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True cost of Dems’ plans: $7.5 trillion and a lot of gimmicks

After months of criticizing Sens. Joe Manchin and Kyrsten Sinema for balking at the original $3.5 trillion price tag, congressional Democrats are finally accepting reality and paring President Biden’s social welfare package to between $1.5 trillion and $2 trillion over the decade. 

Does this mean they are responsibly removing the bill’s worst provisions and crafting fiscally sustainable legislation? Of course not! 

Instead, welcome to the gimmick Olympics, where progressives are using classic accounting tricks to hide the true cost of the bill.

Instead of producing legislation that truly costs $2 trillion over the decade, lawmakers are crafting as much as $4 trillion worth of new initiatives, but simply using fake expiration dates to score only a few years of each proposal. The idea is to create new federal programs, hook the constituencies on new federal benefits, and then assume that future Congresses and presidents will not dare to allow them to expire. Those assumed extensions will then blow up the cost far above today’s $2 trillion sticker price.

Sen. Joe Manchin and Sen. Kyrsten Sinema have spent months attempting to get President Joe Biden to lower the cost of his reconciliation bill earning them the ire of constituents and other Democrats.
Sens. Joe Manchin and Kyrsten Sinema have spent months attempting to get President Biden to lower the cost of his reconciliation bill, earning them the ire of constituents and other Democrats. AP Photo/Jacquelyn Martin

For example, the March stimulus law temporarily expanded the child tax credit from $2,000 to $3,000 per child (and $3,600 for children under the age of 6), and expanded eligibility to higher incomes. Democrats have made clear that they want this policy made permanent at a cost of $1.3 trillion over the decade. Yet the initial reconciliation proposal expanded the policy for just four years, and now the White House is calling for just a one-year extension — effectively hiding nearly $1.2 trillion in upcoming costs. Congress already renews a small number of tax cuts each December, and the child credit will simply become another annual extender.

But the gimmick Olympics do not stop at the child credit. The White House has reportedly proposed three- to four-year expiration dates for other initiatives such as paid family leave, Medicaid expansion and new ObamaCare subsidies. A proposed new child care program — which a study by the left-wing People’s Policy Project shows could raise child care prices by $13,000 per year — would reportedly phase in slowly and expire after a few years. On the other side of the gimmick window, a new Medicare dental benefit would be delayed until 2028, and then have its costs jump once outside the 10-year scoring period.

Most cynical of all is the Democrats’ maneuver on the $10,000 cap on the state and local tax (SALT) deduction. The $10,000 cap is set to expire at the end of 2025, but House Democrats want to eliminate it immediately. So to “pay for” that immediate $90 billion-per-year tax cut, Democrats would actually impose a new SALT cap beginning in 2026 — count that future revenue as an offset — and then quickly cancel the tax before it ever goes into effect. In other words, they are creating entirely fake future policies in order to count the fake savings today.

President Joe Biden continues to lobby Democrats to push for the full $3.5 trillion bill despite heavy resistance form the more moderate Democrats.
President Biden continues to lobby Democrats to push for the full $3.5 trillion bill despite heavy resistance from more moderate Democrats. 

These yearly SALT deduction gimmicks mean that homeowners and homebuyers will have little clarity on their future taxes. The policy instability is a recipe for taxpayer chaos.

Putting it all together, these fake expiration dates could set the stage for $2 trillion in policy renewals that are not included in the original cost of the reconciliation bill. So $2 trillion becomes $4 trillion, and then combines with the March stimulus law ($1.9 trillion), infrastructure bill ($550 billion), and 10-year cost of higher discretionary spending ($1 trillion) for a total of $7.5 trillion in legislation enacted in one year. And that is on top of a $12 trillion baseline deficit over the decade in this historic borrowing binge.

Biden and congressional allies absurdly claim that this legislation would cost “nothing.” But there is no such thing as a free lunch, and the trillions in accompanying taxes are the opposite of free. 

Democrats have said that they are close to fixing the bill to include Sen. Kyrsten Sinema and Sen. Joe Manchin's demands.
Democrats have said they are close to fixing the bill to include Sens. Kyrsten Sinema and Joe Manchin’s demands. 

That said, progressives have thus far failed to build a consensus for even $1 trillion in new taxes. The latest proposal would assess annual taxes on billionaires’ theoretical investment gains that have not even been sold and received as income. While no one is going to cry for billionaires, no other country has adopted this policy because it is wholly unworkable. 

The IRS would have to determine the value of billionaire investments each year (Democrats claim it will affect about 700 people), including those of privately held companies and art that are rarely priced in the market. Then, the flip side of assessing annual taxes on paper investment gains is that the IRS would be sending billionaires a refund check during the years when the market falls or their investment values drop. Recessions are hard enough on the federal budget deficit without having the IRS mail massive refund checks to billionaires. 

And the policy would likely finance only a small fraction of the reconciliation bill, in part because much of the revenue represents an acceleration of capital gains taxes that would have been paid eventually when the investment was sold. The main “new” revenues would come from taxing certain investments that today can be legally passed down at death to heirs tax-free, but that policy can be addressed without creating this new boondoggle.

Speaker of the House Nancy Pelosi announced there will be a voting deadline for the reconciliation bill on October 31. 2021.
House Speaker Nancy Pelosi announced there will be a voting deadline for the reconciliation bill on October 31, 2021.

Democrats claim they are close to finalizing the reconciliation bill under Sens. Manchin and Sinema’s demands that it be smaller and fully paid for. Instead, taxpayers should prepare for a gimmick-filled spending bonanza that adds substantial new debt, and contains new tax structures that even tax-loving Europe won’t touch.

Walmart Issues Warning to All Customers: Product Tainted with Exotic Bacteria, Immediately Double-Bag It

A rare bacteria discovered in a specific Walmart brand product is being investigated by the Centers for Disease Control and Prevention following two deaths.

Roughly 3,900 bottles of six scents of the company’s Better Homes & Gardens Gem Room Spray are being recalled.

According to WJXT-TV, the following product numbers and scents may contain a bacteria known as Burkholderia pseudomallei:

  • 84140411420 Better Homes and Gardens (BHG) Gem Room Spray Lavender & Chamomile
  • 84140411421 Better Homes and Gardens (BHG) Gem Room Spray Lemon and Mandarin
  • 84140411422 Better Homes and Gardens (BHG) Gem Room Spray Lavender
  • 84140411423 Better Homes and Gardens (BHG) Gem Room Spray Peppermint
  • 84140411424 Better Homes and Gardens (BHG) Gem Room Spray Lime & Eucalyptus
  • 84140411425 Better Homes and Gardens (BHG) Gem Room Spray Sandalwood and Vanilla

“CDC has been testing blood samples from the patients, as well as soil, water, and consumer products from in and around the four patients’ homes since the agency began receiving samples in May,” a news release from the CDC said.

The agency pointed out that the spray was manufactured in India, which is consistent with the bacteria’s South Asian origins.

“A sample of the Better Homes & Gardens spray tested positive this week. The genetic fingerprint of the bacteria that sickened the four patients is similar to that of strains usually found in South Asia; the aromatherapy spray was made in India. CDC is coordinating with state health departments in Kansas, Minnesota, and Texas to try to determine whether the other three patients may have also used this or similar products.”

Burkholderia pseudomallei causes melioidosis, which typically shows up in humans as a lung or bloodstream infection, according to Healthline.

Four cases of the disease are being investigated for ties to the essential oil sprays, including the aforementioned two deaths.

For consumers who do own the product, there is a series of steps they are advised to take to safely remove the spray and its traces, according to the CDC.

Consumers are urged not to throw away the product, as the hazardous bacteria would still be a threat.

Instead, they should double-bag the product with two clear resealable bags, place the bagged spray into a cardboard box and return it to a Walmart location.

When handling the product, it is strongly recommended that gloves be worn to avoid contamination.

Other cleaning measures include washing sheets and towels the oil was sprayed on with hot water and drying them fully, and disinfecting any other surfaces that the spray may have been used on.

Those who do return the essential oil spray will receive a $20 Walmart gift card as a refund, and are advised to monitor themselves for symptoms if they ever used the product.

“Our hearts go out to the families that have been impacted by this situation,” Dr. Inger Damon, the CDC’s director of the Division of High-Consequence Pathogens and Pathology, said.

“We at CDC have been very concerned to see these serious related illness spread across time and geography. That is why our scientists have continued to work tirelessly to try to find the potential source for the melioidosis infections in these patients. We hope this work can help protect other people who may have used this spray.”

This incident should serve as a reminder to major companies that more of their goods should be made in the United States in hopes to avoid health crises like this one, as American-made goods are typically subject to tighter regulations.

Racine, Wisconsin County Sheriff’s Office to Announce PROOF OF STATE-WIDE ELECTION LAW VIOLATIONS – Thursday at 11 AM …UPDATE: THEY HAVE VIDEO!

The Racine Sheriff’s Office will hold a hearing on Thursday at 11 AM at the Sheriff’s substation.

Sheriff Christopher Schmaling will unveil the results of an extensive investigation with implications throughout Racine County and Wisconsin.

At the conclusion of the presentation, Sheriff Schmaling and the lead investigator will be available to answer questions and provide documentation.

The Racine Sheriff’s Office made the announcement Wednesday on their Facebook page.

— Gateway Pundit friend and news source Jefferson Davis will be at the briefing tomorrow.

UPDATE– From our source on the ground in Wisconsin. Sheriff Schamaling HAS VIDEO — Shows criminal actions by (Democrat) operatives! This will be lit!

Not Only Did Fauci’s NIAID Harm Dogs – Foster Children Also Died During AIDS Drug Research

Numerous children died as researchers sought HIV-infected foster kids on which to test dangerous drugs known to be toxic and deadly.

The National Institutes of Health conducted AIDS studies in the 80s and 90s which left some foster children clinical volunteers dead.

News of the decades-old studies, in which researchers sought HIV-infected foster kids on which to test dangerous new drugs, resurfaces as the nation reels from horrific experiments conducted on beagles by Dr. Anthony Fauci’s National Institutes of Health.

In order to recruit the foster children, NIAID ensured “independent advocates” would be on hand to safeguard children’s safety, however this was almost always never the case.

The sometimes-lethal experiments were covered in an Associated Press article by former reporter John Solomon, who documented how the government went about seeking “mostly poor or minority children” to be exposed to “medical research and drugs that were known to have serious side effects in adults and for which the safety for children was unknown.”

The research was conducted in at least seven states – Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas – and involved more than four dozen different studies. The foster children ranged from infants to late teens, according to interviews and government records.
 
Several studies that enlisted foster children reported that patients suffered side effects such as rashes, vomiting and sharp drops in infection-fighting blood cells, and one reported a “disturbing” higher death rate among children who took higher doses of a drug, records show.

Solomon explained government researchers in 1983 had agreed to have “child wards” monitor experiments and act as “independent advocates” on behalf of the children’s safety in studies “that involved greater than minimal risk and lacked the promise of direct benefit;” however, this policy was not enforced.

Some foster agencies, including those in Illinois and New York, required researchers to sign a document agreeing to provide the protection regardless of risks and benefits.
 
However, researchers and foster agencies told AP that foster children in AIDS drug trials often weren’t given such advocates even though research institutions many times promised in writing to do so.

For instance, “Illinois officials believe none of their nearly 200 foster children in AIDS studies got independent monitors,” Solomon reported.

Likewise, “New York City could find records showing 142 – less than a third – of the 465 foster children in AIDS drug trials got such monitors even though city policy required them.”

Researchers at Chicago Children’s Memorial Hospital and Baltimore’s Johns Hopkins University also confirmed no child wards monitored their studies.

The lack of safety advocates had dire consequences for the children, especially since they were engaged in risky Phase I and Phase II clinical studies.

“Some foster children died during studies,” Solomon reported. However, just as with current vaccine deaths, “state or city agencies said they could find no records that any deaths were directly caused by experimental treatments.”

Illinois officials confirmed two or three foster children were approved to participate in a mid-1990s study of dapsone. Researchers hoped the drug would prevent a pneumonia that afflicts AIDS patients.
 
Researchers reported some children had to be taken off the drug because of “serious toxicity,” others developed rashes, and the rates of death and blood toxicity were significantly higher in children who took the medicine daily, rather than weekly.
 
At least 10 children died from a variety of causes, including four from blood poisoning, and researchers said they were unable to determine a safe, useful dosage. They said the deaths didn’t appear to be “directly attributable” to dapsonebut nonetheless were “disturbing.”
 
“An unexpected finding in our study was that overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained,” the researchers concluded.

At the time, University of Pennsylvania medical ethicist Arthur Caplan argued researchers should have allowed child wards and would have known the study dangers since “there was great uncertainty as to how children would react to AIDS medications that were often toxic for adults,” reported Solomon.

“It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates,” Caplan said. “It is inexcusable that they wouldn’t have an advocate for each one of those children.
 
“When you have the most vulnerable subjects imaginable – kids without parents – you really do have to come in with someone independent, who doesn’t have a dog in this fight,” he said.

In 2009, an investigation commissioned by New York City claimed to find “no evidence that any children died as a result of the trials or that the foster children were selected because of their race.”

As noted by National File‘s Tom Pappert, Fauci’s official bio on the NIAID website proudly lists advancements in AIDS research among other accolades.

“As Director of NIAID, Fauci oversees research to “prevent, diagnose, and treat infectious and immune-mediated diseases, including HIV/AIDS” according to the website,” Pappert writes. “In 1988, Fauci became the first Director of the Office of AIDS research.”

Add the children’s deaths to the list of gruesomely egregious horrors carried out by the federal government’s National Institutes of Allergies and Infectious Diseases under Fauci’s watch.

Archbishop Vigano Denounces The Coronavirus Vaccine: ‘There Is A Duty To Refuse It’

Vigano Condemns The Corruption of ‘The Globalist Elite’

Catholic Archbishop Carlo Maria Vigano denounces the Coronavirus vaccine and the agenda of “the globalist elite” in an amazing letter to American bishops and others published by LifeSiteNews.

Vigano, who has gained worldwide admiration for chastising Catholic Church leaders over issues including the abuse of children, makes it clear that he rejects the vaccine on safety and moral grounds. Vigano calls the vaccine “absolutely immoral” and says that “there is a duty to refuse it categorically.”

Vigano also strongly opposes the Joe Biden regime’s plan to vaccinate children as young as 5 years old.

“The Note on the morality of using some anti-Covid-19 vaccines was issued last year in the absence of complete data on both the nature of the gene serum and its components,” Vigano writes in his letter to the bishops and others, in which Vigano exposes the faulty “safety and effectiveness of the vaccines,” argues that “the experimental drugs are not vaccines in the proper sense,” and raises alarms about “side effects on pregnant mothers and nursing children.”

“In this case, the health authorities have decided to carry out experimentation on the entire world population, as an exception to the usual practice of the scientific community, international standards, and the laws of individual nations. This means that the entire population finds itself in the condition of being susceptible to suffering the adverse effects of the vaccine, at their own risk, when normally experimentation is done on a voluntary basis and carried out on a limited number of subjects, who are paid to undergo it,” Vigano writes. “…I think it is evident that there are medical treatments without adverse side-effects, even though they have been systematically boycotted by the Health Institutions – WHO, CDC, EMA – and by mainstream media.”

“Having established that the drugs sold as vaccines do not give any significant benefit and on the contrary may cause a very high percentage of deaths or grave pathologies even in subjects for whom Covid does not represent a threat, I do not think that we can conclude that there is any proportionality between the potential damages and the potential benefits. This means therefore that there is a grave moral obligation to refuse inoculation as a possible and proximate cause of permanent damages or death. In the absence of benefits, there is therefore no need to expose oneself to the risks of its administration, but on the contrary there is a duty to refuse it categorically,” Vigano writes.

“Revelations from Pfizer executives have recently been released showing that the mRNA gene serums contain aborted fetal material not only for the production of the original vaccine, but also for its replication and production on a vast scale…This makes the use of these drugs absolutely immoral, just as it is immoral and unacceptable to use drugs that use orphaned children for experimentation,” Vigano writes.

“With every passing day, thousands of people are dying or are being affected in their health by the illusion that the so-called vaccines guarantee a solution to the pandemic emergency. The Catholic Church has the duty before God and all of humanity to denounce this tremendous and horrible crime with the utmost firmness, giving clear directions and taking a stand against those who, in the name of a pseudo-science subservient to the interests of the pharmaceutical companies and the globalist elite, have only intentions of death. How Joe Biden, who also defines himself as “Catholic,” could impose vaccination on 28 million children aged 5 to 11, is absolutely inconceivable, if only for the fact that there is practically zero risk of them developing the SARS-CoV-2 disease. The Holy See and the Bishops’ Conferences have the duty to express a firm condemnation in this regard, and also in relation to the very serious side effects that can result for children who are inoculated with the experimental gene serum. It is equally imperative that there be an intervention by the US Bishops’ Conference aimed at promoting the religious exemption and immediately revoking the bans imposed in this regard by many Ordinaries on their priests. Similarly, all vaccination requirements for seminarians and candidates of religious communities must be revoked. Instead, clear directives should be given about the dangers connected to the administration of the vaccine and its grave moral implications,” Vigano writes.

NATIONAL FILE RECENTLY REPORTED: Father James Altman, the Catholic priest who took on the left-wing Democrat agenda and stood up to Dr. Fauci’s Coronavirus tyranny, described his fight to maintain his pastor position against a corrupt Church campaign to get him ousted from the pulpit. Altman revealed details from the behind-the-scenes plot against him at the Stand with Father Altman event in White Bear Lake, Minnesota. Altman works at St. James the Less Roman Catholic Church in La Crosse, Wisconsin, and now the leadership of his diocese wants to force him out. Altman also revealed that some Cardinals in Rome hate him. Father Altman told the U.S. bishops who are against him to “Bring it On.”

“I’m man enough. I can defend myself,” Father Altman said to his supporters in Minnesota, describing the biased effort to force him out. Altman said, “And the USCCB (United States Conference of Catholic Bishops) has their basic playbook about how bishops can get rid of these priests they don’t like and that’s what they do.” Altman called his opponents “Monsters in miters,” and predicted that he will not receive justice within the crooked system. Nevertheless, Altman expressed his faith in the Truth movement, saying, “Everybody’s going to know now…That day is over, bishops of the United States. Because now, we’re coming back.” Altman vowed and told Bishops of the United States who oppose him to “bring it on.”

SO WHAT EXACTLY IS FATHER ALTMAN UP AGAINST?: Father Altman told his flock in May that he had been asked to resign by Bishop William Patrick Callahan of the La Crosse Diocese, stating “They want my head now for speaking that truth. I, a lowly priest, apparently have created enemies among some of the hierarchies.” But Father Altman outright refused to resign, raised more than $600,000, and prompted the Diocese of La Crosse to vow to force him out. An activist group called Faithful America celebrated Altman’s persecution, boasting, “Altman’s dismissal follows more than 18,000 petition signatures and hundreds of phone calls to Bishop Callahan from Faithful America members.” Faithful America lamented, “On Palm Sunday, Fr. James Altman preached that COVID-19 health guidelines are ‘godless, Nazi-esque controls,’ telling parishioners, ‘God damns every single one of those godless moves.’ He also said Dr. Anthony Fauci’s support for masks ‘is damnable in the hottest fires of hell.’ On Easter, Altman packed in 300-500 parishioners, with at least 50 maskless people jammed in the first five pews — violating his own bishop’s mask and capacity protocols…”

Member of Congress & His Children Threatened With Death By Former CNN Employee

The man who was recently arrested for threatening the life of Congressman Matt Gaetz (R-FL) and his family turned out to be an Emmy-nominated cameraman who has worked for CNNABC and NBC.

Eugene Huelsman was apprehended in Los Angeles last week for leaving life-threatening phone messages on Gaetz’s phone a few days after the January 6th U.S. Capitol incident.

Huelsman, who worked on shows such as “Late Night With Conan O’Brien,” said, “Tell Matt Gaetz to watch his back, tell him to watch his children. I’m coming for him… I’m gonna f—ing kill him… I’m gonna put a bullet in you and I’m gonna put a bullet in one of your f—ing kids too. I hate you,” according to an indictment and audio recording.

Tucker Carlson touched on the story with Kevin Corke during his Tuesday broadcast.

Just last week, Rep. Gaetz spoke on the House floor to condemn the DOJ after they denied a Capitol Police recommendation to arrest a different man who traveled across the country in an attempt to kill him in Washington, D.C. 

This individual messaged Gaetz on Twitter saying, “Portland has ordered a hit on you, I accepted the contract have a good day.” 

After the message, the man traveled to D.C. and the Capitol Police tried to get him arrested but the DOJ declined the request.

Gaetz told 3WEAR-TV, “I’m glad that prosecutors in the Northern District of Florida take death threats against me and my family seriously. I wish that were an ethic across the DOJ enterprise.”

Huelsman was released from custody Friday by an LA judge who set his bond at $20,000.

‘Equality begins in the womb’: March for Life unveils theme for 2022 DC event

The March for Life, the large annual gathering of pro-life activists in the nation’s capital, revealed that the theme for its 49th march next year is “equality begins in the womb.” 

Jeanne Mancini, president of the March for Life Education and Defense Fund, unveiled the theme on Wednesday at an event held at The Heritage Foundation headquarters in Washington, D.C., and live-streamed on Facebook.

During her remarks, Mancini explained that the theme came in response to the recent national dialogues about the nature of equality in the United States, saying the word is “invoked often,” yet “rarely defined.”

“While nearly everyone seems to agree that the topic of equality is important, there’s little agreement on what the definition of equality is, and who it applies to, and how that should be applied to important policy questions,” said Mancini.

“We want to expand this debate, this rigorous debate, about equality to include unborn children who are often overlooked because they cannot speak for themselves.”

Mancini said she believes “there is real value in our culture recognizing the inherent dignity of every human life” and that aspects like race, disability status, and economic background “don’t matter.”

“What matters is the fact that each of us is a human being,” she continued. “What matters is that life is precious, and that because it has this inherent human dignity, that it should be protected from the moment of conception.”

In addition to Mancini, pro-life activists including Carrie Campbell Severino of the Judicial Network, Ryan Bomberger of The Radiance Foundation, and Dr. Grazie Pozo Christie of The Catholic Association gave remarks at the unveiling event.

Heritage Foundation President Kay Cole James, who is scheduled to step down as head of the prominent conservative organization in a few weeks, gave the opening speech and spoke about how much she prioritizes the pro-life cause.

“The life issue is one that I care so deeply about,” said James. “At my heart, at the very heart, is fighting for the right to life of preborn children in our country, for the elderly, for those who are born with disabilities.”

It was also announced that at the pre-March rally, award-winning contemporary Christian music star Matthew West will perform for those who gather at the National Mall.

“I want to encourage you to join me and thousands of other pro-lifers who believe that every life matters, every story deserves a chance to be told,” said West in a video shown at the event. “It’s important for us to come together and be a voice for the voiceless.”

In January, for the first time in its history, the March for Life was held virtually due to the COVID-19 pandemic. The 2020 March for Life took place before the first lockdowns.

Speakers included various state lawmakers and former NFL quarterback Tim Tebow who talked about his mother’s decision not to abort him despite major pregnancy complications.

“I’m so grateful my mom gave me a chance at life, because many times she could have made the choice to do something different,” said Tebow to his virtual audience at the time. “But because of her pro-life story, I get to share my story.”

The 2022 March for Life, slated to take place Jan. 21, 2022, comes as the U.S. Supreme Court considers multiple cases that might overrule the 1973 decision Roe v. Wade.

Last week, for example, the Supreme Court agreed to hear oral arguments on Nov. 1 regarding the constitutionality of a Texas law that prohibits most abortions once a baby’s heartbeat is detected, which is usually around six weeks into a pregnancy.

Texas’ heartbeat abortion ban contradicts the legal precedent of Roe, which prohibits states from banning abortions before fetal viability.

FDA Panel Endorses Pfizer Shots for 5- to 11-Year-Olds, Experts Say Vaccine for Kids Is ‘Unnecessary, Premature and Will Do More Harm Than Good’

The U.S. Food and Drug Administration’s advisory panel today voted to recommend the agency allow Pfizer to amend its Emergency Use Authorization for its COVID vaccine for children 5 through 11 years old, despite a host of objections from scientists and physicians.

The U.S. Food and Drug Administration’s (FDA) advisory committee today endorsed Pfizer’s COVID vaccine for children ages 5 to 11, despite strong objections raised during the meeting by multiple scientists and physicians.

The vote passed with 17 supporting it and one abstention.

Before the shots can be rolled out, the FDA will have to formally authorize the vaccine, and the Centers for Disease Control and Prevention (CDC) must also weigh in with its own recommendations — but the Biden administration’s announcement last week that it has already ordered 68 million doses of the pediatric vaccine suggests Pfizer’s request will sail through.

During today’s meeting, the Vaccines and Related Biological Products Committee (VRBPAC) heard evidence from Pfizer and regulators, and listened to concerns from numerous experts.

According to the FDA website, as of Oct. 25, the agency had received 139,470 comments from the public prior to today’s meeting — a number federal officials described as strikingly high.

As he opened the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said, “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization.

Marks stressed the only question before the experts was whether shots should be allowed, not whether to mandate them, the New York Times reported.

The dose for younger children would be one-third the strength given to people 12 and older, with two shots given three weeks apart.

Based on CDC data presented during the meeting, among children 5 to <12 years of age, there have been approximately 1.8 million confirmed and reported COVID cases since the beginning of the pandemic, and only 143 COVID-related deaths in the U.S. through Oct. 14.

In this same age group, there were 8,622 COVID-related hospitalizations through Sept 18.

“This translates to cumulative incidence rates of approximately 6,000 and 30 per 100,000 for confirmed COVID cases and COVID-related hospitalizations, respectively, among children 5 to <12 years of age,” Pfizer’s application said.

Children with underlying medical conditions, such as asthma, diabetes and obesity, made up two-thirds of severe COVID cases.

Pfizer provided safety data on two study cohorts of children ages 5 to 11, both of roughly equal size. The first group was followed only for about two months, the second for only two-and-a-half weeks.

The two-month cohort included 2,268 children ages 5 to 11. Of the 2,268 children, 1,518 received the vaccine and 750 received a placebo. Each received two shots spaced three weeks apart.

Pfizer’s study found its vaccine was about 91% effective against symptomatic COVID in children, based on 16 cases of COVID in the placebo group and three cases in the vaccinated group over the brief follow-up period.

Most side effects occurred within a couple of days and included pain at the injection site, fatigue, headache, muscle pains and chills, Pfizer said.

According to Pfizer, the number of participants in the current clinical development program was “too small to detect any potential risks of myocarditis associated with vaccination.”

Long-term safety of Pfizer’s COVID-19 vaccine “to evaluate long-term sequelae of post-vaccination myocarditis/pericarditis” in participants 5 to <12 years of age will not be studied until after the vaccine is authorized for children,” Pfizer’s application noted.

Pfizer data insufficient, kids’ risk of vaccine injury greater than COVID risk, experts say

Experts raised concerns over the lack of safety and efficacy data presented by Pfizer for use of its COVID vaccine in younger children, and they pointed to increasing safety signals based on reports to the Vaccine Adverse Event Reporting System (VAERS).

They also questioned the need to vaccinate children — whose risk of dying from COVID is “almost nil” — at all.

According to Dr. Meryl Nass, member of the Children’s Health Defense Scientific Advisory Panel, Pfizer once again did not use all of the children who participated in the trial in their safety study.

“Three thousand children received Pfizer’s COVID vaccine, but only 750 children were selectively included in the company’s safety analysis,” Nass said. “Studies in the 5-11 age group are essentially the same as the 12-15 group — in other words, equally brief and unsatisfying, with inadequate safety data and efficacy data, with no strong support for why this type of immuno-bridging analysis is sufficient.”

Nass said, “All serious adverse events were considered unrelated to the vaccine.”

During the meeting and in its FDA application, Pfizer argued children should be vaccinated to prevent SARS-CoV-2 transmission, yet the company did not assess asymptomatic transmission.

Dr. Ofer Levy, a VRBPAC member, asked for evidence that Pfizer’s vaccine prevents transmission.

Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not assess whether the vaccine prevents transmission, but said there is evidence the vaccine prevents transmission in adults.

When questioned further, Gruber was unable to cite specific evidence to back his assertion.]

Steve Kirsch, founder of the COVID-19 Early Treatment Fund, asked the panel how they could do a risk-benefit analysis with Pfizer’s COVID vaccine if they did not know the CDC’s VAERS under-reporting factor (URF).

Kirsch asked:

“How can you do a risk-benefit of analysis of COVID vaccines if you don’t know the URF? This is extremely, extremely important. You have been assuming it has been one. It is not one. Using a URF of 41, which is calculated using CDC methodology, we find over 300,000 excess deaths in VAERS. If the vaccine didn’t kill these people, what did?”

“How many Americans have to die before you pull the plug?” Kirsch asked.

Kirsch also questioned the panel on why Maddie de Garay’s severe adverse reaction to the Pfizer vaccine, which left her paralyzed, was not reported by the company to the FDA.

Dr. Jessica Rose, viral immunologist and biologist, told the panel EUA of biological agents requires the existence of an emergency and the nonexistence of alternate treatment.

“There is no emergency and COVID-19 is exceedingly treatable,” Rose said.

In a peer-reviewed study co-authored by Rose, myocarditis rates were significantly higher in people 13 to 23 years old within eight weeks of the COVID vaccine rollout.

In 12- to15-year-olds, Rose said, reported cases of myocarditis were 19 times higher than background rates.

“In an act of censorship, this paper has been temporarily removed and it has now been killed without criticism of the work,” Rose said, noting the timing of the removal was strange.

Rose said tens of thousands of reports have been submitted to VAERS for children ages 0 to 18.

Rose explained:

“In this age group, 60 children have died — 23 of them were less than 2 years old. It is disturbing to note that “product administered to patient of inappropriate age was filed 5,510 times in this age group. Two children were inappropriately injected, presumably by a trained medical professional, and subsequently died.”

Dr. Josh Guetzkow, a senior lecturer at the Hebrew University of Jerusalem, said expanding the EUA to children is unnecessary, premature and will do more harm than good.

Guetzkow said there is no emergency for children, especially healthy ones whose risk of severe illness and death is “almost nil.”

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Guetzkow said kids with pre-existing conditions and prior COVID infections were not included in Pfizer’s study, so including them in the EUA is negligence.

“Pfizer’s trial is woefully underpowered to detect specific safety concerns, such as myocarditis, just like the adolescent study was, and if they weren’t able to detect an unexpected safety concern there, they wouldn’t be able to here,” Guetzkow said.

Guetzkow said:

“In Pfizer’s study, only .5% of controls were dropped due to important protocol violations, versus 3% in the treatment group. The odds of that happening by chance are 1 in 10,000. This deviation is poorly explained with no ITT analysis. The study is not double-blind and may be subject to bias. Most VSD safety monitoring programs have not reported results, why not wait?”

Guetzkow said, “from CDC reports, we can expect that for every 18 child hospitalizations prevented, at least 43 will end up in the hospital for all causes following vaccination,” yet, the “FDA’s risk-benefit analysis only counts myocarditis hospitalization.”

“Why ignore the V-safe data, and shouldn’t FDA verify Pfizer’s efficacy and immunobridging analysis first?” he asked.

Guetzkow said VAERS shows alarming safety signals, which cannot be attributed to increased vaccination, simulated reporting or COVID infections.’

“We calculated the ratio of adverse events reported per million Pfizer vaccinations to reports per million flu vaccinations among teenagers to see what to expect in children. Serious events are reported 51% more often for Pfizer, deaths 47 times, life-threatening conditions 49 times,” Guetzkow said.

Guetzkow asked the panel to look at the data on COVID vaccines compared to flu vaccines. Pointing to the data on reproductive organs, Guetzkow asked, “why would we expect children to take these risks to protect adults?”

There are more than 900 types of adverse events reported after Pfizer vaccination that have never been reported after flu vaccines, including 11 cases of multisystem-inflammatory syndrome (MS-C) that occurred without previous history of COVID infection, Guetzkow said.

He added that if the panel was considering authorizing Pfizer’s COVID vaccine to prevent MS-C — as Pfizer’s application suggested as one of the reasons they should —  the panel should reconsider.

During another part of the meeting, Julia Barnes-Weise, director of the Global Healthcare Innovation Alliance Accelerator, said pharmaceutical companies have concerns.

“One of them is, especially for a not-yet-approved vaccine, that they could be held liable for any injury that that vaccine seems to have caused,” Barnes-Weise said.

In a preliminary analysis last week, FDA reviewers said protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic, PBS News Hour reported.

Children’s Health Defense (CHD) said yesterday it would take legal action against the FDA if it granted EUA for the Pfizer-BioNTech vaccine for children 5- to 11- years old.

In a letter signed by Robert F. Kennedy, Jr., CHD chairman and chief legal counsel, and Nass, Kennedy and Nass wrote:

“CHD will seek to hold you accountable for recklessly endangering this population with a product that has little efficacy but which may put them, without warning, at risk of many adverse health consequences, including heart damage, stroke, and other thrombotic events and reproductive harms.”

Gas prices have risen $1.22 per gallon in just one year – costing drivers an extra $20 per fill-up – with rates at their highest since 2014, AAA says

  • US average gas price hit $3.38 per gallon on Monday, up 57% from last year
  • The pump price has gone up every day in the past 27 days, according to AAA
  • Global production is below pre-pandemic levels even as demand soars
  • White House says there is little Biden can do to bring relief for drivers 

Gas prices continue to rise, and are now at their highest level in seven years, according to the AAA Gas Price Index.

The national average price for a gallon of regular gasoline rose six cents over the past week to hit $3.38 on Monday, up $1.22 from a year ago, or an increase of 57 percent. 

With an average tank size of 18.5 gallons, it now costs drivers an extra $22 every time they fill up – and even more in states where gas prices are higher than the national average. 

The national average price for a gallon of regular gasoline rose six cents over the past week to hit $3.38 on Tuesday, up $1.22 from a year ago
Gas prices are displayed at a gas station in New York on October 13. Gas prices continue to rise, and are now at their highest level in seven years

‘With the U.S. economy slowly recovering from the depths of the pandemic, demand for gas is robust, but the supply is tight,’ said AAA spokesperson Andrew Gross in a statement. ‘We haven’t seen prices this high since September of 2014.’ 

Global oil production is still below pre-pandemic levels, and soaring demand has placed a crunch on supplies, raising prices for drivers. 

US crude oil production has still not recovered to pre-pandemic levels, and OPEC producers are withholding production to keep oil prices high. 

According to new data from the Energy Information Administration (EIA), total domestic gasoline stocks decreased by 5.4 million barrels to 217.7 million barrels last week. 

However, gasoline demand increased from 9.19 million barrels per day to 9.63 million.  

A man fuels a car at a gas station in New York this month. Global oil production is still below pre-pandemic levels, and soaring demand has placed a crunch on supplies

Since the cost of oil accounts for more than half of the pump price, consumers will be paying more as long as crude prices remain high, according to AAA. 

Because 70 percent of all retail goods in the US are shipped by truck, rising gas prices have the potential to spur broader price increases as well.

The Biden administration has faced harsh criticism over rising gas prices, but has ‘no immediate plans’ to tap into emergency reserves or limit energy exports outside the United States, the Energy Department told CNBC this week. 

Those two moves are among the limited options the administration has to make a quick impact on prices at the pump. 

‘There are limitations to what any president can do, as it relates to gas prices,’ White House press secretary Jen Psaki told reporters Friday. 

A customer stands behind her car as she pumps gas into it at a Valero station on October 12, in San Francisco, California. The San Francisco Bay Area has the highest gas prices in the US

Last week, one California town saw gas prices approach an eye-watering $8 per gallon. 

Residents of Gorda, a small community situated on the central coast, on Thursday saw the price of a gallon of gas hit an alarming $7.59 – $4 more than the national average.

Premium gasoline had reached an equally astounding $8.50 per gallon.

The Golden State tops the list of the most expensive fuel in the country: The national average is $3.36 compared with California’s $4.53 per gallon.