When it comes to mRNA injections for Covid, Americans are 100% dependent on the FDA and vaccine manufacturers to assess and confirm purity and consistency. That might be okay if the testing methodologies that manufacturers and the FDA were still fully transparent, but they’re not anymore.
Not only are the test results confidential, even the methodology used hasn’t been made public. The world just has to take manufacturers’ word that there’s no contamination or variability with the mRNA sequence or its lipid nanoparticle components – even though published epidemiology data indicate otherwise.
Secrecy abounds despite the vaccine manufacturers receiving billions of U.S. taxpayer dollars to conduct their R&D efforts. Transparency should be nonpartisan, especially when it comes to the quality of America’s pharmaceuticals.
On top of that, both the Trump and Biden administrations have proposed lifting Covid mRNA intellectual property rights for mRNA injections. Yet both the FDA and manufacturers are tightly protecting the ingredient information as proprietary or a trade secret. But is it really appropriate to label it “proprietary/trade secret” if the research, development and product were funded with hundreds of millions of taxpayer dollars?
A transparent, publicly accountable FDA should be eager to prospectively test most or all of its regulated products for qualitative and quantitative consistency – and make those findings publicly available.
A transparent FDA would also share its testing methodology for mRNA Covid products for scientists who wish to confirm. But anyone trying to access this information will find it embargoed via an FDA report rendered useless by ludicrous redactions of not just the methodology, but the FDA’s critique of the methodology.
Without a list of ingredients or testing methodology, it is impossible for anyone else outside the FDA or manufacturers to know precisely how to check for product consistency. It is especially troublesome since new, preliminary data using independent methodology have produced troubling evidence of contamination in mRNA Covid product.
Also troubling is the fact that in 2021, the FDA opted to start monitoring America’s pharmaceutical quality via a remote collection of ‘mailed-in’ drug samples – a far less reliable process than testing samples directly collected at manufacturing plants or distribution points by FDA officials.
This ‘mail-in’ sampling methodology is absurd. It would be akin to a state health department monitoring restaurants by requesting them to periodically mail in various items from their menu to be tested for potential food-born contamination or asking restaurants to promise to test the items themselves.
Lack of Specific Dosing Transparency Has No Precedence
Unlike every other FDA-approved pharmaceutical, including a previously approved RNA-based products including patisiran (Onpattro®), none of the Covid injections provide the sequence, molecular weight and milligram strength on their official FDA package label. Normally, official FDA package labelling provides specifics of the actual ingredients in that volume, including the structure, sequence and specific concentration. That is not the case for Covid mRNA labels.
Look up whatever pharmaceuticals you can think of in the Drugs.com database, and you’ll see how all labels provide structure and molecular weight in their official package labelling. Covid mRNA shots are a conspicuous exception to the historical FDA approval practice and ‘truthful label’ rule.
The study raises a number of critically important questions, which can’t begin to be answered without the consistency being verified beforehand – and ‘mail-in’ sampling is not the way to do it.
Providing ingredient transparency and assuring quality via an appropriate sampling methodology is a core mission of the FDA. In fact, it was the primary reason for establishing the agency back in 1906. Americans today deserve complete transparency and improved quality control oversight when it comes to our pharmaceuticals. Our health may depend on it.
Dr. David Gortler is a pharmacologist, pharmacist, research scientist and a former member of the FDA Senior Executive Leadership Team who served as senior advisor to the FDA Commissioner on matters of FDA regulatory affairs, drug safety and FDA science policy. He is a former Yale University and Georgetown University Didactic Professor of Pharmacology and Biotechnology. This article was previously published by the Brownstone Institute.
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I wonder if David McGrogan will read this?
Obviously as a conspiracy realist my only conclusion is that the FDA and CDC clearly have something to hide.
I wonder what that might be?
Well, on speculation, there was clearly something amiss with the methodology used by Pfizer trials in particular, that caused half the trial participants to quit before finishing! Around 50% of the participants did not complete the trials. Why might this have been? If it was illness, then can it be dismissed as coincidence that as much as half of them were too ill to continue after receiving the jab? These volunteers were surely being paid to put their health at risk for an unknown drug, so they would have been financially incentivized to continue!
Furthermore, the placebo group ended up being given the mRNA shot anyway. Is it any wonder they’re compelled to withhold such ridiculous methodologies and details?
For one, 14 y/o Maddie de Garay’s life was destroyed by that trial. They said it was all in her head and refused to pay for her treatment, despite promises made on the consent form.
Her parents should be prosecuted for child abuse. What kind of parent – who doesn’t have a serious ill or dying child who just might benefit from an experimental product – would volunteer their child to be experimented on?
“Bad Pfizer Vaccine Batches Account for 4.2% of doses but 71% of Serious Adverse Events
Explains Why Some Have Severe Side Effects and Others Do Not.”
https://petermcculloughmd.substack.com/p/bad-pfizer-vaccine-batches-account
“In conclusion, the results suggest the existence of a batch-dependent safety signal for the BNT162b2 vaccine, and more studies are warranted to explore this preliminary observation and its consequences.”
https://onlinelibrary.wiley.com/doi/10.1111/eci.13998
“The FDA and Vaccine Manufacturers Still Refuse to Show Us Their Work”
Come on lads! What could they possibly have to hide?
Nothing at all….It will all be clear and transparent in 75 years time!
The mantra of bigpharme as regards ALL new drugsand genetic therapies ie the modified (not messenger RNA – that would not work as it would be destroyed by the immune system) MRNA jabs, they need to know the 3 D’s –
Dosage.
Distribution (as in where, how and why throughout the body).
Duration.
All were and still are, unknown.
I’ll add a 4th to the list of D’s-
Deadliness.
By God we badly need a whistleblower genetic engineer from high up the bigpharma food chain.
Why has this not happened yet, -fear of retribution, threats, being paid for omerta. or maybe they’re quite happy with their work…
Sock Puppet Sunak assures us the jabs are safe.
There’s no need for transparency; assured quality or any information about structure and molecular weight.
The entirely trustworthy midget WEF puppet and PM-with-no-mandate (no medical qualifications whatsoever, but his Mum was a Pharmacist don’cha know) has declared they’re OK.
What more reassurance could anyone want.
FDA not fit for purpose, and covering their arses and those of Big Pharma