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Wednesday, November 8, 2023

Sperry: Hamas Ally CAIR Has Been Operating With Impunity Inside America For 30 Years

  by Paul Sperry via RealClear Wire,

After Hamas massacred 1,400 men, women and children in Israel last month, FBI Director Christopher Wray warned that the terror group “and its allies” could inspire attacks on Americans "here on our own soil." He also told the Senate that the FBI is conducting “multiple, ongoing investigations” into people affiliated with the U.S.-designated terrorist group.

What Wray didn’t say is that the FBI has been investigating Hamas’ biggest ally in America for the past 30 years – without filing any charges. Launched in 1994 as a secret front organization to support Hamas, according to declassified FBI wiretap transcripts and FBI testimony, the Council on American-Islamic Relations has, in the decades since, become an accepted member of Washington’s lobbying community. The New York Times and other influential newspapers routinely describe CAIR as a “Muslim civil rights and advocacy organization.”

Although it has not repudiated its support for Hamas – which is committed to the destruction of Israel and the Jewish people – CAIR was enlisted by the Biden administration in May to take part in a White House initiative to fight antisemitism.

On Oct. 7, the day Hamas terrorists butchered 1,400 Jews, including 33 Americans – raping many and abducting some 240 others to Gaza from southern Israel – CAIR’s national executive director, Nihad Awad, delivered an anti-Israel message in Arabic which seemed to justify what Hamas did. Translated into English, it read: “All Arab peoples must go out on Sunday, Oct. 8 – and every day – in demonstrations in support of the Palestinians and in rejection of normalization with the occupier and the apartheid regime [Israel].”

On Saturday afternoon, CAIR helped rally more than 100,000 Muslims in D.C. to instead condemn Israel for supposedly carrying out “genocide” in Gaza in response to the Oct. 7 attacks. Multiple speakers called for the destruction of Israel – and, by implication, the Jewish people there – by demanding Palestinians take all the lands “from the [Jordan] river to the [Mediterranean] sea.”

Awad was front and center, delivering a fiery speech bashing Israel and President Biden for not calling on Israel to stop bombing Hamas targets inside Gaza, which he called “genocidal attacks.” He threatened to hurt Biden at the ballot box in 2024 if he does not urge a ceasefire.

“We have discovered the language that President Biden understands: ‘No ceasefire, no votes,’” Awad bellowed to the crowd, which erupted into a chant repeating his words. “No votes in Michigan, no votes anywhere if you do not call for a ceasefire now. He then led a chant: “Free, free Palestine!”

Also, Awad promised to provide legal support to Muslim Americans who protest in support of Palestine. “We are with you,” he said. “The people of Gaza rely on your voices and activism.”

Protesters later marched on the White House, where they defaced the white brick gate of the Executive Mansion with red paint symbolizing the blood of Gazans who have died from the Israeli army's counterstrikes. Awad is on record declaring his support for Hamas. At Barry University in 1994, for example, he said: “I am in support of the Hamas movement.”

CAIR did not respond to requests for comment, but without addressing specifics, it has previously argued it “is not a ‘front group for Hamas.’” The FBI and White House declined to comment.

While CAIR is now a mainstay of American politics – headquartered just three blocks from the U.S. Capitol, with 35 offices across the country – its history reveals its close connections with terror groups such as Hamas, as detailed in the 2009 book this reporter co-authored with counterterrorism expert P. David Gaubatz, “Muslim Mafia: Inside the Secret Underworld that's Conspiring to Islamize America.”

The story began in the Palestinian refugee camp in Jordan in the 1960s, where Awad and a co-founder of CAIR, Omar Ahmad, were born. Both men eventually came to the United States for university studies. By 1992, Awad was a key member of the so-called Palestine Committee in America, which helped finance Hamas. According to a 1992 letter from the Gaza Strip, Hamas asked the Committee for money to buy “weapons, weapons, our brothers.” The letter continued: “The meaning of killing a Jew for the liberation of Palestine cannot be compared to any jihad on earth.”

Around the same time, the FBI was eavesdropping on several Hamas leaders in connection with terrorist activities, which produced tapes documenting the incarnation of CAIR in 1993. At a secret meeting that October, Omar Ahmad called to order the Hamas summit in Philly at a Courtyard by Marriott hotel in Philadelphia to discuss the formation of a new front organization to support their “movement” in America. Awad also attended the meeting.

According to court testimony by FBI agent Lara Burns, who runs a major counterterrorism program for the bureau, Ahmad, Awad, and the other leaders who gathered there hatched a scheme to disguise overseas payments to Hamas terrorists and their families as charity. FBI wiretaps also recorded them stating the need to deceive Americans about the true aims of their planned American front group as Hamas launched a campaign of terror attacks on Israel known as the “Intifada.”

They compared the deception to the “head fake” in basketball, where a shooter tricks an opponent guarding him into moving in a different direction. The group, according to the wiretap transcripts, envisioned an “alternative” organization whose pro-Palestinian stripes were “not very conspicuous.” Burns testified CAIR was what they had in mind. During the talks, they tried to mislead any authorities who might be listening in by referring to Hamas as “Samah” – Hamas spelled backward.

Ahmad would co-found CAIR in 1994, hiring Awad as executive director that same year. Both men have expressed hatred toward Israel and resentment toward their adopted country for helping fund and arm the Jewish nation.

Burns testified during the 2008 terrorism trial of a charitable front for Hamas known as the Holy Land Foundation. It was the largest terror funding case in U.S. history. As part of the court filings, the Justice Department included CAIR on a list of co-conspirators underwriting Hamas terrorism – though CAIR and its founders were never indicted in the case. The HLF, busted up as the main fundraising arm of Hamas in America, commingled funds, assets, and personnel with CAIR, according to tax records and court documents.

“CAIR has been identified by the government as a participant in an ongoing and ultimately unlawful conspiracy to support a designated terrorist organization [Hamas] – a conspiracy from which CAIR never withdrew,” said former Assistant U.S. Attorney James Jacks, who was the lead prosecutor in the case.

A federal judge agreed. "The government has produced ample evidence to establish the associations of CAIR with Hamas," then-U.S. District Judge Jorge Solis wrote in a July 2009 ruling.

A number of FBI counterterrorism agents were frustrated that CAIR’s national office and executives were never charged in the conspiracy, although the founder of CAIR’s Texas chapter was sentenced to prison. They said politics intervened. After 9/11, they said FBI headquarters viewed CAIR as a link to the Muslim community through which they might obtain tips about terror threats to the homeland. Brass even invited CAIR officials up to the executive suites located on the 7th floor of the Hoover building to discuss outreach policy.

“We said, ‘These are the bad guys, this is Hamas. What are you doing?’” former FBI Special Agent John Guandolo said, describing how he and other agents protested the special treatment afforded CAIR.

After CAIR was named an unindicted co-conspirator in the HLF’s criminal scheme to funnel more than $12 million to Hamas terrorists, the FBI finally disengaged from the group. The agency stopped conducting formal outreach with CAIR’s national office until, it said, it could resolve issues with Awad and other worrisome leaders.

“Until we can resolve whether there continues to be a connection between CAIR or its executives and Hamas, the FBI does not view CAIR as an appropriate liaison partner,” then-Assistant FBI director Richard Powers said in a 2009 letter to the Senate.

But some investigators say the FBI should have shut down the group, not just the outreach program, issuing search warrants and conducting more intrusive surveillance, which they say would have allowed the government to run the Hamas front out of business.

“CAIR is the leading Hamas entity inside the United States, and the FBI has taken no action to prosecute them,” said Guandolo, who helped lead several major counterterrorism probes at the Washington field office after 9/11. He explained that “politically correct” FBI leadership is hesitant to go after a minority religious group and is overly sensitive to charges of “Islamophobia” often leveled by CAIR against its critics.

The FBI’s reluctance to roll up the Hamas front has pushed private investigators to take matters into their own hands. In 2008, a counterterrorism specialist led a team of investigators in a daring undercover operation of CAIR that included infiltrating its national headquarters located on New Jersey Avenue in Washington, D.C., near the Capitol Building. Working as interns, the investigators, who posed as recent converts to Islam wearing traditional Muslim garb, secretly video-recorded conversations with CAIR officials. During the six-month operation, they also intercepted more than 12,000 pages of documents CAIR intended to shred as trash. The evidence, which was turned over to the FBI, is documented in “Muslim Mafia,” which also features an appendix with several key internal CAIR documents reprinted.

Among other things, the book revealed that CAIR employed violent Islamic terrorists, and then supported the terrorists behind the scenes even after they were convicted. It also uncovered an influence operation against members of key homeland security committees in Congress that included planting CAIR operatives in congressional offices. Internal CAIR documents laid out a plan to elect dozens of pro-Hamas Muslims to Congress. CAIR even started holding Muslim prayer sessions each Friday in the basement of the Capitol.

“Muslim Mafia” also traced the deeper roots of Hamas back to the secretive Muslim Brotherhood, the pro-jihad group founded in Egypt that built a sophisticated network of Islamic nonprofits inside the U.S. several decades ago. The book documented how Muslim Brotherhood leaders wrote a secret blueprint for “destroying [America] from within … so that it is eliminated and Allah’s religion is made victorious over all other religions.” FBI investigators discovered the manifesto stashed in a sub-basement of a Brotherhood leader’s home in Annandale, Va., after raiding his residence as part of a terrorism probe.

Several alarmed Republican members of Congress held a press conference about the book’s findings, warning a Hamas terror front group was infiltrating Congress.

Besides exposing Hamas’ political arm in America, the book exposed the inner workings of the broader anti-Israel lobby, which includes several leftwing groups aligned with CAIR. This lobby is now revealing itself in the wake of Israel’s own 9/11.

“The seeds for 9/11 were planted in 1948,” according to a draft of a “Proposed Muslim Platform” found at CAIR’s headquarters. “A resolution of the Israeli-Palestinian conflict needs to be based on recognizing and correcting the harm that was done to the Palestinians since 1948,” when the United Nations partitioned land for Israel.

Guandolo said Hamas proved just how dangerous it is on Oct. 7. He warned that the terrorist group has already penetrated American society, and CAIR is the tip of the spear.

“Currently, CAIR is directing efforts at the ground level across the United States with organizations known for violent extremism,” he added in a recent interview with RealClearInvestigations. “Again, the FBI is doing nothing to adhere to their oaths of office and protect the American people.”

https://www.zerohedge.com/geopolitical/sperry-hamas-ally-cair-has-been-operating-impunity-inside-america-30-years

FDA is investigating deaths and hospitalizations caused by fake Ozempic: reports

 The Food and Drug Administration is investigating several hospitalizations and deaths potentially linked to counterfeit semaglutide drugs, such as Ozempic, according to multiple reports.

At least three Americans have been hospitalized after injecting themselves with suspected counterfeit products, CBS News reported.

The hospitalizations being investigated are allegedly among the 42 cases reported to the FDA’s Adverse Event Reporting System that cite the use of counterfeit semaglutide — in which its game-changing ingredient is being swapped with a synthetic version of insulin.

However, cases of adverse effects sent to FAERS have not necessarily been medically confirmed and only some specifically mentioned Ozempic, including one of the three hospitalizations being investigated.

More than half of the cases reported are classified as “serious,” which may include deaths.

Two women allegedly died after suffering from blood clots caused by the fake meds, the Daily Mail reported.

Symptoms suffered by duped patients included seizure, skin discoloration, bruising and liver disorder, according to the British tab.

All the cases were submitted to the FDA by Novo Nordisk, the manufacturer of Ozempic.

“In close collaboration with the FDA, we have taken measures to create awareness of the potential for counterfeit products,” a representative from Novo Nordisk told The Post. “We have provided communications to a number of stakeholders, including wholesalers and pharmacists, to ensure they are aware of the situation and also able to identify a potential counterfeit semaglutide injectable product.”

Bogus versions of the diabetes drug have been found for sale on Facebook groups and, even more worryingly, have also made their way onto pharmacy store shelves.

Novo Nordisk warned consumers earlier this summer that counterfeit versions of the drug were purchased in some retail pharmacies around the country.

An FDA spokesperson has assured that all reports are being investigated and an “appropriate regulatory response” will be made. “The FDA remains vigilant in protecting the US drug supply from these threats,” the agency told The Post in a statement.

Ozempic, a semaglutide designed to improve the quality of life for diabetics, has spawned a weight loss craze across the US as patients — almost accidentally — found they were shedding pounds at rapid rates after being put on the drug. Now, non-diabetics are clamoring for the accidental diet pill, leading to shortages, reports of dangerous side effects and fraud.

https://nypost.com/2023/11/08/lifestyle/fda-is-investigating-deaths-and-hospitalizations-caused-by-fake-ozempic-reports/

US strikes facility in Syria amid attacks on American troops

 U.S. forces on Wednesday struck a weapons storage facility in eastern Syria used by Iran and its proxies after continued attacks against American troops in the region.

President Biden directed the “self-defense strike” by two U.S. F-15s on the facility used by Iran’s Islamic Revolutionary Guard Corps (IRGC) and affiliated groups, Defense Secretary Lloyd Austin said.

 

“This precision self-defense strike is a response to a series of attacks against U.S. personnel in Iraq and Syria by IRGC-Quds Force affiliates,” Austin said in a statement.

 

“The President has no higher priority than the safety of U.S. personnel, and he directed today’s action to make clear that the United States will defend itself, its personnel, and its interests.” 

 

U.S. forces in Iraq and Syria have been attacked at least 42 times since Oct. 17 — including two in the last 24 hours — with one-way drones and rockets. At least 46 service members have been injured in these assaults, which defense officials have blamed on Iran.

 

In addition, an American MQ-9 Reaper surveillance drone was shot down off the coast of Yemen on Wednesday by the Iranian-backed Houthis, a defense official confirmed. 

 

Attacks on American troops in the region have been consistent following the start of the Israel-Hamas war, a conflict that has created unrest in the Middle East. 

 

Earlier determent efforts include a U.S. strike on an Iranian weapons storage facility and an ammunition storage area in eastern Syria in late October. 

 

The Pentagon has also deployed at least 1,200 troops to the region along with a Terminal High Altitude Area Defense (THAAD) battery and Patriot battalions. 

 

In addition, Washington has sent two aircraft carrier strike groups to the region and a nuclear-powered submarine.  


https://thehill.com/newsletters/defense-national-security/4300837-us-strikes-facility-in-syria-amid-attacks-on-american-troops/

COVID-19 Lockdowns Contributed To 'Collective Trauma' Among Americans: Psychologists

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

The United States is still reeling from the effects of COVID-19 lockdowns and other aspects of the COVID-19 pandemic as Americans have suffered a "collective trauma," the American Psychological Association (APA) has said, citing a study.

While the national health emergency caused by the COVID-19 outbreak officially came to an end on May 11, in some ways the country hasn't returned to "normal." according to the organization.

The APA concluded in the results of its survey, released on Nov. 1, that there are "signs of collective trauma among all age cohorts" in the United States.

The COVID-19 pandemic created a collective experience among Americans. While the early-pandemic lockdowns may seem like the distant past, the aftermath remains,” Arthur C. Evans Jr., the organization's CEO, said in a statement.

The study found that adults between the ages of 34 and 44 reported the biggest surge in chronic health conditions since the pandemic, rising to 58 percent in 2023 from 48 percent in 2019.

The same age group also experienced the biggest jump in mental health illnesses, chiefly anxiety and depression. These rose to 45 percent this year from 31 percent in 2019, according to the study.

Chronically elevated levels of stress create risks for various mental health challenges and wear down the immune system, according to the APA. The association noted that the data suggest that long-term stress sustained since the outbreak of the COVID-19 pandemic has had a significant impact on Americans' well-being.

We cannot ignore the fact that we have been significantly changed by the loss of more than one million Americans, as well as the shift in our workplaces, school systems, and culture at large," Mr. Evans said. "To move toward posttraumatic growth, we must first identify and understand the psychological wounds that remain.”

Chronic stress can cause inflammation, breaking down the immune system and raising the risk of all sorts of ailments, including stroke and heart disease, the APA warned.

The study is the latest that suggests that the heavy-handed response to the outbreak, which included school closures, business shutdowns, and near-universal mask-wearing, has had a negative effect on people's physical and mental health.

Child Gun Deaths Rise Sharply

Recent research on child gun deaths adds heart-wrenching evidence to the growing pile of data suggesting that COVID-19 lockdowns and other restrictions had a devastating effect on society.

The study, authored by researchers from Boston Children’s Hospital and published on Oct. 5 in a journal of the American Academy of Pediatrics, found that injury-related deaths among children rose sharply during the pandemic years 2020–21.

The spike in pediatric fatal injuries was driven by drugs and injuries involving firearms.

In 2021, when lockdowns and other COVID-19 restrictions were pervasive, more child homicides (2,279) and suicides (1,078) by gun were recorded than in any year since 1999, according to the study.

Some see a clear causal link between the explosion in child gun deaths and pandemic lockdown policies, which other studies have linked to a variety of negative outcomes, including delayed health treatments, learning loss, and mental health crises.

“Due to lockdowns and other misconceived pandemic policies, child gun deaths in the United States exploded exponentially in 2020,” Kevin Bass, a researcher and doctoral student in medicine, wrote in a post on X, formerly Twitter.

While the study shows that firearm-related homicides began rising in 2018, Mr. Bass said that it’s “very clear that the huge leap to record levels occurred between 2019 and 2020, which is when lockdowns happened.”

The study’s findings dovetail with an April report from the Pew Research Center, which found that the number of children and teenagers killed by gunfire surged by 50 percent between 2019 and 2021.

Some studies have identified lockdowns as contributing to jumps in suicides, mental health crises, learning loss, and delayed health treatments.

“Our results show that major non-pharmaceutical interventions—and lockdowns in particular—have had a large effect on reducing transmission,” wrote the authors of the study backing restrictive measures, although the research didn't evaluate any other unintended impacts of the measures.

However, one recent study that looked at a wide array of research into lockdowns concluded that such measures can be an effective tool in controlling the COVID-19 pandemic but only if “long-term collateral damage is neglected.”

“The price tag of lockdowns in terms of public health is high: by using the known connection between health and wealth, we estimate that lockdowns may claim 20 times more life years than they save,” the study’s authors wrote.

The authors also said that what deserves a “special and urgent analysis” is the question of “to what extent, why, and how the dissenting (disapproved by healthcare officials) scientific opinions were suppressed during COVID-19.”

“Suppression of ‘misleading’ opinions causes not only grave consequences for scientists’ moral compass; it prevents the scientific community from correcting mistakes and jeopardizes (with a good reason) public trust in science," they wrote.

https://www.zerohedge.com/medical/covid-19-lockdowns-contributed-collective-trauma-among-americans-psychologists

Unexpected Battle Between Vaccines And The COVID Virus

 by Yuhong Dong via The Epoch Times (emphasis ours),

Since the unprecedented COVID-19 global pandemic that started in January 2020, humans have been in a constant battle with the SARS-CoV-2 virus.

A series of vaccine versions have been developed and administered globally, beginning in January 2021 when an mRNA vaccine based on the original Wuhan strain was implemented. Subsequently, a bivalent mRNA vaccine was developed based on the Omicron offspring. Currently, the most updated version is based on XBB.1.5 and is ready to be injected into people's arms.

Bivalent vaccines contain two different components. One component is to protect us against the original viral strain, while the other targets the most recent variants.

The vaccine is based on the gene code of a known virus, whereas the lead time for vaccine development normally takes an average of 10 years. Even with the current "green-light" policies for COVID-19 vaccines, it takes almost one year for the first generation to launch and a couple of months for the second and third generations.

However, due to the basic survival skills of SARS-CoV-2, the virus is always mutating in order to escape from a vaccine. Even before a vaccine is ready to launch, there are always a few mutants that have already found a way to escape from the antibodies induced by the sluggish vaccine, creating the next wave.

Regardless, the unprecedented speed of vaccine development won't be able to compete with the speed of viral mutation, as the virus is always taking the lead and will be one step ahead of the vaccine.

This is why even the top scientists cannot predict how the virus will mutate and when the next wave will occur.

SARS-CoV-2 Variants

From 2020 to early 2021, a number of major SARS-CoV-2 variants have appeared: Alpha (B.1.1.7), Beta (B.1.351), Gamma(P.1), and Delta (B.1.617.2).

Not including those old variants, once Omicron (B.1.1.529) was first reported in South Africa in November 2021, it quickly evolved into a few sister lineages: BA.1, BA.2, BA.4, BA.5XBB.1.5EG.5, and HV.1, which each took the stage, one after the other within an interval of a couple of months.

  • BA.1 and BA.2: first detected in February 2022.
  • BA.4 and BA.5: first detected in May 2022.
  • XBB.1.5 (Kraken): an offspring of two BA.2 sublineages first detected in October 2022.
  • BA.2.86 (Pirola): first detected in 2023 and is currently being monitored.
  • EG.5 (Eris): first detected in Feb 2023, peaked in October, and is now declining.
  • HV.1: first detected in July 2023, has taken the lead in the United States at the end of October 2023.

The fierce battle between the virus and human technology has become a marathon. With each generation of vaccine development, who were the winners?

First Generation Vaccine: Delta Emerged, Creating Global Havoc

In January 2021, the original mRNA monovalent vaccines developed by Pfizer and Moderna and based on the old Wuhan strain were launched at a rocket-like speed.

In June 2021, when more than 50 percent of the U.S. population had received two doses of these vaccines, the stage was set for various mutants to take over, including the well-known alpha and delta variants.

A key mutation in spike protein called N501Y, which can escape from vaccine protection, was discovered in alpha. It was also found in two other major variants prevalent during that time and significantly increased in the rate at which it spread.

Shortly thereafter, Delta (B.1.617.2) emerged and presented even more enhanced transmissibility and vaccine escape ability with its intriguing spike protein double mutations of L452R and E484Q, refreshing the viral spreading and escaping records. It was designated as a "variant of concern" by the World Health Organization (WHO) on May 11, 2021.

These double mutations in the spike protein cause the vaccine-induced antibodies to significantly lose their ability to bind to delta, resulting in immunological evasion and causing major global havoc.

The increased binding affinity caused by delta makes it much easier to replicate in human cells. It was reported that patients infected with delta had a viral load 1000 times greater than patients with the original strain. It's also been able to spread twice as fast as the original SARS-CoV-2 virus.

In July 2021, preliminary data from Israel showed that Pfizer's vaccine efficacy was significantly reduced at five and six months after vaccination to 44 percent and 16 percent, respectively.

In a July 2021 outbreak in Massachusetts, 74 percent of breakthrough infections occurred in fully vaccinated persons, and the delta variant was detected in 90 percent of them.

The first round of the battle between the vaccine and the virus concluded with an overwhelming vaccine failure when the first generation of the COVID-19 mRNA vaccine met the unexpected delta variant.

Vaccine Versus Virus: The First Battle Round

Vaccine: Monovalent.

Result: The vaccine failed.

Time lapsed: Seven months from the first monovalent vaccine launched in January 2021 until the dominant delta wave in July 2021 in the United States.

Since then, a concern regarding the vaccine strategy of generating vaccine escape variants has been raised by scientists, including researchers from Michigan State University.

Second Generation Vaccine: XBB.1.5 Won

People continued to witness the declining effects of the original vaccine against delta, even after boosters were widely administered. The government continually stressed that the original vaccines had sufficient efficacy, one time after another.

Almost all of Omicron and its subvariants have developed specific mutations that have made them spread more quickly while evading our immune response. It has been clearly defined as an immune escape strain according to this Nature review.

A surprising virus, Omicron (B.1.1.529) surged more quickly than any previous strain and completely took over by April 2022. This emergence of hypermutated, increasingly transmissible Omicron variant significantly threatened the vaccine strategy.

It harbors multiple amino acid mutations in the spike (including Q498R and N501Y), which significantly enhance binding to the ACE2 receptor. It has also altered the cell entry pathway which further contributes to its ability to escape from vaccine protection.

In mid-2022, BA.4 and BA.5 lineages of Omicron were the dominant COVID-19 variants in the United States and were predicted to circulate in the second half of 2022.

Thus, Pfizer and Moderna quickly took the initiative to develop bivalent boosters based on the original strain from Wuhan and Omicron BA.4 and BA.5. They made it within another miraculously short time frame of just a few months.

On August 31, 2022, the FDA approved the bivalent booster shots of COVID-19 mRNA vaccines designed to target the Omicron subvariants BA.4 and BA.5, with Pfizer only providing the data on eight mice.

However, Omicron keeps quickly changing, splitting into even more diversified subgroups. Soon after the new bivalent vaccine was distributed, BA.4 and BA.5 became history.

A new variant XBB.1.5 began appearing in October 2022 and reached its peak in April 2023. It combines two descendent lineages (BA.2.10.1 and BA.2.75) of Omicron. The featured new spike protein mutation (F486P) leads to increased transmissibility and significant escape from the vaccine.

Not surprisingly, the antibody levels to XBB.1.5 in bivalent mRNA-boosted individuals declined significantly to pre-booster levels after only three months. The bivalent booster vaccine effectiveness against COVID-19-associated hospitalization declined to as low as 24 percent at six months post-vaccination, according to CDC data collected from September 2022 to April 2023.

The second round ended when the second generation bivalent mRNA vaccine encountered the XBB.1.5 starting in April 2023.

Vaccine Versus Virus: The Second Battle Round

Vaccine: Bivalent mRNA.

Result: The vaccine failed.

Time lapsed: Five months after the bivalent booster vaccine launched in September 2022 and was utilized until the U.S. dominant wave of XBB.1.5 in January 2023 emerged.

Third Generation Vaccine: Doomed to Fail

As of September 2023, the Pfizer-BioNTech and Moderna mRNA vaccines have been reformulated—for the third time—this time based on XBB.1.5, which is the great-grandchild of Omicron. This latest booster recommendation applies to all individuals, regardless of previous COVID-19 vaccination history.

However, one month before the 3.0 vaccine was approved, the dominant virus had already changed from XBB.1.5 to EG.5—the "Eris" variant, which spreads faster and has a stronger ability to escape from the XBB.1.5 vaccine.

Vaccine Versus Virus: The Third Battle Round

Vaccine: XBB.1.5 mRNA.

Result: Vaccine doomed to fail.

Time lapsed: Less than one month from the XBB.1.5 booster vaccine launch in October 2023 to the U.S. dominant wave of vaccine escape by EG.5 or other cousin variants in October 2023.

Omicron continues to change from XBB to JN, HK.3, EG.5, and  HV.1—all belonging to the huge and diversified Omicron family.

EG.5, carrying an additional F456L mutation, is significantly more resistant to neutralization by the sera from vaccinated people. That means even the most recent version of the COVID-19 vaccine based on XBB.1.5 is going to lose its protection with EG.5. Since the risk of breakthrough infection remains high, the WHO listed EG.5 as a "variant of concern" in early August.

While HV.1 shares almost all spike mutations that EG.5 carries, it took on a surprising additional mutation (L452R) from a remote ancestor delta variant in 2011, which had normally disappeared in the omicron variant. HV.1 can further escape the XBB.1.5-based vaccine-induced immunity and is even more evasive than EG.5.

The same detour trick of HV.1 is also used by JN.1 coming on the scene in August 2023. It gains an additional L455S mutation, switching from the XBB sublineage to BA.2.86 (Pirola).

The HK.3 virus has played a novel trick. It has two mutations in the adjacent spike 455 and 456 positions (L455F and F456L), thus called a "FLip." Together, this virus binds even more tightly to ACE2 and is taking off slowly in Brazil and Spain.

Both HK.3 (FLip) and JN.1 present even lower binding affinitiesmeaning the vaccine is even less effective than the current version, raising further concerns over vaccine strategy.

Despite the extraordinary speed of vaccine development against COVID-19 and the continued mass vaccination program, the never-ending emergence of new SARS-CoV-2 variants threatens to significantly overturn the vaccine's intended effects.

This is a tiring battle between vaccines and the virus. The winners and losers are clear. The microscopic tricks utilized by the SARS-CoV-2 virus variants are far superior to the vaccines' unproven technology.

Alerts have been raised and major concerns have been discussed by scientists as early as 2021 in top-ranked journals including The Lancet and Nature in addition to Nature ReviewseBioMedicine (part of The Lancet Discovery Science), and other publications through 2023.

The common view is that the pressure exerted on viruses from repeated vaccination programs serves as a primary driver of the diversified variants of SARS-CoV-2.

If humans continue to develop vaccines based on these emerging new variants, there will continue to be repeated failures. How many more failures will it take to realize that all of these vaccine efforts have been in vain?

It is a time for rational deliberation to pause to reflect on finding the root cause of the viral infection.

We already have a dynamic shield of protection against serious viral attacks—our natural immunity. Only by facing our own innate immunity will the virus find its tricks useless.

https://www.zerohedge.com/medical/unexpected-battle-between-vaccines-and-covid-virus

Atara MS therapy misses primary endpoint in Phase 2

 Primary Endpoint of Confirmed Disability Improvement at 12 Months Not Achieved

Company to Further Analyze Data and Evaluate Strategic Options for ATA188 Program with Focusing of Resources and Planned Expense Reductions Expected to Extend Cash Runway Beyond Q3 2025

Allogeneic CAR-T Portfolio Advancing with Several Catalysts Anticipated in the Next 18 Months

https://www.businesswire.com/news/home/20231108902565/en/

BioNTech flashes the cash, adding tumour drug in $1bn deal

 Fresh from slashing its predictions for COVID-19 vaccine sales this year, mRNA specialist BioNTech has used some of its extensive cash reserves to bolster its pipeline in oncology.

The German biotech has signed a $1 billion-plus deal with China’s Biotheus, which includes $55 million upfront, to claim rights to a bispecific antibody for solid tumours in all markets outside Greater China.

The drug – codenamed PM8002 – consists of an antibody that targets both PD-L1, a well-established cancer immunotherapy target, and VEGF-A, a protein involved in the growth and spread of solid tumours.

Biotheus said in a statement that PM8002 is currently being tested in phase 2 studies in China to evaluate the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in patients with advanced solid tumours.

The Zhuhai-based company reported data at this year’s ASCO and ESMO conferences that showed a “positive safety profile and encouraging antitumor activity, presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumour microenvironment.”

The deal comes as BioNTech is sitting on top of a pile of windfall cash generated from sales of Pfizer-partnered COVID-19 vaccine Comirnaty over the last couple of years, although, it is facing a sharp retraction in revenues now that the market for COVID jabs has transitioned from a government-led to a traditional private commercial model.

BioNTech said yesterday that it expects to generate around €4 billion ($4.3 billion) in revenue from COVID-19 vaccine revenue for the full year, €1 billion less than forecast earlier in the year and well short of the almost €19 billion it recorded from the business in 2022.

The biotech has made mRNA vaccines for other infectious diseases, as well as cancer therapeutics, the main focus of its R&D, and said in its third-quarter results update that it is expecting to start multiple potentially registrational late-stage oncology trials over the next 18 months.

Those include a phase 3 study of BNT323, a HER2-targeting antibody-drug conjugate in HER2-low metastatic breast cancer, and phase 2 trials for cancer vaccine BNT122 (autogene cevumeran) in pancreatic ductal adenocarcinoma (PDAC), CTLA4-targeting antibody BNT-316 (gotistobart) in prostate cancer, and PD-L1x4-1BB bispecific antibody BNT311 in ovarian cancer.

“Our strategy focuses on assembling a diverse toolbox of complementary technologies to deliver novel therapies, aiming to improve the standard-of-care for cancer patients,” said Professor Ugur Sahin, BioNTech’s chief executive and co-founder.

https://pharmaphorum.com/news/biontech-flashes-cash-adding-tumour-drug-1bn-deal