FDA Shuts Down Enquiries About DNA Contamination In COVID Vaccines

 by Maryanne Demasi via The Brownstone Institute,

The recent findings of DNA fragments in the Pfizer and Moderna Covid-19 vaccines has led many to question why the FDA, which is responsible for monitoring the quality and safety of the vaccines, has failed to sound the alarm.

For years, the FDA has known about the risk posed by residual DNA in vaccines. Its own guidance to industry states:

“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.”

Put simply, the FDA acknowledges the possibility that fragments of DNA left over by the manufacturing process can be incorporated into a patient’s own DNA, to potentially cause cancer.

FDA and WHO guidelines consider the amount of residual DNA in a single dose of traditional vaccine should not exceed 10 ng (one billionth of a gram).

But this limit – used for traditional vaccines – is unlikely to be relevant to the mRNA vaccines whose lipid nanoparticles can penetrate inside cells to deliver the mRNA efficiently.

A recent preprint paper by Speicher et al analysed batches of the monovalent and bivalent mRNA vaccines in Canada.

The authors found “the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines. Using fluorometry all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose.”

Speicher et al also reported finding fragments of DNA larger than 200 base pairs (a measure of the length of the DNA) which also exceeds FDA guidelines.

Notably, the authors commented that for the Pfizer product, the higher the level of DNA fragments found in the vaccine, the higher the rate of serious adverse events.

Some experts say the risk of genome integration in humans is very low, but a recent publication in Nature found that around 7 percent of cells are integrated when mixed with a transfection solution containing linear pieces of DNA.

Is the FDA Concerned?

The US Food and Drug Administration (FDA) continues to insist that any residual DNA contamination in the Covid vaccines is not a problem and that it “stands behind its findings of quality, safety, and efficacy for the mRNA vaccines.”

“While concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the minute amounts of residual DNA do not cause cancer, or changes to a person’s genetic code,” added the FDA.

The FDA would not provide the “available scientific evidence” to support its claim, but it’s worth noting that the vaccines’ own product labels show that genotoxicity and carcinogenicity tests were not carried out prior to their use.

David Wiseman, a research bioscientist involved in medical product development and co-author on the study by Speicher et al said the FDA’s claim that there is no evidence of a cancer link is becoming “untenable.”

“The CDC’s own analysis on the vaccine’s safety signal in VAERS shows there could be a signal for some cancers,” said Wiseman pointing to a report he co-authored and sent to the National Academies.

In the table (highlighted in yellow), a safety signal is considered to be significant, and worthy of further investigation, if the value in the column marked PRR exceeds 2 and the value in the Chi-Square column exceeds 4.

The FDA would not confirm if it found levels of DNA that exceeded acceptable levels, nor if it was investigating further.

Instead, after months of enquiries, the FDA sent boilerplate responses to me (and other media) saying, “With over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”

In response to a list of questions about its testing and oversight, the FDA said it “does not have any additional information to provide at this time.”

Poor Manufacturing Oversight

We now know that Pfizer’s vaccine used in the clinical trials (PROCESS 1) was manufactured differently to the vaccine that was injected into the wider population (PROCESS 2).

This switch from PROCESS 1 to PROCESS 2 is what introduced the plasmid DNA impurities (see red circles), which could change the safety profile of the vaccine.

I asked the FDA if it had any human data on the comparison of the two processes.

The agency pointed me to the FDA’s EUA review memo dated 20 Nov 2020 which suggested that the testing was “ongoing.”

The three-year old document stated that “A more comprehensive comparability assessment encompassing additional lots from multiple DP manufacturing nodes is ongoing and the results will be provided to the EUA upon completion of the study.”

When I asked the FDA for access to the “ongoing” results, I was instructed to obtain the information from Pfizer, but the drug company did not respond to my enquiries.

A Freedom of Information request by Nick Hunt of the Daily Sceptic may explain why.

Pfizer promised the regulator that it would compare the safety and immunogenicity of the two processes in participants and report back by February 2021, but it seems those studies were never done.

The FOI stated:

…in October 2020 an exploratory objective was added in the C4591001 study to describe safety and immunogenicity of vaccines produced by manufacturing “Process 1” or “Process 2” in participants 16 to 55 years of age. This exploratory objective was removed and documented in protocol amendment 20 in September 2022 due to the extensive usage of vaccines manufactured via “Process 2”. Thus, this process comparison was not conducted as part of the formal documentation within the protocol amendment.[emphasis added]

Wiseman said, “Given the magnitude of the process change, from my experience in medical product development, these sorts of biological comparability studies would certainly have been expected to be undertaken by Pfizer.”

He added, “the fact that Pfizer was given a free pass indicates a significant lapse in regulatory oversight.”

Kevin McKernan, the genomics expert who made the discovery of DNA fragments in the vaccines earlier this year, says there’s “no incentive” now for Pfizer to carry out this comparative testing. 

“It’s speculation on my part, but I suspect they might’ve seen increased adverse events with the commercial batch and buried the data knowing the train had left the station at that point,” said McKernan.   

“There was no political will to stop vaccinating, and Pfizer probably knew the regulators would let them get away with not testing the commercial batches for the population,” he added. 

*  *  *

Republished from the author’s Substack

https://www.zerohedge.com/medical/fda-shuts-down-enquiries-about-dna-contamination-covid-vaccines

"Our Munich": Israel Plans To Hunt Down Hamas Operatives Living Abroad

 Israel has signaled it is prepared to take the war on Hamas far beyond the confines of Gaza and the West Bank. Fresh words by the country's defense minister have invoked "our Munich" in relation to planned efforts to hunt down notable Hamas operatives abroad. 

"The cabinet has set us a goal, in street talk, to eliminate Hamas. This is our Munich. We will do this everywhere, in Gaza, in the West Bank, in Lebanon, in Turkey, in Qatar," said Ronen Bar, who is the head of Israel's domestic security agency Shin Bet. 

He emphasized, "It will take a few years but we will be there to do it." Israel has long been known to conduct aggressive and high risk assassination campaigns abroad, especially in Iran of late.

The words have outraged Turkey in particular, given it was named in Bar's comments. On Monday Turkish Intelligence warned of "serious consequences" if Israeli agents try to seek Hamas members abroad, or especially on Turkish soil.

The most famous targeted assassination covert op was in response to the 1972 killings of 11 Israeli Olympic team members. Terrorists belonging to the Palestinian Black September had launched an unprecedented attack on the Munich games. Some eight members of the radical group had breached the Olympic compound and entered the two apartments used by the Israeli team, after which they began executing athletes amid a hostage standoff.

From there began a process on the part of Israeli intelligence to hunt down the Munich killers over a period of several years and spanning different countries. Israeli intelligence had dubbed the covert operation - details of which only became known decades later - as the "Wrath of God".

According to a recounting of how the risky Munich response came together...

The clandestine programme was spearheaded by then Mossad chief Zvi Zamir, prime minister Golda Meir and her counterterrorism adviser Aharon Yariv, said historian Michael Bar-Zohar.

Initially, "after Munich, Golda Meir didn't know what to do", Bar-Zohar said. The two security chiefs, both with "the air of university professors", met Meir, the Israeli historian said. "They were timid, well-dressed, and said one thing: 'Now we must destroy Black September'."

The trio, aware it would be nigh impossible to hunt down all members of Black September, instead devised a strategy of "smashing the head of the serpent" by killing the group's leadership, said Bar-Zohar.

"Golda really hesitated," he said. "Should she authorize assassinations throughout Europe and the Middle East?

"She said 'yes'."

Over the next few months, the heads of Black September and their allies from the Palestine Liberation Organization began to die in mysterious circumstances in Rome, Paris and Cyprus.

But Oct.7 was clearly many times worse that the Munich Olympic massacre, with some 1,200 Israelis - most of them civilians - killed. Around 240 hostages were taken, and currently 137 are still captive in Gaza, among them small children, after last week's truce and prisoner swap deal collapsed.

Much of Hamas' political leadership lives abroad, making decisions for the militant group from afar - and often from within the safety of Muslim countries. One famous operation in the recent past was known as the "Dubai job". A high-ranking and founding Hamas member had been killed at his hotel by a group of Mossad assassins dressed as if they were playing tennis.

But the operation was somewhat of a fiasco given how widely the CCTV footage was publicized in the aftermath. Author Ronen Bergman has detailed this and other clandestine killings in his book Rise and Kill First: the Secret History of Israel's Targeted Assassinations. Many targeted killings have also taken place against Iran, where Iranian nuclear scientists have especially been in the crosshairs of late.

https://www.zerohedge.com/geopolitical/our-munich-israel-planning-hunt-down-hamas-operatives-living-abroad

US Water Systems Targeted By Iran-Linked Cyberattacks In Multiple States

 by Tom Ozimek via The Epoch Times (emphasis ours),

Multiple federal agencies are warning that Iran-linked hackers have been targeting U.S. water systems and other industries that use programmable-logic controllers (PLC) made by Israeli firm Unitronics, as the Israel–Hamas war simmers in the background.

Hackers affiliated with the Islamic Revolutionary Guard Corps (IRGC) have engaged in "malicious cyber activity" targeting PLC operational technology devices used in the U.S. water and wastewater systems sector, and in other industries including energy, food, and beverage manufacturing, since at least Nov. 22, the agencies said in a Dec. 1 alert.

The agencies that issued the warning include the FBI, the Cybersecurity and Infrastructure Security Agency (CISA), and the National Security Agency (NSA), with the Israel National Cyber Directorate (INCD) joining in the advisory.

This IRGC-linked cyberattack group (known variously as CyberAv3ngers, CyberAveng3rs, or Cyber Avengers) has been compromising default credentials in Unitronics devices since at least Nov. 22, the agencies said.

After hacking the PLC devices in multiple states, CyberAv3ngers left the following defacement message: “You have been hacked, down with Israel. Every equipment ‘made in Israel’ is CyberAv3ngers legal target.”

The cyber group has claimed responsibility for numerous attacks against critical infrastructure in Israel starting in 2020; it has recently turned its attention to targets in the United States, a key ally of Israel as it battles the Hamas terror group in response to the Oct. 7 attacks against Israel.

One high-profile attack by CyberAv3ngers targeted a water authority near Pittsburgh on Nov. 25, prompting congressional lawmakers to demand an investigation by the Department of Justice (DOJ) and triggering the latest multi-agency warning that other water and sewage-treatment utilities, and other industries, may be vulnerable.

The PLC devices regulate processes including pressure, temperature, and fluid flow, according to Unitronics.

Pennsylvania Water Utility Attacked

A cyberattack by the Iran-linked group on Nov. 25 targeted the Municipal Water Authority of Aliquippa, Pennsylvania, forcing the utility to switch to manual operations; officials said water quality wasn't compromised.

"The affected municipality’s water authority immediately took the system offline and switched to manual operations—there is no known risk to the municipality’s drinking water or water supply," the CISA said in a Nov. 28 notice.

While water quality wasn't affected this time, the agency said that such cyberattacks do have the potential to threaten the ability of water and wastewater systems to provide clean drinking water to residents and to effectively manage wastewater.

The hackers accomplished their attack by exploiting cybersecurity weaknesses, including poor password security and exposure to the internet, according to the CISA. The agency urged water and wastewater facilities to take preventive measures including changing passwords and disconnecting the PLCs from the open internet.

Several Pittsburgh-based cybersecurity firms said that utility companies are more vulnerable to cyberattacks targeting operational technology because many of these systems are dated and monitored infrequently.

"Take a Fortune 500, or any type of large manufacturer or utility—instead of breaking in through their firewalls and trying to get to their data, [hackers have] the ability to try to go in and interfere with their systems," David Kane, CEO of Pittsburgh-based Ethical Intruder, told the Pittsburgh Post-Gazette.

"I think you're gonna see a big rise in that because there's just so few protections on it," he said, adding that an attack on the operational technology side is "very alarming."

In its latest warning, the CISA and the other agencies shared a number of indicators of compromise (IOC), as well as tactics, techniques, and procedures (TTP) associated with the Iran-linked cyber group's operations.

Lawmakers Demand Probe

The cyberattack prompted several congressional lawmakers from Pennsylvania to demand that the Department of Justice (DOJ) launch an investigation into how the foreign hacking group managed to breach a U.S.-based water facility.

"Any attack on our critical infrastructure is unacceptable," U.S. Rep. Chris Deluzio (D-Pa.) said in a post on X. "It poses a threat not only to Western PA, but also the nation."

Mr. Deluzio, along with U.S. Sens. John Fetterman (D-Pa.) and Bob Casey Jr. (D-Pa.) wrote a letter to U.S. Attorney General Merrick Garland on Nov. 28, saying that Americans need to be confident that their drinking water and other basic infrastructure is safe.

“If a hack like this can happen here in western Pennsylvania, it can happen anywhere else in the United States,” the lawmakers wrote.

The attack came less than a month after a federal appeals court decision prompted the Environmental Protection Agency (EPA) to rescind a rule that would have obliged U.S. public water systems to include cybersecurity testing in their regular federally mandated audits.

The rollback was triggered by a federal appeals court decision in a case brought by Missouri, Arkansas, and Iowa, and joined by a water utility trade group.

Unitronics didn't respond by press time to queries as to whether other facilities with its equipment may have been hacked or could be vulnerable.

https://www.zerohedge.com/political/us-water-systems-targeted-iran-linked-cyberattacks-multiple-states

How the New Outbreak in China Is Affecting the US and Other Regions

 The social media images from China are a heart-rending déjà vu with photos of young children connected to intravenous lines receiving fluids from overcrowded hospital waiting rooms.

For a world still reeling from the recent coronavirus pandemic, news from China about a sudden rise in respiratory ailments has prompted understandable concern.

Just 4 years ago, a mysterious respiratory illness started to spread in China (SARS-CoV-2), and a lack of transparency by government officials cost other countries needed time to prepare.

In Beijing, worried parents seeking help for their children are having to wait at least a day, even for emergency care. The Chinese Center for Disease Control and Prevention reported more than 3500 cases of respiratory infection admitted to the Children's Hospital.

In Liaoning Province, almost 500 miles away from Beijing, there are more reports of sick children overwhelming hospitals.

Chinese media blame the outbreak on mycoplasma pneumonia, sometimes called walking pneumonia, which is a bacterial infection that usually causes upper respiratory tract symptoms but can also prompt more serious lung issues and pneumonia.

In the United States, the weekly percent of emergency department visits for children with diagnosed pneumonia was about 2% as of the latest Centers for Disease Control and Prevention (CDC) report November 25, 2023, which is average for this time of year, although the agency is already reporting a slight increase above typical levels for children aged 5-17 years.

Sick Children

Chinese authorities from the National Health Commission held a news conference on November 13, 2023 to talk about the new rise in respiratory illnesses. Colder weather paired with China lifting stringent COVID restrictions has authorities attributing the latest wave of illness to what is sometimes called an immunity gap with an anticipated surge of circulating known pathogens.

But troublingly, a Program for Monitoring Emerging Diseases (ProMed) report noted that many of the children in China were not coughing and didn't really have other symptoms other than a high fever. Some children developed pulmonary nodules.

This has prompted specialists to question whether these new clusters could be evidence of undiagnosed pneumonia caused by a novel pathogen.

Since mid-October 2023, the World Health Organization has monitored data from Chinese surveillance systems showing increases in respiratory illnesses. And on November 22, the United Nations health agency asked China to provide more epidemiologic and clinical information and lab results from these reported cases as well as data about recent trends in circulating respiratory pathogens.

By November 24, China reported no unusual or novel pathogens in the clusters of pneumonia cases.

The CDC has a small office in China that is working with local scientists. Reassuring, perhaps, is the fact that cases are predominantly in children, which seems to point away from this being a novel pathogen. Something new like a never-before encountered pandemic-spurring disease would leave everybody susceptible so cases might cut across age groups more than what we are seeing from these first reports from China.

"We are in touch with our counterparts in China and we believe there is no new or novel pathogen," Mandy Cohen, MD, director of the CDC told the House Committee on Energy and Commerce. "These are related to existing pathogens: COVID, flu, [respiratory syncytial virus (RSV)], and mycoplasma."

Cohen said that her team was able to corroborate this information across other sources, including European Union partners.

Cases in Europe

In Denmark, mycoplasma pneumonia activity is rising across the country, with 541 cases reported last week: triple that of the middle of October 2023.

 

A common bacterial cause of pneumonia is mycoplasma pneumonia, the so-called white lung, being talked about in China. White lung refers to the patches that light up on chest radiographs of those affected by the illness. Another bacterial cause is streptococcus pneumonia and viral causes of pneumonia are very common too, coming from circulating flu viruses, RSV, and SARS-CoV-2, the virus that causes COVID.

Other countries already saw increases in respiratory illnesses after easing pandemic measures like China has now. And in the US, a tripledemic of the flu, RSV, and COVID filled hospitals in multiple states. Today, "COVID is still the primary cause of new respiratory hospitalizations and deaths in the US," Cohen said, "with about 15,000 hospitalizations and 1000 deaths every week."

Macrolides, tetracyclines like doxycycline, and fluoroquinolones are typically the antimicrobials of choice for mycoplasma pneumonia. However, macrolide resistance has been reported worldwide, especially in Asia, where resistance rates of over 90% have been reported in China.

"We're following up through our clinical networks and working with clinicians in China to better understand resistance to antibiotics," Maria Van Kerkhove, PhD, COVID-19 Technical Lead at the World Health Organization told reporters. "It's a problem across the world but is a particular problem in the Western Pacific and Southeast Asia region," she said.

Syra Madad, DHSC, MSc, MCP, CHEP, an infectious disease epidemiologist at Harvard's Belfer Center for Science and International Affairs and the New York City Hospital System, commented that we live in a new world where close monitoring of threats to human health is "essential."

Hospital care to seek treatment is really the last line of very costly defense, she told Medscape Medical News. "Where parents like me and like you have to put our attention is on prevention to make sure we're protecting our children."

We have the tools, she said, "on the front end, we have vaccines and therapeutics, but we have so much more work to do in public health and how we communicate with people so they know how to keep themselves and their loved ones safe."

https://www.medscape.com/viewarticle/999051

J&J gets FDA breakthrough status for TAR-200 in bladder cancer

 Johnson & Johnson's (JNJ) therapy candidate TAR-200 received breakthrough therapy designation from the FDA for the treatment of high risk bladder cancer.

https://seekingalpha.com/news/4043187-jj-gets-fda-breakthrough-status-for-tar-200-in-bladder-cancer

VistaGen Analyst Highlights Potential In Anxiety Treatment

 William Blair initiated coverage on VistaGen Therapeutics Inc VTGN, a clinical-stage biopharmaceutical company focused on developing next-generation treatment options for social anxiety disorder (SAD) and other mental health conditions. 

The lead product Fasedienol (PH94B), is an intranasal pherine and is in late-stage development for SAD, which affects about 10% of the U.S. population, with 6 million adults being treated by a physician.

Aside from one negative Phase 3 study, PALISADE-1, which was impacted by the pandemic, William Blair says fasedienol has shown strong proof of concept.

The analysts Tim Lugo, Lachlan Hanbury-Brown, and John Boyle note that the market underappreciates the FDA’s concerns about benzodiazepine abuse, and the lack of abuse potential for fasedienol in the large anxiety market suggests that even a small penetration into this large market would lead to a blockbuster product. 

The analyst initiates with an Outperform rating and estimates a fair value for shares of $14.

VistaGen remains an overlooked, undervalued name with differentiated assets in large mood disorder markets, William Blair writes.

Fasedienol, itruvone, and VistaGen’s other pherines (PH80, PH15, and PH284) address major markets across mental health crisis to women’s health. 

https://www.benzinga.com/analyst-ratings/analyst-color/23/12/36075808/undervalued-vistagen-therapeutics-analyst-highlights-potential-in-anxiety-treatment

Why Newly Listed Korro Bio Shares Are Gaining

 H.C. Wainwright initiated coverage on Korro Bio Inc KRRO, a biotech company developing genetic medicines focused on editing ribonucleic acid (RNA) to treat various diseases.

Recently, Korro Bio went public via a reverse merger with Frequency Therapeutics Inc. in an all-stock merger transaction. 

Approximately $170 million post-transaction cash is expected to fund operations into 2026.

The analysts Mitchell S. Kapoor and Raghuram Selvaraju initiated with a Buy rating and a price target of $100 per share.

H.C. Wainwright notes that Korro's core technology, Oligonucleotide Promoted Editing of RNA (OPERA), leverages native biology, whereby a naturally occurring enzyme makes a targeted base edit in the RNA sequence, resulting in desired protein translation and function.

Korro's OPERA platform enables a broad pursuit of indications with an initial focus on six potential programs that either correct the mutation or create de novo protein variants that can address the disease.

The analyst highlights the fact that Korro's preclinical data was generated using a lipid nanoparticle that was utilized in the approved RNA interference (RNAi)-based therapeutic, Alnylam Pharmaceuticals Inc's ALNY Onpattro (patisiran) indicated for polyneuropathy in people with hereditary transthyretin-mediated amyloidosis, a rare disorder.

The company's lead program is Oligo A for alpha-1 antitrypsin deficiency (AATD), a rare genetic disorder that primarily affects the lungs and liver, leading to lung conditions and liver disease.

https://www.benzinga.com/analyst-ratings/analyst-color/23/12/36075434/why-newly-listed-korro-bio-shares-are-gaining-today