Jean Rees: Extraordinary COVID Sleuth Takes on the FDA
The devil is TRULY in the details
Dr. Eric Rubin, NEJM VRBPAC member said: "But we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes."
That quote will go down in history as a black mark against Dr. Rubin and the FDA panel.
The incredibly articulate Jean Rees (@JeanRees10) has a thread today delving into documents and correspondence inside and outside the FDA in regards to vaccines for kids. (Jean, by the way, is a data analyst by trade but she should get an honorary double degree in law and medicine in my opinion!)
She’s allowed me to post reproduce her twitter thread here.
Follow Jean and check the entire thread!
Found another interesting statement from the FDA regarding how they would determine whether to auth a vax for kids -- they speak to the "severity of disease". Interesting, since there were ZERO cases of severe disease in the placebo arm of the 5-11 or 12-15 yo trials.
In tandem with ZERO Severe Cases in the placebo arm. This was stated in the 5-11 yo FDA docs: "duration of protection against COVID-19 is currently unknown" juxtaposed against ~2 page of AEs.
FDA used NT50s to immunobridge to 16-25 yos (not the next closest age cohort of 12-15) even though Pfizer has said it can't establish NT50s as a "correlate of protection" NT50s for 5-11 yo trial were 1,198, one month, post 2nd dose - NT50s for a hosp MIS-C patient are ~1,000
Interpretation: The FDAs= didn’t have enough data to rule on the 5 to 11 crowd so they found a substitute age group to make some determinations.
Rees continues:
Dr. Whelan, Pediatric Rheumatologist at UCLA, has warned of getting these Abs "sky high" as they were not protective in his MIS-C patients. Type 1 Interferons from the innate immune system were.
Side note: The mRNA approach to vaccines is all about boosting up antibodies (Abs) to wait around for the virus and then attack it. Jean is pointing out that antibody protection doesn’t really cut the mustard so to speak. This is why the vaccines offer some protection from severe disease in older demographics but they don’t stop infection. And for the younger cohorts - we have no idea.
source: https://www.bmj.com/content/374/bmj.n2101
Which brings me back to another thread, on the spike protein. The FDA did not find it necessary to look at the never felt necessary to examine the pharmacokinetic profiles of the spike protein. Never examined/tested after the spike had been injected.
Jean goes on and this part I need your comments on! Let me know what you think:
With regard to the 5-11 yos, Pfizer was able to change the formulation. Pfizer trialed PBS as the buffer in the clinical trial, but the one that was sent out to the public, has Tris, the same buffer as Moderna. Moderna that is being halted/cautioned against in
I have only been able to find Tris in two other pediatric vaxxes:
1. Nimenrix (Pfizer) for meningitis -- not licensed in the U.S.
2. Act-Hib a flu vax for 2 months - 5 yrs old. More on Tris here: link
With this many unanswered ?s, & with ZERO cases of severe disease in the placebo arm for the 5-11 yo or 12-15 yo trial -- why did the FDA do what it did? FDA based auth on models. Models that they controlled the inputs. They decided on the weights, they decided on the output.
Dr. Eric Rubin, NEJM VRBPAC member said: "But we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes." Find out about safety in 5-11 yos, in the public, on a new formulation, for a trial that yielded ZERO severe cases?!
Great stuff… some of it above my pay grade but I want to highlight more and more of these excellent thinkers and sleuths.
I have not recovered from the shock I felt after watching that FDA Committee meeting. I had drawn my line in the sand long ago that injecting children with these 'vaccines' was the point where I had lost hope. If we made it to the point that we ignored the safety signals in VAERS, saw the ineffectiveness of the jabs, read the peer reviewed papers on potential harms of the spike protein... and STILL decided to jab children, I knew that greed, corruption, manipulation and mass psychosis had prevailed. Millions of children have been jabbed since this past weekend by cowardly parents who are afraid of their own children possibly giving them the virus that these idiots believe has a 1 in 2 hospitalization rate. We are lost.
Something I've worried about with the vaccine trials is that you could have, say, a 1 in 1,000 possibility of a given adverse event following vaccination, but the trials didn't enlist enough people to identify that problem. Or maybe the trials did identify the problem, but we think it's a 1 in 15,000 risk, when it's actually a 1 in 7,000 risk. Rubin's quote speaks to this uncertainty for the 5 to 11-year-olds.