Tuesday, December 19, 2023

FDA Inspects Moderna Main COVID-19 Vax Manufacturing Facility—Finds Numerous Quality Breaches—Issues 483 Warning Letter, Yet Not Disclosed Publicly

A recent Reuters-sponsored Freedom of Information Act (FOIA) request turned up information about Moderna production problems. Specifically, the Food and Drug Administration (FDA) in an inspection discovered serious quality control lapses at the mRNA biotech company’s main production site, including issues associated with the manufacturing of the COVID-19 vaccine known as mRNA-1273 or Spikevax. Interestingly, the inspection occurred back in September, yet to date, the FDA still has not shared the warning letter publicly. See the database. Could this finding in any way tie into DNA fragments found in samples?

Apparently, the FDA inspection was conducted between Sept. 11-21 at the Norwood, Massachusetts production site, used to manufacture both the Spikevax COVID-19 vaccine plus the investigational mRNA cancer regimen currently under development, part of a partnership with Merck, reports Patrick Wingrove.

But Moderna shared that this particular FDA inspection was routine, ensuring that any observations were not implications for product quality or safety concerns.

They said all products released by the company were tested and met product specifications and international regulatory requirements.

What did the FDA find in the inspection?

According to the Reuters entry, the FDA inspectors cited five distinct observations including the company’s failure to verify cleaning tests concerning production equipment used to make the COVID-19 vaccine.

Additionally, the regulatory agency, according to Reuters found that Moderna lacked the appropriate quality control (policies, procedures, processes and systems) at the Norwood site to offer assurance that expired materials would not be used to make vaccines, nor that airborne contaminants did not make it into any products.

According to the report by Patrick Wingrove, the FDA report found 2,000 expired items in the company’s warehouse, plus cold storage not contained in a separate or defined location from other materials.

Another indicator of slipping quality were materials put to use beyond the appropriate expiration date.

No disclosure as to risk to the public

Not known at this point is whether the batches under scrutiny made their way to the public. The agency declined to comment to Reuters. Why did Reuters have to issue a FOIA? Why hasn’t the FDA shared the 483 letters with the public as typically done?

Moderna in a statement said: "Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators."

No Evidence of Harm, But No Evidence of Not Harm Either
Reuters reported no evidence that the quality lapses leading to the FDA observations (writer up in Form 483 letter) led to any consumer harm associated with the COVID-19 mRNA vaccines. On the other hand, they didn’t provide evidence that they have not caused problems.

Favoring a Moderna interpretation is the fact that at least thus far, there have been no FDA-issued recalls of Moderna vaccines.

Expert Commentary

Wingrove spoke with Steven Lynn, a former head of the FDA's Office of Manufacturing and Product Quality who is now a regulatory compliance consultant. He reported that the use of the drug substance in question represented a serious matter but again, it hasn’t been disclosed by the regulatory if any of the output made its way to the market.

“At face value, it appears multiple controls designed to prevent contamination were deficient,” said Lynn.

Japanese Problems

The Reuters piece reminded the reader of problems with Moderna’s quality in Japan in 2021. In that Asian nation, regulators suspended the use of 1.63 million doses of the mRNA vaccine after contaminates were found in some vials produced by a Spanish contract manufacturer called Rovi.

TrialSite has reported on anomalies with Moderna involving its communications around their key vaccine. See TrialSite’s “Moderna--Questions Regarding the Company’s Next Generation mRNA Vaccine.” This media has also questioned the true value, at least in the short to intermediate run, of the company’s pipeline. Other potential issues may present soon, concerning the dependence on one commercial product (the vaccine). The government primed the pump of demand during the pandemic. But COVID-19 national emergency status is over.

In financial disclosures as recently as 2020, the company acknowledged it had no commercial manufacturing experience, and in many ways, like Pfizer, was building the airplane while flying.

Not surprisingly, Moderna went on the record: the COVID-19 vaccines are safe and effective. Yet given the enormous cash infusion into the company thanks to the COVID-19 mandates and government support why have the quality conditions become lax enough for several observations? This finding and the lack of transparency could be indicative of more challenges ahead.


New Study Confirms CDC and Other ‘Experts’ Hurt Children for Nothing

There have clearly been many, MANY aspects of our COVID response that were and remain inexcusable.

Vaccine passports and mandates, the nonsensical curfews and capacity limits, general mask mandates, and of course, closing beaches, should never been forgotten.

But few, if any of our pointless, ineffective COVID-era restrictions were as indefensible as child masking. And thanks to the awe-inspiring incompetence of the CDC and Dr. Anthony Fauci, the United States was a global outlier; obsessively dedicated to forcing toddlers as young as 2-years-old to wear masks.

Schools, youth programs, camps, on airplanes... anywhere children gathered, they were forcibly masked. Horrifying videos emerged of teachers or flight attendants putting masks on crying children.

Calls to mask children in schools have disturbingly continued into late 2023 in certain parts of the country.

But new research has confirmed what was obvious to anyone who studied the data and evidence over the past few years: it was all for nothing.

Child Masking Is Ineffective, New Study Finds

“Trust the science,” “Follow the data,” “Listen to the experts.”

Starting in 2020, those phrases became a relentless mantra of an oppressive government/pharma/media playbook. Instead of examining the actual evidence, data, and pre-COVID consensus, politicians, administrators, and huge swaths of the public put their faith and trust in a few unreliable, self-interested individuals. And with disastrous results.

Following the actual evidence would, in theory, have meant using evidence-based methods as espoused by experts in that field, such as Carl Heneghan from Oxford University. Primarily, that means using a hierarchy of studies, based on quality, to create systematic reviews of well-conducted research.

Instead, we were fed the CDC’s reporting of non-statistically significant results based on phone surveys, and we watched as those results were included in pro-masking reviews designed to promote an ineffective policy.

But a new systematic review from Tracy Beth Høeg and a number of other researchers has just been released on mask mandates for children. And unlike the pro-mask propaganda, it actually attempts to use high-quality evidence to come to its conclusion.

“Background Mask mandates for children during the Covid-19 pandemic varied in different locations. A risk-benefit analysis of this intervention has not yet been performed. In this study, we performed a systematic review to assess research on the effectiveness of mask wearing in children.”
They even used independent reviewers to ensure that there was no bias involved in the study selection criteria.

“Methods We performed database searches up to February 2023. The studies were screened by title and abstract, and included studies were further screened as full-text references. A risk-of-bias analysis was performed by two independent reviewers and adjudicated by a third reviewer.”

That meant that out of 597 studies screened, just 22 were included after meeting the criteria. And in a sign of how the CDC abdicated their responsibility, none were randomized controlled trials (RCT). Sure enough, when filtering out information at a risk of serious bias or confounding, there was no association between forcing kids to wear masks and infection or transmission.

“Results There were no randomised controlled trials in children assessing the benefits of mask wearing to reduce SARS-CoV-2 infection or transmission. The six observational studies reporting an association between child masking and lower infection rate or antibody seropositivity had critical (n=5) or serious (n=1) risk of bias; all six were potentially confounded by important differences between masked and unmasked groups and two were shown to have non-significant results when reanalysed. Sixteen other observational studies found no association between mask wearing and infection or transmission.”

As every intellectually honest scientist, researcher, or expert would admit, their inescapable conclusion is that the “current body of scientific data does not support masking children for protection against COVID-19.”

“Conclusions Real-world effectiveness of child mask mandates against SARS-CoV-2 transmission or infection has not been demonstrated with high-quality evidence. The current body of scientific data does not support masking children for protection against Covid-19.”

Who would have guessed?

Low-Quality Research Used to Create Low-Efficacy Policy

The details of the studies involved in this systematic review are even more damning.

Of the six observational studies that supposedly showed a benefit to masking kids, all were fatally flawed in important ways. Specifically, there were significant confounding differences between unmasked and masked children that undermine any of the reported results.

Differences included the “number of instructional school days, differences in school size, systematic baseline differences in case rates in all phases of the pandemic, testing policies, contact-tracing policy differences and teacher vaccination rates.” With differences that substantial, it’s impossible to determine whether or not the claimed reduction in infection or transmission is due to masks or one or many of those other factors.

This is why randomized controlled trials are so important. And why the CDC should have conducted them during the pandemic years. Yet at the same time, considering the results of masking RCT’s conducted on adults, it’s pretty obvious why they didn’t. Because they knew it would show that masks didn’t work.

The researchers also touched on the fact that some of the studies promoted by the CDC saw their effects vanish upon re-analysis. Specifically, one of the “observational CDC funded study” in the United States claimed to show an association between county-wide mask mandates and pediatric case counts.

Yet when subjected to “expanded reanalysis,” that association disappeared.

That initial result though is how you use low-quality studies to launder low-quality information. The CDC funds a study with what it expects are pre-determined results, the media reports the results of that study—despite being misleading, expert researchers reassess using conventional methods, and the supposed benefit disappears.

But the correction receives none of the attention of the original, because it shows a result the CDC deems unacceptable.

Even observational reporting has shown masks don’t matter at a population level for younger aged individuals. Virginia faced massive criticism for ending school mask mandates early in 2022, only to see cases collapse after a massive surge with mask mandates in place.

Similarly, cases in Philadelphia schools dropped two weeks after the mask mandate was lifted in 2022, and rose substantially for two weeks after the mask mandate in January 2023 came into effect.

As often discussed, in a sane world, this systematic review would permanently shut the door on further discussions of forced child masking. Higher quality research has confirmed that there is no evidence masks are effective and eliminating bias and confounders unsurprisingly shows the same result with children.

But sanity is dead. Therefore the current CDC director defiantly refuses to admit that masking toddlers was a mistake.

She doesn’t have to. Høeg and the other researchers who conducted this review said it for her.


Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs


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