Recall of Moderna C19 Injections?

Are Moderna’s C19 injections about to be recalled?

If the injections were baby powder or a jet liner or a car with a defect they would be!

From here:

FDA unearths a minefield of quality issues at the contractor manufacturing Moderna's jabs (substack.com)

https://hedleyrees.substack.com/p/fda-unearths-a-minefield-of-qualitys://hedleyrees.substack.com/p/fda-unearths-a-minefield-of-quality

The SubStack post from Hedley Rees is dated 25 September 2022.

There are a number of flags raised about the manufacturing quality at a Moderna plant. This comes as no surprise to any observer of operations management and logistics in all sectors over the decades. Stuff happens when start-up companies begin to operate at scale – they run into quality problems - quality problems of conformance, compliance and consistency. Even established manufacturing plants require constant quality control monitoring as plants run at high volume for months on end.

Around 235 million Moderna doses had been administered in the US to 5 October 2022 plus around 370 million Pfizer doses. Around 244 million doses from those two suppliers are in fridges approaching their use-by dates. These unused injections are obsolete, as indeed even the efficacy of all injections administered more than six months ago as first, second or booster shots is ineffective. No-one has been vaccinated who received an injection six months ago. In fact, the newly minted concoction targeted to 50% of the original WuFlu viral strain and 50% targeted at the dominant Omicron viral strain is half relevant, at best, in todays BA1, BA4, BA5 and BA2 plus sub-lineages Omicron variant world.

To provide some balance for this Moderna focussed piece, here is a link to the Pfizer advert with claims for its safety protocols:

Manufacturing and Distributing the COVID-19 Vaccine | Pfizer

https://www.pfizer.com/science/coronavirus/vaccine/manufacturing-and-distribution

One might ask whether Pfizer/BioNTech plants, plus all their sub-contractors for quality, transportation and safety processes in German, Belgian, Irish or Croatian law are policed at the same, higher or lower level than those stipulated in US law, but let’s leave that aside.

Here are links to doses administered in the US by volume and manufacturer over the last 20 months, plus the number left on the shelves of fridges.

COVID-19 vaccine doses administered by manufacturer, United States (ourworldindata.org)

CDC COVID Data Tracker: Vaccinations in the US

Now to the Moderna quality breaches. Here is a link to the FDA Form 483 report resulting from an onsite inspection conducted during August 2022

download (fda.gov)  https://www.fda.gov/media/161643/download

Mr Hedley does a great job critiquing the implications of the reports findings. Here are Observations 1, 3 and 4 from the twelve raised in the FDA Form 483.

OBSERVATION 1

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

OBSERVATION 3

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in characteristics of the in-process material and the drug product.

OBSERVATION 4

Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to ensure that batches of the drug product meet appropriate statistical quality control criteria as a condition for their approval and release.

Suffice to say, it begs the question:

“Why are there product recalls with the potential for harm in the baby formula, auto and aviation industries, whereas there is no recall for C19 injections causing actual harms to millions of Americans which contain toxic substances at unknown levels and instructions for the body to create unknown numbers of toxins?”

In the US, this quality control is captured by laws like those cited below – breaches of these are violations of Federal Law – where is the FBI?:

21 U.S. Code § 351 - Adulterated drugs and devices | U.S. Code | US Law | LII / Legal Information Institute (cornell.edu)

https://www.law.cornell.edu/uscode/text/21/351

21 U.S. Code § 360d - Performance standards | U.S. Code | US Law | LII / Legal Information Institute (cornell.edu)

Definition: device from 21 USC § 321(h)(1) | LII / Legal Information Institute (cornell.edu)

Here are the section headings from Code 351:

“A drug or device shall be deemed to be adulterated—

(a)Poisonous, insanitary, etc., ingredients; adequate controls in manufacture

(b)Strength, quality, or purity differing from official compendium

(c)Misrepresentation of strength, etc., where drug is unrecognized in compendium

(d)Mixture with or substitution of another substance

(e)Devices not in conformity with performance standards

(f)Certain class III devices

(g)Banned devices

(h)Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions

(i)Failure to comply with requirements under which device was exempted for investigational use

(j)Delayed, denied, or limited inspection; refusal to permit entry or inspection

There is much more detail describing each of these section headers - quality must be monitored by the regulator. Evidence of such monitoring and quality assurance? Well, the www.howbadismybatch.com provides a wealth of evidence that this is not the case.

An extract from the “States” tab of How Bad is my Batch ?:

“Some states, in particular Kentucky, Montana, Alaska, Tennessee, North Dakota and South Dakota are experiencing 4 x, 5 x, 6 x or even 11 x the number of deaths per 100,000 vaccinated compared to other states. Such a situation should be raising a safety signal, and requires investigation. The higher death rate in these states following vaccination suggests that they may be receiving more toxic batches, or being administered to more vulnerable people.”

Here is a reminder of another article from July 2022.

FDA Colluded With Moderna to Bypass COVID Vaccine Safety Standards, Documents Reveal • Children's Health Defense (childrenshealthdefense.org)

https://childrenshealthdefense.org/defender/fda-moderna-bypass-covid-vaccine-safety-standards-documents/