Pfizer formulation could INCREASE either the effective dose, or the number of people receiving an effective dose, thereby reducing safety?
- Are the members of ACIP aware that FDA did not verify Janssen’s 2nd dose efficacy data or Pfizer’s children’s efficacy data? Did FDA verify Pfizer’s booster data for study 031?
- Did ACIP members compare the outcomes for the Pfizer 031 booster study with the original 001 study? In 001 there were 8/18198 and 162/18325 cases in the vaccine and placebo groups respectively compared with 6/4695 and 123/4614 cases in 031. Not accounting for selection and time biases, which could make this even worse, did ACIP members notice that placebo-dosed previous vaccinees fared ~ 3x worse than non-vaccinated in first study, and boosted subjects fared 3.5 times worse than vaccinees after the primary series? This suggests not only waning immunity but some detrimental effect.
- Are ACIP members not concerned that Pfizer or Moderna did not present any animal data regarding the toxicology of a third dose?
- Why have Pfizer STILL not performed (reported?) cancer, mutagenicity or male infertility studies?
- Is ACIP not concerned that CDC continues to recommend vaccination in pregnancy despite the package insert stating: “Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy” and despite the conduct by CDC of studies whose protocol states: “there is an urgent need to monitor the safety of these vaccines [..] during or around the time of pregnancy.” Is ACIP not concerned that the study protocols requested a waiver for the requirement to obtain informed consent or parental permission, and that pregnant women, forced to become vaccinated due to mandates, are effectively the subjects of a covert medical experiment?cdc.gov/vaccinesafety/pdf/COVID19-acute-maternal-outcomes-508.pdf
- Are ACIP members aware of the October 26 VRBPAC meeting exchange between CDC’s Dr Cohn and FDA’s Dr. Yang in which Dr. Yang revealed that because VAERS is under-reported, FDA used a database (Optum), apparently unknown to CDC. youtu.be/laaL0_xKmmA?t=21807
Does it not concern you that unlike CDC, Pfizer DID know about this database, seen here in this slide from the October 26 VRBPAC meeting? fda.gov/media/153513/download
Does it not concern you that this reveals least a 4.8x VAERS underreporting for myocarditis? What does this mean for other AEs? For CDC’s entire assessment of safety?
- If ACIP really cared about transparency it would post meeting, docket and agenda details much sooner along with slide presentations.
- If ACIP cared about diverse opinions it would invite qualified doctors and scientists to make substantive presentations with full committee discussion, rather than subject us to a lottery and the opportunity to speak for a paltry 3 minutes.
- If ACIP REALLY cared about diversity of opinions, it would invite qualified individuals with diverse pinions to be committee members.
- Along with CDC’s admission that it does not collect critical information related to naturally acquired immunity https://aaronsiri.substack.com/p/cdc-admits-crushing-rights-of-naturally\
and FDA’s shocking request to complete release full details of Pfizer’s studies only after 55 years https://aaronsiri.substack.com/p/fda-asks-federal-judge-to-grant-it
the circumstances around today’s ACIP meeting only deepen public mistrust in the ability of FDA and CDC to extricate America from this pandemic.