Feds Pay Zero Claims For COVID-19 Vaccine Injuries/Deaths

 By Adam Andrzejewski, CEO/Founder of OpenTheBooks.com. Mission: “Every Dime, Online, In Real Time.” First published in Forbes,

In fiscal year 2021, the U.S. government paid $246.9 million in claims for vaccine-related injuries and deaths. Not a single payout was related to Covid-19 vaccines.

Each person with a “provable” injury from a Covid vaccine could claim up to $379,000 from a special Covid vaccine fund set up by the federal government. The payout for death could be as high as $370,376.

However, according to an OpenTheBooks.com investigation, the federal government didn’t pay a penny for Covid-vaccine claims.

The special fund for these claims is called the Countermeasures Injury Compensation Program (CICP).

There were only 1,357 claims filed that alleged “injuries/deaths from the Covid vaccines,” and 53 were listed as deaths, according to recent reporting by the U.S. Department of Health and Human Services (HHS). By contrast, the self-reporting Vaccine Adverse Reporting System (VAERS) lists 16,310 deaths related to Covid vaccines. Of these, “5,326 of the deaths occurred on Day 0, 1,or 2 following vaccination[.]”

The low number of applicants to the CICP fund for injuries or death from the Covid vaccine suggests that people don’t know the special fund exists.

The “normal” vaccine fund, the National Vaccine Injury Compensation Program (VICP), has existed since 1988 and provides compensation for injuries or deaths associated with most vaccines routinely administered in the United States (such as pediatric and seasonal influenza vaccines), according to the Congressional Research Service.

Last year, this fund paid out $246.9 million in vaccine-related injuries and deaths. Payouts include $250,000 for a vaccine-caused death and $250,000 “for pain and suffering and emotional distress.” A special vaccine court handles these claims.

However, in the case of Covid-19 vaccines developed and approved under Project Warp Speed, deaths resulting from a Covid vaccine would pay out through the CICP and would pay more money than a vaccine-related death in normal times.

Since the benefit for a death caused by a Covid-19 vaccine is $370,376 for fiscal year 2021 and $50,000 per year for lost employment income (with a lifetime cap to be “generally $379,000”). So, the death benefit is $120,376 higher than for other vaccines ($250,000).

However, there is no equivalent to the VICP’s $250,000 “for pain and suffering and emotional distress” under the current Covid-19 parameters.

Here are some other differences between the two vaccine-injury funds:

1. No attorney fees. The Covid fund is not authorized to provide reimbursement for attorneys’ fees. Therefore, lawyers have less incentive to represent claims.

2. Injured children receive small payouts. A Covid vaccine-injured child would only be reimbursed for “reasonable medical expenses.” Since the child survived and isn’t employed, there’s no other compensation.

3. Narrow window to file a claim. The Covid fund allows a one-year window to file a claim whereas the regular vaccine fund has a three-year window.

And sure enough, the CICP fund hasn’t paid out a dime in Covid-vaccine claims. HHS bluntly states online, “As of October 1, 2021, the CICP has not compensated any Covid-19 countermeasures claims.” 

BACKGROUND:

The federal government is still operating under the “public health emergency” declared by Trump administration HHS Secretary Alex Azar on February 4, 2020. This declaration created a different funding stream for claims from adverse reactions to vaccines.

Congress established the Countermeasures Injury Compensation Program (CICP) as part of the PREP Act in 2005 to encourage the rapid development and deployment of medical countermeasures during a public health emergency. 

The Public Health Emergency (PHE) declaration has been renewed multiple times, most recently by Biden Administration HHS Secretary Xavier Becerra, on October 15, 2021, effective October 18, 2021. (Under federal law, the declaration lasts 90 days and can be renewed).

For the most part, since that February 4, 2020, declaration, “manufacturers, distributors, and health care providers are generally immune from legal liability (i.e., they cannot be sued for money damages in court) for losses related to the administration or use of covered countermeasures against Covid-19[,]” CRS reports.

This liability protection enabled those industry players to shift into high gear to address the pandemic without fear of lawsuits. Under the PHE declaration, the CICP funds any lawsuits related to adverse reactions proven by victims or their families

$246.9 million in non-COVID-vaccine-related claims (FY2021)

According to the VICP’s latest report dated October 2021, $4.6 billion in total compensation has been “paid over the life of the program” (which began in 1988). From 2006-2019, 6,054 claims were compensated out of the 8,516 petitions for compensation that were “adjudicated by the Court[.]”

According to the table included on page nine of the report, in fiscal year 2021 the U.S. government paid out $210.4 million to 722 petitioners, and, after adding in attorney’s fees the total U.S. taxpayer outlay was $246.9 million.

With such a complicated and bureaucratic process in place, it’s no wonder that zero Covid-vaccine claims have been paid to victims or their families.

NOTE:

The vaccine injury/death compensation issue was first tipped to us by the prestigious Illinois watchdog organization, Edgar County Watchdogs. Learn more here.

We reached out to Health and Human Services and a spokesperson replied. Review the entire response here.

“The Countermeasures Injury Compensation Program (CICP) is working to process claims as expeditiously as possible. For the majority of COVID-19 countermeasure claims, including COVID-19 vaccine claims, the CICP is still waiting for records and documentation to be submitted. About 90 percent of claims are awaiting medical records for review. Requesters are permitted to submit the necessary medical records after the claim is filed and this is the most significant factor in the processing time for CICP claims.”

*  *  *

Additional Information

• HHS Request For Benefits Form, Covid Vaccine Injury/Death Fund, here.

• “Countermeasures Injury Compensation Program (CICP) Data, Aggregate Data as of October 1, 2021, HHS Health Resources & Services Administration.

• Compensation Programs for Potential Covid-19 Vaccine Injuries Updated October 20, 2021, Congressional Research Service.

• “Covid-19 Vaccine Safety in Adolescents Aged 12–17 Years — United States, December 14, 2020–July 16, 2021,” CDC Morbidity and Mortality Weekly Report Weekly, posted online July 30, 2021, dated August 6, 2021.

• National Vaccine Injury Compensation Program Data Report,- updated October 1, 2021, Updated monthly, and includes the number of petitions filed; adjudications compensated and dismissed; awards paid by type and amount; claims by vaccine; and adjudication categories by vaccine.

https://www.zerohedge.com/markets/people-dont-know-special-fund-exists-feds-pay-zero-claims-covid-19-vaccine-injuriesdeaths

Dem plan to model child care after Obamacare is a disaster in the making

 Napoleon said, “Never interrupt your enemy when he is making a mistake,” but I cannot resist. 

Progressives in Congress are planning to pass a massive childcare subsidy regime as part of the “Build Back Better” human infrastructure package, but sadly this subsidy regime is a cut-and-paste of another poorly designed program: Obamacare. 

This will be a mistake because, as Obamacare did for health insurance, it will ultimately raise the cost of child care and hurt many American families. It will also create other unintended consequences for child care quality and availability.

How does the proposed childcare subsidy structure work? It’s central planning at its finest: Government planners have decided what portion of Americans’ income we should spend on childcare. After that limit, which is 7 percent for families making 150 percent of the federal poverty line or more, the government kicks in to pay for additional costs. 

Anyone familiar with the Obamacare health insurance exchanges knows the government established a maximum that subsidized customers can pay toward their premiums: 8.5 percent of their incomes. 

One almost has to wonder what’s next: Will the government step in to tell me what portion of my income I can dedicate to housing? Transportation? Food? The whole premise is silly; things cost what they cost. And government subsidies don’t change that.

Or do they? Government subsidies can actually raise the cost of whatever is being subsidized since they distort market signals by funneling more and more money toward health care, colleges and now perhaps child care. Subsidies do change who pays.

As Peter Nelson wrote recently of the Affordable Care Act subsidies, “With premium increases fully funded by government subsidies, issuers have little incentive to control premium growth.” 

But the demand-side subsidies for childcare aren’t the only way the government will increase costs. The childcare plan will increase wages for childcare workers up to what elementary school teachers earn. Regardless of what you think about this (whether it is merited or not), it will raise childcare costs. A lot. Just like Obamacare raised health insurance costs. A lot. 

Sadly, the childcare plan currently under consideration copies another of Obamacare’s design flaws, at least in its rollout: Many families will be ineligible for subsidies entirely before 2025. This means many families could face a $13,000 increase in childcare costs under this plan. 

This number is from an analysis by People’s Policy Project, a group that is critical of the childcare plan because it is not progressive enough in their view. To continue the health reform analogy, these would be like the people who want Medicare for All instead of Obamacare.

Bottom line: Instead of establishing a true universal government-run childcare system or going the other way and making the private childcare market more competitive and affordable, the proposal currently before Congress layers complicated government subsidies and requirements onto the existing system. This will drastically increase the cost of childcare but promises to dole out some sliding-scale subsidies to some people, sometime in the future. Sound familiar? 

And just as culture wars followed Obamacare (about birth control coverage, for example), culture wars will follow this childcare proposal, right into the classrooms where the youngest Americans are supposed to be learning their numbers and colors.

This is because when government funding gets involved, government rules and requirements get involved. It’s nonsense to think that 330 million Americans would all agree on what should be covered by a health insurance policy. Similarly, it’s nonsense to think we want the same type of childcare for our kids. 

Today, many Americans have resigned to living with Obamacare and whatever costs have come along with it. This may be because they do not see some of the behind-the-scenes problems faced by Americans in the market for individual (rather than job-based) insurance in the exchanges. 

Insurers, in response to Obamacare’s restrictions on how to price premiums, created plans with higher cost-sharing and narrower networks. What good will it do parents to have lower out-of-pocket childcare costs if there are no daycares open within 50 miles? Or if those daycares have 24-month waitlists to get a child into a classroom? Market realities have a way of surfacing, if not through higher prices to consumers, in other nasty ways, like implicit rationing. 

And once the government gets involved in subsidizing something, it’s never enough. Even now, as part of the Build Back Better plan, lawmakers are looking to make pandemic-induced “enhanced” Obamacare subsidies permanent. Just as Obamacare was a messy step toward single-payer health care, we can expect today’s childcare proposal to follow a similar path.

We shouldn’t go down this path. Obamacare had its merits, but surely Americans recognize that the promise to lower health insurance premiums was broken and the opposite happened. The real mistake here would be trusting the same people with the childcare system now. 

Hadley Heath Manning is director of policy for Independent Women’s Forum (www.iwf.org).

https://thehill.com/opinion/education/580311-democrats-plan-to-model-child-care-after-obamacare-is-a-disaster-in-the

Talaris therapy ends need for immune drugs in transplant patients

 Two kidney transplant patients who received a stem cell therapy developed by Talaris Therapeutics were able to come off all immunosuppressant drugs within a year, without any evidence of graft rejection.

The first findings from Talaris’ phase 3 trial of the cell therapy – called FCR001 – suggest it may be possible to eliminate the need entirely for patients to take what may be dozens of tablets daily after organ transplants, according to the US biotech.

While still preliminary, the experience with the two patients back up Talaris’ hope that giving a one-shot dose of FCR001 the day after an organ transplant could stimulate immune tolerance in the recipient, and avoid the side effects of current drug treatments such as infections, heart disease, and some forms of cancer.

The company’s approach relies on administering haematopoietic stem cells from the individual who donated the organ, in order to generate what Talaris refers to as chimerism, with both donor and recipient cells present in the bone marrow. That allows the immune system to see the transplanted organ as self rather than foreign.

The first two recipients in Talaris’ FREEDOM-1 phase 3 trial had received FCR001 at least 12 months earlier, and showed stable kidney function, according to Talaris.

A larger group of five patients who were at least three  months from the cell therapy  maintained more than 50% chimerism in their T cells, which the biotech said was a sign of “long-term, immunosuppression-free tolerance to the donated kidney”  in its phase 2 trials.

The FREEDOM-1 results reported at the American Society of Nephrology (ASN) meeting this week were accompanied by updated results from Talaris phase 2 study, in which all 26 patients originally weaned off immunosuppressants have continued to remain off them without rejecting their donated kidney.

Some transplant patients treated with Talaris’ therapy in earlier trials have now been off all immunosuppression for more than 12 years without signs of kidney rejection.

Talaris intends to enrol 120 subjects into the phase 3 trial, which is scheduled to generate results in 2023.

Earlier this year, Talaris raised $150 million via a Nasdaq listing that will be used to take FCR001 through the phase 3 programme in organ transplantation and as a treatment for rare autoimmune disease scleroderma.

It also recently started a phase 2 trial of the cell therapy to see if it is able to induce immune tolerance to a transplanted kidney in patients who received the transplant from a living donor up to a year prior to administration of FCR001.

https://pharmaphorum.com/news/talaris-therapy-ends-need-for-immune-drugs-in-transplant-patients/

Remote workers will not have to report proof of vaccination under OSHA’s new mandate

 The Biden administration unveiled two vaccination rules on Thursday that will soon impact 100 million U.S. workers and their employers. 

The first rule, which goes into effect on January 4th, requires companies with 100 or more employees to ensure that their workers are fully vaccinated against Covid-19 or that they test negative for COVID-19 at least once a week. The second requires health care workers to be vaccinated by the same deadline with no option for testing. 

Importantly, the vaccine mandate does not apply to employees who “do not report to a workplace where other co-workers or customers are present, or who work exclusively from home," notes labor and employment lawyer Keith Wilkes, a partner and shareholder at law firm Hall Estill. 

That means that OSHA will not require fully remote employees at companies like Facebook, Twitter, Dropbox, Ford, and Slack, which have allowed some employees to work from home, to report proof of vaccination or take weekly COVID tests—so long as they stay away from the office. 

If an unvaccinated employee has been teleworking for two weeks or more but must report to their office, where other employees will be present, they will need show proof of a negative COVID test within the seven days prior to visiting. 

Employers have 60 days until they must comply with the rules, but a long list of legal and reporting preparations await them. 

Employers will have to establish a compliant written policy on vaccination, determine the vaccination status of each employee, obtain acceptable proof of vaccination, provide support for employees who still need vaccination, create and enforce mask policies for those who are unvaccinated, and make certain records available to the Occupational Safety and Health Administration, who is enforcing the rule for most office workers (the healthcare rule will be enforced by the Centers for Medicare & Medicaid Services). 

They will also be required to provide their employees with information about their policies, information about vaccination efficacy, safety and benefits, and about criminal penalties for knowingly providing false information, said Wilkes.

The government is relying on companies to do the majority of rule-enforcement. There are only a few thousand OSHA workers around the country, and they will mainly be responding to complaints of non-compliance. Employers who are found guilty of breaking the rules will pay up to $13,653 per serious violation and 10 times that for repeated violations. 

Twenty-one states have opted out of OSHA’s governance and instead have OSHA-approved enforcement agencies for workplace safety. Those states will have to enact vaccine-requirement rules that are at least as effective as the federal rule within the next 30 days.

https://fortune.com/2021/11/04/remote-workers-osha-vaccine-mandate/

Covaxin: WHO approves India Covid vaccine for emergency use

 The World Health Organization (WHO) has granted approval for emergency use to India's government-backed Covid-19 vaccine, Covaxin.

The vaccine was approved in India in January while the third phase of clinical trials was still under way, sparking some concern and criticism.

Bharat Biotech, which makes the vaccine, has since published data suggesting 78% efficacy.

The WHO said in a tweet it believed the benefits far outweighed the risks.

Some experts had pointed to a fast-track approval and incomplete data, but the firm's chairman, Dr Krishna Ella, said the vaccine was "200% safe".

The WHO's expert panel, which authorises emergency approvals, had asked for more data last month while examining the application Bharat Biotech had filed in July.

In its approval it said:

• The vaccine was recommended for use in two doses, with a dose interval of four weeks, in all age groups 18 and above
• Covaxin had 78% efficacy against Covid 19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements
• Available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine safety or efficacy in pregnancy

The approval will also be a relief to the tens of millions of Indians who have received the jab - India has administered more than 105 million Covaxin doses so far - and a fillip for Bharat Biotech.

Few countries have recognised Covaxin and India hopes the WHO approval will change that.

How that will play out on travel restrictions for vaccinated Indians remains unclear.

Covishield, the Indian-made version of Astrazeneca, remains the most popular jab, accounting for most of India's 810 million jabs. It has been approved by the WHO but the UK recognised the jab only after a refusal to do so sparked anger in India.

India has so far fully vaccinated more than 253 million people - about a quarter of its eligible population.

And some 653 million people - about 70% - have had at least one dose of a Covid vaccine so far.

https://www.bbc.com/news/world-asia-india-58800168

in past 24 hours, we surpassed 50% of humanity with at least 1 shot of COVID vaccine

 

Ashish K. Jha, MD, MPH

@ashishkjha

For those who don't want more good COVID news, please skip rest of this tweet Still here? OK Sometime in past 24 hours, we surpassed 50% of humanity with at least 1 shot of a COVID vaccine There are now more humans who've gotten a vaccine than humans who have not Progress!

9:02 AM · Nov 5, 2021

https://twitter.com/ashishkjha/status/1456607731943677958

FDA’s crackdown on unproven stem cell therapies isn’t working

 In 2019, the Food and Drug Administration won a major victory when a judge shut down a clinic in Florida claiming to treat everything from back problems to heart diseases with stem cells. The decision was additional juice for the FDA to regulate the growing industry, which sells risky, unproven stem cell procedures as cure-alls.

But despite the high-profile success in Florida, the problem has gotten worse. There are more than four times as many businesses in the United States advertising unproven stem cell therapies now than there were four years ago, according to an analysis published today in the journal Cell Stem Cell that used online searches and Google Maps to find clinics. That’s despite a common perception that there’s been an FDA crackdown on the clinics offering these procedures, says study author Leigh Turner, a professor of health, society and behavior at the University of California, Irvine. As Turner sees it, with nearly 1,500 businesses operating 2,754 stem cell treatment clinics in the US in March 2021, whatever warnings regulators have issued to try and rein in the industry aren’t working.

“It kind of raises the question, is there really meaningful regulatory oversight at all?” Turner says. “There is on the books, but in reality, does it exist?”

Stem cell therapy, a broad term covering any treatments that use specialized cells that can morph into any cell type, has some real, evidence-based applications. Stem cells are used to treat some blood cancers, for example. There are efforts to develop stem cell-based treatments for conditions like amyotrophic lateral sclerosis, and stem cells from patients in need of an organ transplant have been used to bioengineer one, lowering the risk of rejection.

But most of the other ways people try to use stem cells are unproven, experimental, and risky. Medical practitioners selling these treatments claim the cells, which are usually taken from patients’ own fat or from donated umbilical cords, can treat everything from joint pain to degenerative eye conditions. There isn’t evidence to back up those claims, and the supposed treatments aren’t FDA-approved.

And the products have a dubious safety record. People have gone blind after receiving unregulated stem cell treatments. Non-FDA-approved treatments have also been linked to kidney failure and bacterial infections. Unproven and potentially dangerous therapies have become so prevalent that in 2019, Google announced it would ban ads for them.

Many of the clinics promoting stem cell therapies argue that repurposing someone’s own cells does not qualify as a new drug product, meaning they don’t need FDA approval. But the FDA says the cells are processed and manipulated enough that they become a biological drug product that the agency has to oversee — an interpretation that was affirmed by the 2019 case in Florida. In addition to winning the case to shut down the Florida clinic, over the last few years, the agency has sent letters to dozens of businesses warning them that the stem cells they use need approval before they’re marketed. The Federal Trade Commission and states attorneys general have also sued clinics over deceptive advertisements for claiming they can treat diseases.

These high-profile actions haven’t stopped the clinics from proliferating. There were only 351 businesses selling unproven stem cell therapies in the US in 2016 when Turner first investigated the matter. Now, according to his updated analysis, there are around 700 claiming to treat orthopedic injuries alone. Nearly 100 businesses say they can use stem cells to treat erectile dysfunction, and 23 say they use stem cells for autism spectrum disorder — and that they administer them to children. Most clinics included in the analysis didn’t list prices, but of those that did, the average cost was $5,118.

Turner thinks the spike in businesses offering stem cell therapies might be because the practice became normalized over the past few years, even as federal agencies tried to crack down. In addition to stem cell clinics, the businesses advertising stem cell therapies included chiropractors’ offices, sports medicine clinics, and other medical or quasi-medical practices.

“There seems to be a kind of move that’s taking place where it’s not just a kind of a couple of rogue clinicians who are way over the edge,” he says. “It’s much more run-of-the-mill: podiatrists, chiropractors, and naturopaths have moved into this space.”

Stem cell treatments are profitable. The barriers to entry are low, and there’s a steady supply of people who are suffering from conditions that standard medicine doesn’t have good answers for. People with spinal cord injuries or chronic pain can be targets for businesses claiming they can cure these problems. And the rise in the number of businesses offering the treatments even in the face of FDA action shows that the odds of someone facing consequences are, on the whole, fairly low. It’s a risk many businesses appear willing to take. “I think some people see this as it’s an opportunity to make a lot of money,” Turner says.

That could continue as long as the regulatory landscape stays the same. Experts have been waiting for the other shoe to drop for years, Turner says. But instead, things have gone in the opposite direction.

An FDA spokesperson said in an email that the agency doesn’t comment on individual studies, “but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

It’s not clear whether the agency will respond more decisively in the next five years or if the market for these products will continue to spiral, Turner says. “I do find myself wondering — when you have a marketplace this large that isn’t well regulated, can you ever get it under control?”

https://www.theverge.com/2021/11/4/22761580/stem-cell-clinics-fda-oversight