Pfizer didn't do science; Moderna did science and showed they made kids sick; WARP SPEED to FUTURE FRAMEWORK! Let's change genetic products without further human trials... Because SCIENCE!
Plus: Neither Study included proportional minorities and neither had mention or research on impact to disabled children.
Summary of the last week:
My comments on Moderna are here. I remain concerned that Moderna presented evidence of concerning safety signals in their data package presented to the FDA which included Higher rates of hospitalization in the children that received their products, and much higher rates of Croup, Pneumonia, and RSV in the babies that received their products. The FDA decided that the safety signal wasn’t important because science. No seriously they said it wasn’t important because Moderna said it wasn’t important. Moderna’s vaccine efficacy in these age groups was low against current circulating variants of COVID19.
Remember that post ‘It’s not Fair!’ Where I speculated that the FDA had withheld Pfizer’s Materials until the last minute so that we the public would be denied the opportunity to give timely comment? Others speculated that Pfizer was going to look a lot better than Moderna, and Moderna was just the Scape goat. Turns out I was right. What worse than Moderna doing a study, showing that they hurt kids, then talking around it in order to make a couple million dollars? Pfizer not even doing a controlled study and then reporting it so that they could make a couple hundred million dollars.
The studies are located on the FDA Website here: Pfizer, Moderna
Pfizers study:
It was really difficult to read, and I am trained to read these types of studies. The study design appears to have been corrupted at the initial endpoint when Pfizer realized that their intervention had little to negative effect, at which point they stopped doing what we would normally call a Randomized Controlled Trial.
It appears that Pfizer then unblinded the study participants and vaccinated the control group.
Pfizer also failed to report endpoints on over 2/3 of the study participants and did not explain what happened to those participants.
I leave it to you to speculate about why Pfizer would do that.
That being said, I have been alarmed to have heard on the News reports of ‘80'%’ efficacy of Pfizer Vaccine. That is just misleading. James Rogusky has a substack on the matter where he has developed a flyer putting the information in one place:
If you are a Bad Pharma Company and have products worth billions that are utterly failing in experiments with humans in the real world, you may getting worried because it might get pretty difficult to justify the authorizations and continued use of your products. You might end up embarrassing the Public Health Agencies, Politicians, The Government Regulators, and the all the health care providers that got their information from those Health Agencies and regulators instead of reading the Data and Materials from the research that was done on your products. Your investors might end up loosing their shirts when the world finds out that you had committed fraud.
In the real world, Bad Pharma Companies dont have to worry about that, because the FDA is also working with them.
The FDA is going to help BAD Pharma out here as well:
The Future Framework!
The FDA’s solution to this problem of failures to provide evidence of efficacy appears to be something out of the Goodfellas: ‘Forget about it.’ Let’s eliminate the requirements for actual experimental designs in the real world with real humans for changes in genetic products related to COVID19. In effect, the FDA is set to eliminate real world experimental Randomized Controlled Human Trials from future COVID19 genetic product upgrades. This is their solution to the problem the current genetic products do not work very well and Bad Pharma is having problems using our, (now Bad Pharma’s) BILLIONS of dollars to gather the gold standard Double Blinded Randomized Controlled Trials showing that the genetic products actually continue to work at all without causing harm.
For those of you religious devotee’s to the Narrative, please understand that I am talking in terms of actual scientific data in Large Cohort, Randomized Double Blinded Placebo Controlled Trials providing evidence of efficacy and continued safety in Genetic Products. I am well aware of the religious hyperbolic mantra ‘Its Safe and Effective’ that everybody must chant and believe regardless of the Science if they are going to remain free to speak in a healthcare setting, but I have my own religion. You are welcome to yours. See my post Live not by Lies. And Follow the Science.
If these products really are safe and effective, what the problem with us continuing to see the data showing they work in the real world?
Thanks Capcom! This all sounds like a plot from a Resident Evil video game franchise, complete with the creepy “Future Framework” label. But it is the topic of the next VRBPAC meeting on June 28th.
James has another piece on this and some action items. I like that he points out that there are no materials available for timely and meaningful public comment. As I have stated before in public comment I find the withholding of materials during the comment window negligent at best. Check out his call to action. Here is the link for public comment.
Race and Disability in the Pfizer and Moderna studies on young children:
In clinic I have occasionally been asked about the racial make up of studies by parents that are concerned that research is focused on racially white groups. So I am going to add this here. It may not be important to you, and frankly it didn’t seem important to the FDA either. At least I didn’t notice any comments on it.
Moderna and Pfizer tested their products disproportionately on White Children. The studies did not proportionately reflect the racial diversity of the populations in the USA at the time the studies occurred.
I have also been asked about whether there was any research into impact of these products on children with disabilities. Moderna and Pfizer did no research into and made no mention of the impact of these products to children with disabilities.
I included screen shots that were obtained from the studies located on the FDA Website here: Pfizer, Moderna:
Moderna Study Participants were:
3.1% Black in the 6 -23month group
4.5% Black in the 2- 5 year group
10% Black in the 6 -11 year group
3.4% Black in the 12 - 17 year group
Pfizer Study Participants were:
3.7% Black in the 6-23 month group
4.9% Black in the 2-4 year group
Moderna Tables:
Pfizer data:
6 - 23 month group
2 - 5 year group
-Anthony APRN