Saturday, December 23, 2023

Another Friday hiatus

Health problems

Thursday, December 21, 2023

Is this the smoking gun for the Covid lab leak? Blueprint for creating a 'SARS-CoV' virus with an altered spike protein in Wuhan was published in 2018, bombshell new records show

A newly-uncovered trove of documents detailing plans to create a Covid-like virus in China months before the pandemic make the 'lab leak almost certain', experts say.

The records - obtained now by FOIA requests - lay out a plan to 'engineer spike proteins' to infect human cells that would then be 'inserted into SARS-Covid backbones' at the infamous Wuhan virology lab from December 2018.

Just a year later, in late 2019, the Covid-19 virus emerged with a uniquely adept ability to infect humans, going on to cause a global pandemic.

The proposal was made by the now-notorious EcoHealth Alliance, a New York nonprofit that channels US government grants abroad to fund these types of experiments.

Ultimately, the application was denied by the US Department of Defense, but critics say the plans laid out in the proposal serve as a 'blueprint' for how to create Covid, and inadvertently start a pandemic.

The documents also show how EcoHealth deliberately tried to mislead the Pentagon on how risky the experiments were to secure funding.

Sen Rand Paul - who has been a vocal supporter of the lab leak theory - added the documents further support of the 'deception' used by players tied to the Wuhan lab.

Matt Ridley, a biologist and science writer who has written extensively about the potential lab leak in the past, said: 'This latest [document] leak makes the case for a lab leak almost certain.

'A reckless experiment, known at the time to be reckless, probably caused the death of millions of people. 'Scientists and the media conspired to conceal the evidence. Let that sink in.'

The documents were obtained by nonprofit public health research group US Right to Know, which has previously been accused of fueling anti-vaccine sentiments.

The grant proposal was entitled Project DEFUSE: Defusing the Threat of Bat-borne Coronaviruses.

It proposed engineering high-risk coronaviruses of the same species as the original SARS to preempt a human spillover and develop vaccine technology and strategies.

The team sought to synthesize spike proteins with furin cleavage sites that had been designed to bind to human receptors more easily.

The furin has been one of the focal points of debate about Covid-19's origin, with some experts claiming it could only have been acquired through lab experiments.

The grant then proposed attaching the furin to coronavirus strains and infecting mice to see how ill it would make them.

The plan was then to use drugs and vaccines to treat the disease.

Dr Richard Ebright, a chemical biologist at Rutgers University in New Jersey, told 'These revelations are important because the experiments in the grant proposal likely - indeed highly likely - led to the creation and release of SARS-CoV-2.'

The grant proposal has raised concerns and some say it serves as further support of the Covid lab leak theory - that the virus was borne out of gain-of-function research bankrolled by the US taxpayer through Dr Anthony Fauci's former department, a theory the FBI and other government agencies now subscribe to.

The principal investigator on the project is listed as Peter Daszak, president of EcoHealth, a now-notorious health agency that uses US government money to sponsor there's types of experiments abroad.

Other team members listed on the proposal include researchers from Duke-NUS Medical School, University of North Carolina, the USGS National Wildlife Health Center, Palo Alto Research Center and the Wuhan Institute of Virology, the lab where Covid is believed to have originated from.

The proposal listed Professor Shi Zhengli - been dubbed the 'bat lady' for her extensive work on bat coronaviruses at the WIV - as the lead on the project in Wuhan.

Additionally, Dr Ralph Baric was listed as a subcontractor on the project. Dr Baric is a known expert in making recombinant coronaviruses.

The documents show the experiments were proposed to take place at the WIV, which has fewer safety precautions for working with pandemic-potential specimens than the US, which was advertised to the DoD as cost-saving.

The American scientists concealed the lack of safety precautions from DARP in order to avoid national security concerns about conducting high-level biosafety research in China.

In initial proposals for DEFUSE, the lab work was to be done in a biosafety-level 2 lab, which researchers said would appeal to DARPA grant-makers as 'highly cost effective' despite the fewer safety precautions taken in lower-level labs

Dr Baric acknowledged in an edited version of the proposal US researchers would 'freak out' if they knew novel coronavirus engineering and testing was being done in a BSL-2 lab.

Similar experiments in the US are conducted in BSL-3 labs.

A later version of the proposal changed BSL-2 to BSL-3.

Biosafety levels range from one to four, with four being the strictest and experimenting on the most dangerous pathogens.

Dr Baric wrote: 'In the US, these recombinant SARS-CoV are studied under BSL3, not BSL2, especially important for those that are able to bind and replicate in primary human cells.'

BSL-2 labs feature ventilated safety cabinets and researchers must wear surgical masks and lab coats. Experts say pathogen with the possibility of being transmitted through the air should be, at a minimum, performed in a BSL-3 lab, which has researchers in more protective respirators.

Dr Ebright told 'The new documents reveal that EcoHealth Alliance planned to use US Department of Defense funds to perform high-risk virus experiments at WIV at a biosafety level that was inadequate for research with a potential pandemic pathogen.'

He added: 'The new documents also reveal that EcoHealth Alliance deliberately concealed these plans - both the plan to perform high-risk experiments at WIV and the plan to perform them using inadequate biosafety protections - from the US Department of Defense in order to improve the chances of receiving funding.'

Dr Ebright tweeted: 'At this point, there is sufficient evidence to conclude, beyond reasonable doubt, that SARS-CoV-2 entered humans through a lab accident.'

While people who believed and promoted the lab-leak origin were initially accused of being xenophobic and pushing a conspiracy theory, the FBI and several other governmental agencies ascribe to this theory.

The formal DEFUSE grant proposal states the engineering of the coronavirus spike protein would be carried out by Dr Baric in North Carolina.

However, in an earlier comment on the proposal, Daszak said WIV will actually be doing most of the work but this fact was left out of the proposal to make DARPA more 'comfortable' with the details.

Dazsak said in an email: 'If we win this contract, I do not propose that all of this work will necessarily be conducted by Ralph, but I do want to stress the US side of this proposal so that DARPA are comfortable with our team.

'Once we get the funds, we can then allocate who does what exact work, and I believe that a lot of these assays can be done in Wuhan as well.'

In another comment, however, Daszak reiterates his desire to stress the US-focus of the project.

He wrote: 'I am planning to use my resume and Ralph's [Baric]. Linfa/Zhengli, I realize your resumes are also very impressive, but I’m trying to downplay the non-US focus of this proposal so that DARPA doesn’t see this as a negative.'

In a statement Tuesday, EHA called the documents ' incomplete' and said the 'allegations are false based on misunderstanding of edits and comments on the document, and based on misleading out-of-context quotations and a lack of understanding the process by which federal grants are awarded.'

Justin Goodman, president of The White Coat Waste Project, a watchdog group fighting to stop sending American tax dollars overseas to fund dangerous virus research, told the documents prove US tax dollars have 'footed the bill for the shady EcoHealth Alliance and their comrades at the reckless Wuhan lab to supercharge coronaviruses in dangerous gain-of-function experiments.'


High Incidence of Long COVID in Africa, but NOT Among Black Ethnic Groups

Although the continent of Africa was spared much of the fatality rates experienced by other continents, a recent comprehensive review of previous studies and analysis tracking a total of 29,213 people, about 50% of the COVID-19 cases in Africa involves residual long COVID cases. A substantially higher number than in America, for example, which is about 10%, but some studies show higher. With improved ability to track long COVID, this review of the evidence suggests long COVID represents a far bigger problem than previously understood.

Does long COVID emerge as a far bigger problem in the African continent than elsewhere? While estimates of long COVID varied from 2% in Ghana to 86% in Egypt, the most recent study Prevalence and risk factors for long COVID and post-COVID-19 condition in Africa: a systematic review - The Lancet Global Health published in The Lancet Global Health reports the incidence of COVID-19 is in fact, underestimated. With 12 million documented cases and likely, many more un-documented cases, the German and Africa-based study team looks into the evidence on prevalence, associated risk factors for long COVID, and systemic or sociocultural determinants of reporting long COVID.

The Study

Conducting a systematic review incorporating data from PubMed, the Living Overview of Evidence platform, and grey literature sources for publications from Dec 1, 2019, to Nov 23, 2022, the authors included articles published in English, French, Spanish, or Portuguese that reported on any study type in Africa with participants of any age who had symptoms for 4 weeks or more after an acute SARS-CoV-2 infection.

The authors excluded secondary research, comments, and correspondence. The study protocol called for two reviewers to both screen and extract data. Extracting summary estimates, such as sociodemographic factors, medical history, prevalence of persistent symptoms, and symptoms and associated factors, the authors performed a descriptive analysis registering the whole investigation on the results which were analyzed descriptively. The study was registered on the Open Science Framework platform.


Out of 294 articles, (including 24 peer-reviewed manuscripts) the fully vetted patient count equaled 9712 patients from eight African countries.

Out of the entire set of studies, one investigation focused exclusively on children, and one other study included children as part of their study population.

The authors report a low risk of bias associated with the selected studies. The findings suggest an extremely low prevalence of long COVID in the West African nation of Ghana (2%) to extremely high incidence in the northern African nation of Egypt (86%).

What are some indicators of a higher frequency of Long COVID?

Female sex
Non-Black ethnicity
Low level of education
Severity of COVID-19 infection
Underlying Co-morbidity

Interestingly, HIV and tuberculosis were not pegged as factors.

Importantly, other studies have also demonstrated the lack of COVID-19 incidence in sub-Saharan Africa, a fascinating ongoing observation further validated in this study. No one can be certain why, but explanations range from the younger average age in sub-Saharan Africa to different microbiome dynamics to mass exposure to ivermectin at least in some countries (part of anti-parasitic regimen program).

To broaden African observations in this study, the factors influencing reporting included absence of awareness, inadequate clinical data and diagnostics, and little access to health-care service.

Regardless, this study advances the collective knowledge somewhat as to long COVID and the African continent.




Wednesday, December 20, 2023

Uncovering COVID-19 Origins: Why Congress Must Breach Biden’s Stonewall

Next month, the House Select Subcommittee on the Coronavirus Pandemic will interview Dr. Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases. After two days of behind-closed-doors interviews, the subcommittee will schedule a public hearing to take his sworn testimony.

Fauci’s testimony will doubtless cover a wide variety of topics, ranging from masking to vaccine mandates. But rest assured that congressional investigators will zero in on Fauci’s knowledge of, and response to, crucial information concerning the origins of the pandemic in China.

To secure a fully transparent accounting, House and Senate investigators are also pressing the administration to release key details about what Fauci and his colleagues knew about the origin of the pandemic, and when they knew it. But Biden administration officials continue to stall the release of relevant information, offering transparently lame excuses, to block congressional access and public disclosure of unredacted documents.

Team Biden’s persistent lack of transparency on COVID-19 has been nothing short of scandalous. Here is the latest proof:

Exhibit A: Blocking Document Disclosure. In October 2017, well before the outbreak of the COVID-19 pandemic, Dr. Ping Chen, an NIAID official, visited the Wuhan Institute of Virology and prepared a trip report for top NIAID officials.

Sens. Rand Paul, R-Ky., and Ron Johnson, R-Wis., learned of the trip four years later and, in August 2021, wrote Health and Human Services Secretary Xavier Becerra and acting National Institutes of Health Director Lawrence Tabak asking them to release unredacted records of Chen’s visit to Wuhan. In response, the Department of Health and Human Services instead provided a heavily redacted copy of Chen’s report, plus redacted emails.

In a subsequent briefing for Senate staff, Dr. Melanie Egorin, HHS assistant secretary for legislation, said the redactions were for “security” reasons. But that excuse was clearly incorrect because, as the senators noted, HHS had already conceded that national security was not at issue and the documents themselves were unclassified.

As Johnson remarked, “Given HHS’s extensive redactions of unclassified documents, I can only assume that the true nature of HHS’s ‘security’ interest is to protect itself from additional embarrassment over its handling of the COVID-19 pandemic.”

Johnson has since renewed his request to interview Chen and asked for a complete and unredacted copy of her report and related documents. Thus far, no response.

Exhibit B: Flaunting Federal Records Rules. On June 11, 2021, Johnson, Paul, and three other Senate colleagues sent Becerra a letter requesting documents relating to NIH officials’ response to the pandemic’s origins.

The senators had learned that Dr. David Morens, senior scientific adviser to Fauci, had emailed Dr. Peter Daszak, president of EcoHealth Alliance, on Jan. 9, 2020, asking Daszak for any “inside info” on the novel coronavirus. Daszak replied that NIAID had been funding coronavirus research for “the past five years” and taxpayer monies had been funneled to the Wuhan Institute of Virology.

For several years, Daszak’s controversial firm had indeed gotten substantial NIAID funding; and the Wuhan Institute of Virology, which had been a center of China’s coronavirus research, had been a subcontractor of the EcoHealth Alliance.

According to Johnson’s account, upon receipt of the June 2021 letter, Morens told Daszak and a small group of his colleagues that he had retained “very few” documents on these “matters.” Morens cautioned the group to correspond with him outside of official channels at his Gmail address, adding, “I have tried to make sure I have retained no documents that might lead other members of ASTMH to be approached for similar document production.” (ASTMH stands for the “American Society of Tropical Medicine and Hygiene,” Morens’ little group).

Among those receiving this Gmail warning were three prominent virologists, Dr. Kristian Andersen, Dr. Robert Garry and Dr. Edward Holmes, who had published a prominent 2020 article in Nature Medicine arguing that a COVID-19 lab origin was “improbable.” That article was a sharp and rapid reversal of their original assessment of an “unnatural” origin of the coronavirus.

When Johnson learned in August 2023 that Morens was apparently using his personal Gmail in communications concerning COVID-19 origins, he wrote Christi Grimm, HHS inspector general, asking her to investigate the apparent attempt to use to evade requests for public information under the Freedom of Information Act.

Johnson also told Grimm that an unnamed whistleblower claimed that NIH officials may have destroyed sensitive federal records related to the Wuhan Institute of Virology, a serious criminal offense with severe penalties.

For their part, NIH officials claimed they conducted an internal investigation of that allegation, and determined to their own satisfaction that the charge was without merit. Satisfied that there was nothing more to it, the National Archives and Records Administration, the agency charged with the preservation of official records, also dropped its inquiry into the matter.

Remarkably, Grimm rejected Johnson’s request for a Senate staff briefing on the controversy, claiming that it is standard practice to “neither confirm nor deny” the existence of ongoing investigations.

Johnson nonetheless renewed his request that Grimm investigate Morens’ use of Gmail to conduct agency business, the alleged NIH destruction of official agency records, and any effort by Morens or and others to evade the Freedom of Information Act. But she denied the request once again.

In a Nov. 15, 2023, letter to Becerra, recounting the foregoing facts, Johnson tried again:

I request you immediately provide complete responses to my June 2021 and March 2023 letters on the origins of Covid-19—including responsive records contained in Dr. Morens’ Gmail account—produce all text messages or communications contained in Dr. Morens’ HHS-issued cell phones(s) dated from June 1, 2019 – present, and provide a detailed explanation for how HHS will hold Dr. Morens accountable for his apparent mishandling of federal records and potential violations of federal record keeping laws. I also request that HHS make Dr. Morens available for an interview with my Subcommittee staff. Please provide this information and interview by no later than December 6, 2023.

Thus far, no response.

Closing In. Johnson and his colleagues do not have subpoena power. As he told this writer, “I am attempting to convince Chairman Blumenthal to issue subpoenas to the non-responsive agencies. If that proves unsuccessful, you can rest assured that, if I become Chairman of the Permanent Subcommittee on Investigations, subpoenas will be issued and enforced.”

House Republicans do, however, have subpoena power. When Fauci testifies early next year before the House Select Subcommittee on the Coronavirus Pandemic, congressional investigators should probe his recollections concerning Chen’s report and Morens’ intriguing communications.

During his November 2022 deposition in the federal case of Missouri vs Biden, Fauci said he could not recall 174 times in response to questions related to the COVID-19 pandemic. House investigators will thus have an excellent opportunity to refresh his memory on what he learned about the origins of the deadly disease, when he learned it, and how he responded.


The Omicron Family Gets Bigger: Characteristics of New Dominant Subvariant HV.1

According to the Centers for Disease Control and Prevention (CDC), the second half of the November 2023 data demonstrates that the HV.1 subvariant of the SARS-CoV-2 virus comprises 31.7% of all cases in the U.S. This makes it the new dominant subvariant circulating since mid-August. TrialSite previously discussed characteristics of the Eris (EG.5) subvariant which was dominant during the 2023 summer period. The Omicron family in general is highly transmissible, and HV.1 is no exception which makes it a concern for public health. In this article, we will discuss the characteristics of HV.1.

Since the advent of the COVID-19 pandemic, virologists have been on the lookout for new variants of SARS-CoV-2 that might cause concern because of their transmissibility and severity. In this lookout, Omicron was one of the difficult opponents since it spreads so fast. Luckily, the symptoms of Omicron variants tended to be mild including runny nose, sore throat and other cold-like symptoms.

Omicron emerged in November 2021 and took over the Delta variant which was previously dominant. The initial version of the Omicron variant is called BA.1. This was followed by other subvariants – BQ.1, BQ.1.1 and XBB. All of these mutations make it more difficult for our immune systems to recognize and fight the virus. However, this does not mean that these mutations will always cause a more severe disease.

Characteristics of HV.1

HV.1 is a lineage of the Omicron variant of SARS-CoV-2. It evolved from EG.5 (and previously XBB.1.5) and its characteristics are very similar to other Omicron strains. This means that it spreads fast but does not cause severe illness.

Infectious disease professor at Vanderbilt University Medical Center, William Schaffner, M.D. stated that while HV.1 may be more transmissible, it does not appear to cause more severe disease or hospitalizations. “I don’t think people should be very concerned about this,” he said. On the other hand, Schaffner also warns about the possible increase of cases in winter, as was the case for the past three years.

The symptoms of the HV.1 are not different from classical COVID-19 symptoms, including fever, cough, fatigue and sore throat. No new or alarming symptoms have been observed with the emergence of HV.1. The severity of these symptoms can vary depending on an individual's immunity and vaccination status. Additionally, while these symptoms are mostly mild, they can be dangerous for immunocompromised individuals.

Unlike its family members, HV.1 still does not have a catchy nickname, so all the sources still use the scientific Pango name. Healthcare professionals continue to investigate this new variant, and fortunately, most diagnostic tests currently in use can still reliably diagnose the various strains of the SARS-CoV-2 virus.

Will vaccines work for these new variants?

Mutations that cause HV.1 allow it to infect people with previous immunity to the SARS-CoV-2 virus more easily. Therefore, it is an important concern if the vaccines and other preventive and therapeutic measures can keep up with these new subvariants.

Moderna announced in August 2023 that its updated COVID-19 vaccine will target the expected circulating variants of COVID-19. The president of Moderna, Stephen Hoge, M.D., specifically claimed that the new results from the clinical trial data of the updated COVID-19 vaccine illustrated a robust immune response against the XBB strains including the EG.5 subvariant.

Pfizer also created a version of its shots to target the XBB strain, and Reuters mentioned that it showed effectiveness against EG.5 in a mice study.

Although they did not specifically state HV.1, since it is from the same family as XBB, one can assume that updated vaccines are expected to be effective against this new dominant subvariant.

Matthew J. Binnicker, Ph.D., who studies viral infections and is a Director of Clinical Virology at Mayo Clinic, emphasized that along with the updated vaccines, antiviral treatments such as Paxlovid can still work for the HV.1.

A new omicron sub-variant to look out for JN.1 has some concerning attributes. According to the Centers for Disease Control and Prevention (CDC) this variant is the second most predominant one in the United States.

What to expect from future variants

According to a Euronews Next article, Dr. Maria Van Kerkhove, an infectious disease epidemiologist and COVID-19 Technical Lead at the World Health Organization (WHO), emphasized that people have moved on from COVID-19 but the virus is still circulating. She stated that it continues to cause deaths and we need to keep up with it.

To understand and anticipate the future variants of SARS-CoV-2, researchers used molecular dynamics simulations. Investigating the molecular dynamics of mutations helps scientists understand how the virus creates advantages for itself to evolve.

A Think Global Health article envisioned that it is almost impossible to predict the behavior of a new variant before it comes up. But the worst-case scenario is the possibility of a “deltacron” variant which is a combination of the Delta variant’s severity and the Omicron variant’s transmissibility. This might be the scenario in which a greater death rate occurs but luckily, it seems unlikely to evolve. For now, the dominant variant HV.1 does not seem harmful in terms of creating a deadly disease but is still contagious enough to not be ignored.

TrialSite will continue to investigate newly appeared variants and their characteristics.




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.




Monday, December 18, 2023

Chinese Scientists Make Inhalable Dry Powder COVID-19 Vaccine

Scientists from China have made an aerosol-based inhalable vaccine against COVID-19, which they claim provides “effective protection” against infection based on animal trials.

The study, published in the Nature journal on Dec. 13, involved researchers testing “an inhalable, single-dose, dry powder aerosol SARS-CoV-2 vaccine” that they developed. The vaccine uses nanoparticles and contains SARS-CoV-2 antigens, or substances that trigger the immune system to generate antibodies against it. Researchers designed the vaccine to target multiple COVID-19 lineages. The particles were one to four micrometers in size, optimized to be deposited in the deep lung region.

The vaccine was found to induce “strong production of IgG and IgA,” two types of antibodies. It also triggered a response from local T cells, a type of white blood cell that helps fight germs. Collectively, this conferred “effective protection” against COVID-19 among mice, hamsters, and nonhuman primates.

The study noted that while several intranasal immunization products are developing, many are largely limited to the nasal passage. In contrast, aerosol-inhaled vaccines, like the one developed by the researchers, “can penetrate deeper and wider (to major and small airways).” This can confer the vaccine's benefits even to the lower respiratory tract.

The vaccine also showed promise for “readily responding” to future co-circulation of multiple COVID-19 strains and preventing the transmission of the Omicron variant, the dominant variant under circulation in the United States.

The study noted that the current crop of COVID-19 vaccines was delivered via intramuscular injections to alleviate the infection. However, “vaccines delivered intramuscularly do not provide a first line of protection at the respiratory tract owing to deficiencies of secretory IgA and IgG.”

Several intranasal vaccines are being developed or approved to overcome this. But such vaccines “are in liquid form, necessitating cold chain transportation and storage, and generally require two or three inhaled immunizations or the use of a heterologous booster vaccination.”

These limitations “motivated” the researchers to develop “a dry powder vaccine suitable for single-dose inhalation.”

“The inhalable vaccination addresses a known public health issue, in that there is more enthusiasm for this type of administration than for traditional injection, and a single-dose regimen is favorable for substantially increasing the proportion of total completed vaccination recipients,” the study said.

“Furthermore, the dry powder form of the vaccine can provide savings in storage and transportation costs, potentially supporting increased immunization coverage to remote areas,” it stated.

Moreover, the dry powder vaccine uses a microcapsule that is based on a material already approved by the U.S. Food and Drug Administration (FDA), thus boosting the prospects of the vaccine’s “clinical translation.”

“We envision that our inhaled vaccine could serve as a promising multivalent platform for fighting COVID-19 and other respiratory infectious diseases.”

The study received funding from the National Natural Science Foundation of China, Beijing Natural Science Foundation, the CAS Project for Young Scientists in Basic Research, the National Key Research and Development Program of China, the Strategic Priority Research Program of the Chinese Academy of Sciences, CAMS Innovation Fund for Medical Science, and the Major Science and Technology Special Projects of Yunnan Province.

Some “competing interests” were reported. Authors Hengliang Wang and Li Zhu have patent applications related to cholera toxin B subunit (CTB) nanoparticles submitted by the Beijing Institute of Biotechnology. The dry powder vaccine uses CTB with SARS-CoV-2 antigens.

Author Guanghui Ma is an inventor in a patent application related to porous microcapsules submitted by the Institute of Processing and Engineering.

‘Scandal of Epic Proportions’

A Dec. 13 article in Nature, which commented on the study, calls the dry powder vaccine a “unique approach” to dealing with COVID-19. However, it notes that the vaccine’s “safety and immune potency remain to be tested by clinical trials in humans.”

The researchers “have shown that the dry-powder shot remains stable at room temperature for at least one month, but it will be essential to determine how long this stability lasts at room temperature and above, and how degradation of the vaccine affects immune potency.”

“The question remains whether this 1−4-µm (micrometer) dry powder vaccine will be safe and drive an immune response when inhaled by people,” it said while raising concerns about potential “undesired inflammation.”

Regarding the dry powder vaccine’s effectiveness against emerging COVID-19 variants, the article noted that the study demonstrated the feasibility of including the spike antigens of multiple COVID-19 variant viruses into the vaccine. However, the vaccine’s protective efficacy “was not assessed,” it stated.

In addition, “frequently updating the spike antigen in vaccines might not be a viable solution to the emergence of new strains because SARS-CoV-2 evolves rapidly and thereby evades targeting by antibodies.”

The article has stoked controversy due to a statement that “intramuscularly injected vaccines cannot induce immunity in the mucosal tissues of the airways, which is the site of SARS-CoV-2 entry.”

“There's a scandal of epic proportions brewing here. A new study in Nature now asserts that mRNA ‘vaccines’ were, by their very nature, never able to stop the spread. Impossible in theory and practice. Yet that was the excuse used to force everyone to get injected with this stuff,” legal author Hans Mahncke said in a Dec. 14 X post.

“I reported this years ago. The mechanism by which the spike proteins work does not innoculate the epithelial lining from infection. Thus, it can still be spread by sneezing and coughing. Nature is a little late to the party,” podcast host Kyle Becker said in a Dec. 15 post on X.

“Intramuscular vaccines cannot induce mucosal immunity in airways (the site of SARS2 entry). This is why they did not stop the spread of Covid. Nor do much to prevent Longcovid. So let’s put that fable to rest & focus on blocking infection already,” author Dana Parish said in an X post.


Australian Scholar Picks Apart Study Justifying Risk-Benefit of mRNA COVID Vax--Points to Mistakes & Errors

Recently, a University of Sydney professor issued a refutation to an American Journal of Epidemiology (AJE) article declaring the COVID-19 vaccines being worth the risk in the omicron era. Why is this topic relevant? Because as the science unfolds it becomes clearer that the risks associated with the Omicron version of SARS-CoV-2 become less severe (although still quite transmissible) while more safety information becomes available about the COVID-19 vaccines. Not to mention the significant benefits of preexisting and hybrid immunity against Omicron. Will someone lose their job over this one as the author Down Under implies?

Recently Raphael Lataster, Ph.D. wrote “Revisiting a Risk Benefit Analysis of mRNA COVID-19 Vaccines during the Omicron Era” declaring in his blog as well that “Someone may well lose their job over this one.”

The Challenged Piece

Published by Oxford University Press, the AJE is one of the top epidemiology-focused journals. A Johns Hopkins study (Kitano et al.) pointed out that COVID-19 vaccines are still worth the risk in the Omicron era, across all groups. Source.

Ironically, or perhaps not so, Professor Lataster reports that much of the study’s funding came from industry—grants from Merck and Johnson & Johnson. Of course, this doesn’t mean bias on its face but it most certainly should be noted.

Professor Lataster, a supporter of TrialSite, pointed to our attention that the AJE published a follow-up article by Lataster, who informs the world he has zero funding industry. In his rebuttal the Australian academic points to numerous issues and errors with the study.

What’s wrong with Kitano et al.?

As Lataster delineates in this study and corresponding blog:

The study employs peculiar timeframes, such as “Less than 5 months (days 14–149) after the primary 2 doses versus no doses.” No explanation is given. Recall a recent series of journal articles on counting window issues, likely leading to exaggerated efficacy and safety estimates in clinical trials and observational studies, that I was involved with.

"I note that there can be no valid reason why adverse effects caused by the vaccine, in the several months between the 1st injection and 14 days after the 2nd injection, should be ignored”, pointing to an anaphylaxis death occurring very soon after vaccination.

“The authors themselves made reference in their article to a Japanese study, Suzuki et al., which concerns deaths “within seven days after COVID-19 vaccination”, including myocarditis deaths, and found that several of these deaths did “show a causal relationship to vaccination”. Not only are the authors inexplicably omitting relevant data from their analysis, but they knowingly do also so.”

It’s not just when the counting windows begin that is the problem, but their length as well. “The authors only consider vaccine effectiveness and safety up to around 5 months after the last injection. This is problematic with regards to effectiveness as the vaccine is known to rapidly decline in effectiveness around that time and can even become negatively effective. This is also problematic with regards to safety as the vaccine’s long-term safety profile is still, by definition, unknown. We do know that the vaccines can cause myocarditis, however, a potentially long-term and deadly issue. While the authors effectively assume no myocarditis deaths due to a lack of data, there are recent studies that do provide some data on myocarditis deaths caused by the mRNA vaccines, meriting a reanalysis.”

Even with the data as limited and selected as it is, “the stated net benefits of the vaccines are minute”, as “the smallest gain was found to be 18.7 QALY “per 100,000 vaccinees in the 4–5 months after vaccination” (5–11-year-old males with no comorbidities, third dose vs. no third dose, Pfizer vaccine), or less than 2 hours per person”. “And even these are subject to the uncertainties and estimations admitted to by Kitano et al, to say nothing of the aforementioned criticisms, all of which may well reduce these QALY gains to effectively zero, or even negative figures.” Read that again. By having very limited data, and by being very selective with that data (just ignoring highly relevant data, because why not…), their stated net benefits are almost nothing. The actual net benefit could be zero, or even less than zero. Worth potentially risking your life for?

Lataster comments, “While attempting to argue that COVID-19 vaccination is still worthwhile, the authors inadvertently demonstrate that in the omicron era, COVID-19 is now extremely benign and that the potential benefits to the vaccines are minimal at best, at least in the young and healthy.”

TrialSite emphasizes the importance of critical review of journal material during the COVID-19 period, and frankly all the time. Industry bias, ever so subtle, is real and must be identified, called out, and countered.

While it's up to the reader to determine the merits of (Kitano et al.) and the Lataster refutation, it’s unfortunate that more media channels don’t encourage this kind of unbiased, objective presentation for critical review.




Sunday, December 17, 2023

FDA Fails to Address DNA Adulteration Concerns

The failure of government regulatory authorities to identify and disclose DNA fragment contamination of the Moderna and Pfizer/BioNTech COVID vaccine products prior to independent laboratories disclosing their contamination study findings has raised serious questions about quality control oversight of the manufacturing processes used to produce these products, as well as their overall safety. Rather than rigorously addressing specific safety questions concerning the previously undisclosed contamination or adulteration of both modified-mRNA vaccines, in a written Dec. 14 reply to a prior Dec. 6 inquiry, Dr. Peter Marks of the FDA Center for Biologics Evaluation and Research has resorted to redirecting, gaslighting, and stonewalling the Surgeon General of the State of Florida.

Experts from around the world have raised concerns about the safety implications of DNA fragment contamination in COVID gene therapy-based “vaccine” products. Leading regulatory authorities have conceded that these rushed novel and complex biological products are contaminated, and deliver both synthetic modified messenger ribonucleic acid (mod-mRNA) and a wide variety of uncharacterized shorter DNA fragments into the cells and tissues of those who have accepted these product. The Biden administration has previously mandated and currently markets these products in the United States for Americans of all ages including during pregnancy, fraudulently claiming that they prevent SARS-CoV-2 infection and spread as well as COVID-19 disease and death.

These DNA fragments are left over contaminants from manufacturing the mod-mRNA “payload.” The contamination was first detected and reported by experienced U.S. and Canadian genomic researchers, and their findings have been replicated by many other laboratories.

To manufacture the COVID shots, both the DNA contaminants and the mod-mRNA are assembled into the most highly active lipid nanoparticle genetic delivery system ever developed, and this final drug product has been injected into over a billion human arms. After injection, the material distributes throughout the body and delivers both DNA and mod-mRNA to a wide variety of cells and tissues including ovaries.

Both mRNA and DNA can control a wide variety of cell functions. The mod-mRNA directs cells and tissues of the recipient to produce genetically engineered SARS-CoV-2 spike protein (as well as other uncharacterized “frameshifted” proteins and peptides). The DNA fragments come from the circular bacterial DNA (“plasmids”) used to manufacture the mod-mRNA. These plasmids include DNA sequences which can produce a variety of functions inside both bacterial and human cells; proteins which confer antibiotic resistance, sequences which guide DNA into the nucleus of cells, and highly active genetic switches for turning on adjacent genes in either bacterial or animal cells.

In a Dec. 6 letter from Dr. Joe Ladapo M.D., Ph.D. sent to FDA director Robert Califf, the following questions concerning DNA contamination of these mod-mRNA products were posed:

“1. Have drug manufacturers evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from the mRNA COVID-19 vaccines alongside the additional risk of DNA integration from the lipid nanoparticle delivery system and SV40 promoter/enhancer? Has FDA inquired any information from the drug manufacturers to investigate such risk?

“2. Do current FDA standards for acceptable and safe quantity of residual DNA (present as known contaminants in biological therapies) consider the lipid nanoparticle delivery system for the mRNA COVID-19 vaccines?

“3. Considering the potentially wide biodistribution of mRNA COVID-19 vaccines and DNA contaminants beyond the local injection site, have you evaluated the risk of DNA integration in reproductive cells with respect to the lipid nanoparticle delivery system?”

Earlier today, Dec. 15, the Florida Department of Health publicly posted the FDA response authored by CBER director Dr. Peter Marks to Surgeon General Dr. Ladapo dated Dec. 14, 2023. The response failed to address the questions posed by the Surgeon General, instead offering unsubstantiated platitudes such as “safe and effective” combined with redirection to irrelevant and poorly documented information.

Dr. Peter Marks (a hematologist and oncologist), together with the U.S. Government biowarfare specialist Dr. Robert Kadlec, was responsible for initial creation and regulatory management oversight of Operation Warp Speed, is very invested in the success of this program and has proposed that it be expanded to include cancer treatments. Operation Warp Speed exploited the special U.S. Emergency Use Authorization regulatory pathway to bypass many of the regulatory steps and procedures normally required to insure the safety and effectiveness of vaccine products, which typically require up to a decade of development before widespread deployment.

Worldwide administration of the resulting injectable products has been associated with over seventeen million excess deaths (globally), as well as large numbers of cases of heart damage (myocarditis) with a perverse predilection for young people, contradicting the repeated propaganda statement that these products are safe. U.S. Government officials have colluded in a widespread campaign to cover up data concerning myocarditis side effects. There are over 700 peer reviewed academic publications documenting these and many other types of damages and illnesses caused by these products.

In one of the most intensive global propaganda and marketing campaigns ever deployed, it has been widely asserted that these products will enable herd immunity, will prevent infection, replication, and spread of SARS-CoV-2, and will also prevent COVID-19 disease and death. However, it is now widely recognized that these mod-mRNA provide none of these benefits and are therefore not effective. The messaging used in this propaganda campaign has been supported by over 1,200 peer reviewed academic publications providing propagandists and marketing specialists advice how to overcome “vaccine hesitancy.”

Despite the proven and documented lack of safety and effectiveness, overlapping layers of legal protection (indemnification) prevent both deceived public and damaged individuals from obtaining compensation for this fraud.

In his response to the Surgeon General’s questions, Dr. Marks has provided a series of unsupported or misleading statements, combined with circuitous and not scientifically rigorous responses to the specific questions posed. These responses appear to suggest that the FDA has failed to require DNA integration studies to determine the dose limiting toxicity of bacterial plasmid DNA fragments when delivered into animal models using the specific formulations now injected into over a billion human beings. Dr. Marks failed to cite any studies which specifically address DNA fragment integration risks to those receiving these products, instead referring only to studies which can only detect other types of genotoxicity. DNA fragment integration is one of multiple types of genetic damage which such lipid nanoparticle formulations may cause.

In his response to Dr. Ladapo’s inquiry, Dr. Marks cites an FDA guidance document which addresses general requirements for assessing DNA contamination of vaccines (such as influenza) which are manufactured using cultured cell lines. This type of manufacturing process often yields vaccine material which is contaminated with large fragments of chromosomal DNA from the animal cells used to grow the vaccine. This contamination is substantially different from that involving the mod-mRNA products, in that we now know that those products are contaminated with small DNA fragments which are more likely to cross into the region of cells which contain the genome, and in contrast to traditional vaccines these mod-mRNA products and their DNA contaminants are assembled into highly active lipid nanoparticle delivery formulations, greatly increasing the risk that such DNA will enter both the cells and the part of the cells which house the genome (the nucleus).
Despite the fact that the risks of DNA contamination with traditional cell-based vaccines are much lower than for the novel mod-mRNA lipid nanoparticle-based products, the cited FDA guidance documents include the following specific warnings concerning DNA contamination:

“Residual DNA might be a risk to your final product because of oncogenic and/or infectivity potential. There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.”

In his response to the Surgeon General, Dr. Marks refers to a specific clause in this guidance to support safety of the levels of DNA fragment contamination, which in turn refers back to a WHO document. What he fails to acknowledge is that this guidance refers to DNA contamination in a directly injected (parenteral) vaccine, not one employing the most highly active DNA and RNA lipid nanoparticle delivery system ever devised by man. This oversight either reveals Dr. Marks’ profound ignorance of this significant difference (despite the Surgeon General having pointed this out in his initial letter), or a fraudulent attempt to gaslight and obfuscate the truth of the matter. Either ignorance or intentional cover up, hard to differentiate. Here is the cited clause:

“You should limit residual DNA for continuous non-tumorigenic cells, such as low-passage Vero cells, to less than 10 ng/dose for parenteral inoculation as recommended by WHO (Ref. 31) ...”

Reference 31 refers to a WHO document developed and published in 1998, less than a decade after my initial discoveries relating to large scale mRNA manufacture and delivery and about the same time as Kariko and Weissman’s first report of their work with pseudouridine. This outdated WHO statement predates the development of the current generation of mod-mRNA delivery technology by approximately 20 years, and is completely irrelevant.

In additional efforts to cover up the apparent failure of the FDA to require the specific DNA integration toxicology studies both logically needed to rigorously assess patient risk and required for all previous DNA vaccine products prior to human experimental use, Dr. Marks cites the Summary approval document for the Pfizer/BioNTech mod-mRNA product “COMIRNATY” as well as the Summary approval document for the Moderna “SPIKEVAX” product. Specifically, Dr. Marks makes the following assertion:

“[S]tudies have been conducted in animals using the modified mRNA and lipid nanoparticle together that constitute the vaccine, including the minute quantities of residual DNA fragments left over after DNAse treatment during manufacturing, and demonstrate no evidence for genotoxicity from the vaccine ...”

The very limited studies performed are incapable of detecting DNA fragment integration. Once again, this statement reflects either intentional gaslighting or incompetence. The COMIRNATY document provides no specific references to genotoxicity or integration studies having been performed prior to human authorization. In contrast, the SPIKEVAX document (SPIKEVAX is not the same product as COMIRNATY) lists the following assays performed:

“Other Supportive Toxicology Studies

“The safety of SPIKEVAX is further supported by the aggregate rat repeat-dose toxicity profiles observed in six GLP toxicity studies of five vaccines formulated in SM-102 lipid particles containing mRNAs encoding various viral glycoprotein antigens, demonstrating tolerance of repeat doses of these vaccines without any detrimental effects. Three other toxicology studies were also reviewed in support of safety of SPIKEVAX. A study report from an in vitro rat micronucleus assay evaluating the genotoxic potential of (b) (4) mRNA in SM-102 LNP revealed no genotoxic effects of SM-102 LNP. In addition, study reports from a bacterial reverse mutation test and an in vitro mammalian cell micronucleus test of PEG2000-DMG were also reviewed. No genotoxic effects of PEG2000-DMG were observed in these studies.”

Under the heading “Other Supportive Toxicology Studies,” this regulatory submission demonstrates the gross inadequacy of the testing performed for SPIKEVAX, which despite this inadequacy apparently still exceeds the testing performed for COMIRNATY. The SPIKEVAX documentation refers to an in vitro (ergo in a test tube) rat micronucleus assay of the formulated mRNA. No mention is made of any level of DNA fragment contamination in the tested preparation. The in vitro rat micronucleus assay is a method for rapidly testing the activity of a pharmaceutical or radiologic treatment in grossly disrupting chromosomes. It is completely inappropriate and incapable of detecting insertional mutagenesis. PEG2000-DMG is one of many components of the lipid nanoparticle, and these test results are irrelevant to the questions raised by the Surgeon General, as neither mod-mRNA nor DNA fragments were tested, and once again the tests performed would fail to detect any integration events.

The appropriate testing for DNA fragment integration is covered in the FDA guidance document “Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications,” which Dr. Marks has failed to cite in his response. Dr. Marks’ makes the following assertion in his response to the Surgeon General:

“On first principle, it is quite implausible that the residual small DNA fragments located in the cytosol could find their way into the nucleus through the nuclear membrane present in intact cells and then be incorporated into chromosomal DNA.”

This statement is directly contradicted by the guidance cited above, which states the following:

“Theoretical concerns regarding DNA integration include the risk of tumorigenisis if insertion reduces the activity of a tumor suppressor or increases the activity of an oncogene. In addition, DNA integration may result in chromosomal instability through the induction of chromosomal breaks or rearrangements.”

In direct contradiction to the poorly cited assertion made by Dr. Marks, Moderna acknowledges these risks in its own patent filings. In the issued U.S. Patent #US2019/0240317 A1 (see image above) titled “HPIV3 Vaccines,” Moderna provides the following text:

“[0012] Deoxyribonucleic acid (DNA) vaccination is one technique used to stimulate humoral and cellular immune responses to foreign antigens, such as hMPV antigens and/or PIV antigens and/or RSV antigens. The direct injection of genetically engineered DNA (e.g., naked plasmid DNA) into a living host results in a small number of its cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.”

The FDA’s own “Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications” provides clear guidance concerning how the risks of DNA integration risk should be addressed:

“A typical integration study will assess all tissue(s) containing persisting DNA plasmid. We recommend that at least four independent DNA samples be analyzed. Each sample may include DNA pooled from several different donors. Q-PCR is generally used to detect and quantify the amount of plasmid DNA present in each genomic DNA preparation. Unintegrated plasmid DNA may be separated from high molecular weight genomic DNA by gel purification. Concatamer may be eliminated by restriction endonuclease digestion targeting a rare motif present in the DNA plasmid. Specifically designed PCR primers may be used to confirm integration and identify genomic integration sites.”

Based on these and many other examples of existing FDA guidance and prior regulatory submissions, there are both well-developed protocols and well-established precedent for performing DNA fragment integration studies. The failure of Dr. Marks to correctly cite FDA guidance, past precedent, or reference any relevant studies performed to assess these risks in the context of either the COMIRNATY or SPIKEVAX regulatory dossiers clearly demonstrates a tragic failure of proper regulatory oversight and diligence.

In its response to an appropriate and well-documented inquiry from the Florida Surgeon General, the U.S. FDA has clearly failed to establish that it was aware of the contamination or adulteration of COMIRNATY or SPIKEVAX final drug products with plasmid DNA fragments, and has completely failed to insist on the testing necessary to both establish dose limiting toxicity of DNA fragments when delivered to animals or humans using these highly active lipid nanoparticle formulations. Furthermore, in the written FDA response to the Dec. 6, 2023 inquiry from Dr. Ladapo concerning the risks of this contamination, the FDA has demonstrated a lack of rigor in addressing the questions posed which is combined with a series of statements which can only be interpreted as either ignorant, incompetent, or intentionally misleading.

The Surgeon General and citizens of the State of Florida, the U.S. public, and the citizens of the world deserve better than to be mislead and gaslight about the risks of the widely acknowledged DNA fragment contamination present in virtually all batches and lots of COMIRNATY and SPIKEVAX. Based on FDA’s the abject failure to address these risks in a serious manner, and its willingness to substitute platitudes, half truths, and outright falsehoods for actual data, the FDA, CBER, and Dr. Marks have once again damaged the credibility of the U.S. HHS in the eyes of both the U.S. public and the world. We all deserve better, but in the interim it must be concluded that the risks associated with DNA plasmid fragment adulteration when delivered with the highly active lipid nanoparticle formulations of COMIRNATY and SPIKEVAX are both real and uncharacterized, and consistent with U.S. Federal statute CFR Title 21, CHAPTER 9, SUBCHAPTER V § 351, the products must be withdrawn from the market until the necessary tests have been performed and safety demonstrated.