Coronavirus Crisis: Main Thread

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https://www.cnbc.com/2021/10/15/heart-i ... -says.html

Risk of mRNA Covid booster causing heart inflammation in young adults continues to worry scientists, Dr. Ofer Levy says

KEY POINTS

Dr. Ofer Levy, a voting member of the FDA's vaccine advisory panel, spoke with CNBC's "Closing Bell" after the committee unanimously recommended the agency approve J&J's Covid boosters.

The panel previously recommended the FDA approve boosters from Moderna and Pfizer for anyone 65 and older, among other high-risk groups.

Some committee members have voiced concern about authorizing third mRNA doses for people 12 and up due to the risk of two rare heart inflammation conditions.

We're at a very delicate time in this pandemic: FDA advisory panel member

The risk of mRNA Covid booster shots causing heart inflammation in young adults continues to worry top scientists weighing whether to approve third doses for anyone over 12, Dr. Ofer Levy, a voting member of the Food and Drug Administration's advisory panel, said Friday.

Levy, the director of the Precision Vaccines Program at Boston Children's Hospital, spoke just hours after the FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommended giving second shots to all recipients of Johnson & Johnson's single-dose Covid vaccine over 18 years old.

The panel previously recommended the FDA approve boosters from Moderna and Pfizer for all seniors and other high-risk groups. But some committee members have voiced concern about authorizing third mRNA doses for people 12 and up due to the risk of two rare heart inflammation conditions, myocarditis and pericarditis.

"As we go into younger and younger age groups, they're less and less at personal risk of severe Covid, and on the other hand, somewhat more at risk of this inflammatory heart condition with the mRNA vaccine," Levy told CNBC's "Closing Bell." "So it's a risk benefit analysis, and that's why you're seeing that deliberation."

Though uncommon, myocarditis has been found mostly in male adolescents and young adults who received a vaccine from Pfizer or Moderna, according to the Centers for Disease Control and Prevention. Cases typically arise within days of vaccination, usually after the second dose, and subside with medicine and rest, the CDC said.

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https://twitter.com/R_H_Ebright/status/ ... 5508858880

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From 2019, Nostradamus speaks:

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https://www.reuters.com/legal/governmen ... 021-10-19/

COVID vaccine injury claims mount, but recourse is lacking for those harmed

(Reuters) - As the Biden administration puts the final touches on an emergency COVID-19 vaccine mandate for companies with 100 or more employees, a crucial piece seems to be missing for the unlucky few who experience serious side effects: meaningful legal recourse.

More than 1,300 COVID vaccine-related injury claims are now pending before an obscure government tribunal, which to date has decided only two such cases, one involving swelling of the tongue and throat following the jab, the other alleging long-lasting, severe shoulder pain.

In both instances, the government, which requires claimants to prove their injuries are “the direct result” of a COVID-19 vaccine, denied compensation.

It’s a steep burden of proof. Lawyers tell me the vaccine is so new that there’s virtually no definitive research on injury causation to cite.

Indeed, the overwhelming majority of all litigants under what's known as the Countermeasures Injury Compensation Program have not succeeded. According to program data, 29 claims have been paid for injuries stemming from other vaccines since the tribunal’s inception in 2010. (Ten additional claims won approval but no compensation.) The other 455 claims – 92% – were denied or otherwise deemed ineligible for review.

For those who prevailed, the median award was $5,677, according to my calculations, spanning from a low of $31 to a high of $2.3 million, for a person who contracted Guillain-Barre Syndrome after receiving the H1N1 influenza vaccine.

There is no provision for damages based on pain and suffering.

For people like Jessica McFadden, who said she developed life-threatening blood clots after receiving Johnson & Johnson’s COVID-19 vaccine in April, legal options are unclear. She's not optimistic about her odds of recovering her losses, and it's certain she won't be able to recover any pain and suffering damages under the Countermeasures Injury Compensation Program.

McFadden, 44, said she was previously healthy and needed two emergency surgeries to remove massive clots in her lungs, heart and left leg. She spent nine days in the hospital, racking up $489,153 in medical bills, she said. Her insurance will cover most, but not all of the tab, she said, and she estimates she'll pay up to $7,000 out of pocket.

She emailed me a photo of extracted clots, which she said were removed during an agonizing procedure performed while she was conscious. They are thick and ropy, like nightcrawlers on a surgical tray.

McFadden, who said she has returned to work but is still taking blood thinners, has not spoken publicly of her ordeal until now. “I’m not an anti-vaxxer. I understand the need for the vaccine,” she said. “I was just trying to do the right thing.”

To be clear, an experience like McFadden described is extremely rare. The Centers for Disease Control and Prevention in May said that out of 8.7 million people who had gotten the J&J jab, only 28 suffered the complication known as thrombosis with thrombocytopenia syndrome. Per the CDC, there is a "plausible causal association" between the vaccine and the blood clots.

Johnson & Johnson in a statement said, “The safety and well-being of the people who use our products is our number one priority.”

To McFadden, the issue is not that COVID-19 vaccines are bad or that no one should get them. Rather, she said, what’s important is how we care for people “when something catastrophic happens” as a result, especially now that vaccine mandates are becoming so widespread.

For decades, vaccine makers have been shielded from product liability lawsuits thanks to the National Childhood Vaccine Injury Act of 1986. The law was passed after pharmaceutical companies were hit with lawsuits over a brain injury known as pertussis vaccine encephalopathy and threatened to quit making the DPT (diphtheria, pertussis and tetanus) vaccine altogether.

Under the 1986 law, people who claim to have been injured by DPT, hepatitis, influenza and other common shots bring their cases in a special, no-fault tribunal, the Vaccine Injury Compensation Program, known colloquially as “vaccine court.” Payouts (including attorneys’ fees) are funded by a 75-cent tax per vaccine.

The forum is far from perfect, but over the years, it has awarded more than $4 billion to injured claimants.

But that’s not where the COVID-19 vaccine injury cases are being decided.

In March 2020, then-Health and Human Services secretary Alex Azar issued a declaration under the Public Readiness and Emergency Preparedness (PREP) Act of 2005 providing liability immunity for medical countermeasures related to the novel coronavirus. Injury claims would be handled by the Countermeasures Injury Compensation Program, which is run by the Health Resources and Services Administration and is geared toward public health emergencies.

Coverage for claimants is limited: Lost wages up to $50,000 a year and out-of-pocket medical expenses. If the person died, his or her next-of-kin can seek death benefits up to $370,376.

A spokeswoman for HRSA declined my request for an interview but explained in an email how the process works.

First, the person claiming an injury submits a request for a benefits form and relevant medical records. For COVID-19 vaccine injuries, the claims already include a veritable Merck Manual of maladies, everything from dizziness to deafness to death, according to HRSA data.

The form is “reviewed by CICP medical staff,” who decide whether the requester is eligible for program benefits.

If requesters don’t like the decision, they can ask for reconsideration by “a qualified panel, independent of the program.” The panel makes a recommendation to the associate administrator of the Health Systems Bureau of HRSA, whose decision on the payout is final.

You might notice a few things are missing, like an independent judge, a chance to present one's case in person, damages for pain and suffering and the right to appeal beyond the agency.

Vaccine court has all these features. CICP has none.

But this is where the COVID-19 vaccine cases are relegated, at least for now. Per the steps laid out in the 1986 vaccine law, for the COVID-19 vaccine to move to vaccine court, the CDC must first recommend the shots for routine administration to children. Then Congress must pass a law adding the 75-cent tax on each COVID-19 vaccine given, and the Secretary of Health and Human Services must move the vaccines to the Vaccine Injury Compensation Program.

All of this could take years.

Legislation is pending in Congress that would expedite the process (as well as upping vaccine court damages, extending the statute of limitations from three years to five and adding more special masters), but it has yet to gain traction.

Spokespeople for the bill’s sponsors in the House of Representatives – Texas Democrat Lloyd Doggett, and Republicans Fred Upton of Michigan and Mike Kelly of Pennsylvania – did not respond to requests for comment.

In the meantime, people like McFadden face a strict one-year deadline from the date of vaccination to file a claim with the CICP. But it’s not clear if filing in the CICP would preclude her from later moving her case to vaccine court, should that become an option.

She told me that she's waiting until early next year to decide how to proceed.

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https://www.texastribune.org/2021/10/19 ... ter-hotez/

It’s cheap, easy to make and in demand overseas. So why can’t this Texas-born COVID-19 vaccine break into the U.S. market?

A Houston vaccine team would like a U.S. distributor but for now focuses its efforts abroad to inoculate those in countries where COVID-19 variants surface more quickly.

The day before COVID-19 claimed its first Texas victim in 2020, Dr. Peter Hotez was a guest on the popular Austin-based podcast “The Drive.” After 10 years of research into coronavirus vaccines, Hotez and his Houston team needed an infusion of cash to build on their past work and make a vaccine that could, as Hotez told listeners then, “rescue the world” from the deadly emerging coronavirus pandemic.

“You’d think that people would be pretty eager to support us to move this forward, but so far it hasn’t happened,” the Houston pediatrician and vaccine scientist told the host, Dr. Peter Attia, on March 14, 2020.

By the following week, major cities in Texas began to shut down to avoid widespread community outbreaks.

But Hotez’s plea worked. The donations started coming in support of efforts in the deadly new pandemic at the Baylor College of Medicine at the Texas Children’s Hospital Center for Vaccine Development, co-directed by Hotez and Dr. Maria Elena Bottazzi in Houston — both of whom are celebrated pioneers in the area of vaccines for neglected tropical diseases like chagas and schistosomiasis.

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Now, nearly 18 months later, the Houston team’s vaccine, called Corbevax by its maker in India, is cheap, has no patent, can be made by many vaccine producers globally — including those in low- and middle-income countries — and is poised to receive approval for widespread global use.

The Indian government has promised the biopharmaceutical company Biological E Limited, which is making the vaccine in that country, that it will buy 300 million doses with the potential for more.

A halal version of the vaccine, for use in Islamic countries because it doesn’t contain animal-based ingredients, is also about to start clinical trials in Indonesia. And later this year, the company hopes the vaccine will be endorsed by the World Health Organization for use globally, which could open the doors to quicker authorization in several countries that need it.

But here in the United States, this “truly Texas vaccine,” as its creators like to call it, has no home.

A Texas-style vaccine

The fact that the vaccine even exists can be traced to a lot of Texas money, including funds from The Robert J. Kleberg, Jr. and Helen C. Kleberg Foundation and the M.D. Anderson Foundation. Several high-level and anonymous individual donors pitched in, as well as the JPB Foundation in New York.

Those donations funded a vaccine prototype with the initial doses mixed in the Houston lab and transferred to Biological E in India in May 2020. By November, BioE began clinical trials of the vaccine in India, where the delta variant was first identified and which has one of the lowest vaccination rates in the world. Total cost from creation to market was between $5 million and $7 million, Bottazzi said.

The U.S. government has yet to get on board. Operation Warp Speed, the public-private partnership created by the federal government to accelerate treatments and vaccines for COVID-19, spent none of its billions at the Houston lab.

Most experts, including Hotez and Bottazzi, agree that’s because most of the funding and the attention — and the bets — are on the vaccines made earliest in the pandemic, and with the newest technology, by Pfizer, Moderna and Johnson & Johnson and a few others.

“We’re pushing the new ways because they’re better and faster,” said Dr. Benjamin Neuman, a Texas A&M University virologist who has been doing coronavirus research since 1996, though he was not involved in any of the approved vaccines' development. “Why wouldn't you want to have it all?”

Competition from new tech

The mRNA vaccines by Pfizer and Moderna use messenger RNA, a molecule the virus needs to produce a “spike protein” and bind to human cells, to prompt the immune system to produce antibodies against that protein. Five years ago, Neuman said, that process hadn’t been made effective yet.

But by the time Hotez was making his plea on Attia’s podcast, Moderna was already starting up clinical trials of its mRNA vaccine in partnership with the National Institutes of Health, the biomedical research arm of the U.S. government and the largest center of its kind in the world.

And by late 2020, when BioE was rolling out its phase 1 clinical trials with Corbevax in India, Pfizer was already getting emergency use authorization from the U.S. Food and Drug Administration.

The Bottazi and Hotez vaccine relies on a production process very similar to the way the Hepatitis B vaccine is made that’s been produced and used around the world for decades. The two argue that the familiarity with the process and the ease with which the materials can be gotten makes it easier to quickly ramp up global production compared to the newer vaccines, even if they came onto the market a little later.

But aside from a handful of philanthropies who can see the value of the domino effect — more vaccinations outside this country help lower infections around the world and here — Hotez and Bottazzi have heard nothing about producing or distributing here at home.

“Why weren’t conventional vaccine technologies given the opportunity of being at the same table as all these other technologies?” Bottazzi said.

...

While the Houston team waits for a production and distribution partner, the team fields calls every week from other countries asking them for help getting access to the vaccine, Bottazzi said.

They ask if they can get the spare doses that Americans are declining or if they can get connected to BioE to export to them from their Indian-made stocks — or if the scientists will share the formula for the prototype.

The scientists share the formula with any country or lab who asks for it and help in other ways, however they can.

“We’re kind of practicing our own version of Texas vaccine diplomacy,” Hotez said.

Vaccination rates for developing countries are still in the single digits. About 38% of the world population is fully vaccinated against COVID-19. Many African countries, such as Sudan, Kenya and Ethiopia, have a rate below 2%. ...

Hotez and Bottazzi believe their vaccine would likely be more accepted by those who don’t trust a vaccine that is unfamiliar to them, like those by Pfizer and Moderna.

...

Even if it would make a difference, the path to emergency use authorization for a COVID-19 vaccine in this country starts with money — for research, for trials, for materials — and ends with firm commitments from the U.S. to support its mass production.

The Bottazzi-Hotez shot, at this point, has neither.

And so Hotez, who is an internationally known and outspoken warrior against the anti-vaccine movement, and Bottazzi redouble their attention abroad to protect Americans who can’t or won’t protect themselves. If they can get more of their vaccine overseas within a few months, they can keep the variants from percolating and landing on U.S. soil.

“It’s a pretty ambitious, audacious goal,” Hotez said. “But I think we could get there.”

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https://www.sciencedirect.com/science/a ... 0621002267

TEMPORARY REMOVAL: A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products

The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.

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Whoops! They almost let this one past the censors!

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Video presentation

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https://archive.md/NHPe6

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https://eugyppius.substack.com/p/maximu ... medium=web

Corona is primarily dangerous to the very old and the already sick. Occasionally, it is true, somebody who is younger or not already sick ends up dying. This happens with influenza and other viruses too. While that’s regrettable, Corona is not the leading cause of tragedies like these, and on balance they are too rare to pose an overarching unprecedented global threat to our hospitals, to our public health, to our nursing homes, or to whatever it is we’re supposed to be worried about right now. Given the stratified nature of Corona risk, the majority of the gains to be had from stimulating SARS-2 antibodies are concentrated in around 10-15% of the population. This is true whatever you believe about the vaccines, their safety or their efficacy.

If you want to lower hospitalisations and deaths, in other words, the difference between vaccinating 40% of your population and 80% of your population is not nearly as great as it seems. In fact, as you move to ever lower-risk cohorts, the volume of vaccinations required to reduce deaths grows in inverse proportion to the deaths you are reducing. This is the phenomenon of diminishing returns. It means that if you have vaccinated all the olds and sicks and an additional 50% or 70% of everyone, AND you are still suffering from a raging pandemic of the unvaccinated, there are probably not enough immunologically naive people left to give you a hope of vaccinating your way out.

The unspeakable truth is that the vaccines don’t suppress case rates at all. We have long known that their efficacy against infection fades to zero after week 20, but even at the high point — the first month after dose 2 — the protection is sure to be vastly overstated. This would be why even academic journals are starting to run pieces with titles like “Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States”:

At the country-level, there appears to be no discernible relationship between percentage of population fully vaccinated and new COVID-19 cases in the last 7 days… In fact, the trend line suggests a marginally positive association … Notably, Israel with over 60% of their population fully vaccinated had the highest COVID-19 cases per 1 million people in the last 7 days. The lack of a meaningful association between percentage population fully vaccinated and new COVID-19 cases is further exemplified, for instance, by comparison of Iceland and Portugal. Both countries have over 75% of their population fully vaccinated and have more COVID-19 cases per 1 million people than countries such as Vietnam and South Africa that have around 10% of their population fully vaccinated.

Here’s their scatter-plot:



Unsurprisingly, the authors find that the same is true of US county-level data as well:

Across … US counties … the median new COVID-19 cases … is largely similar across the categories of percent population fully vaccinated … Notably there is also substantial county variation in new COVID-19 cases within categories of percentage population fully vaccinated. There also appears to be no significant signaling of COVID-19 cases decreasing with higher percentages of population fully vaccinated…

So high rates of vaccination can’t reduce infections, and vaccinating the oldest and sickest hasn’t done very much for overall hospitalisations and deaths either. Yet our governments press on, not because the vaccines are working, but because they’re not. We’ve been through all of this before. Last year, large swathes of the developed world banned most of public life because everyone decided that this was the way to save lives. Wuhan convinced them that lockdowns work, in much the same way as the Pfizer/BioNTech trials convinced them that vaccines work. Except lockdowns didn’t work, and vaccines don’t really work either. Corona rages on, indifferent to the strange learned fantasies of our medical bureaucrats.

A consequence of these failures is raging cognitive dissonance among the elite, and a substitution of the means for the end. Last year, it was locking down itself that became the highest policy goal. Governments schemed less about how to get cases down, than about how to reduce the Google-certified mobility of their citizenry by margins great enough to satisfy their court astrologers. The same is now true of the vaccines, which in their failure to do much about anything, have become the focus of nearly all Corona policy everywhere in the world. All that our governments want to do now is vaccinate more and harder. They want to vaccinate all of the unvaccinated, and when that grows tiresome they will want to triple and quadruple vaccinate the already-vaccinated. And they especially want to vaccinate that last demographic that has so far remained largely exempt from vaccination, namely children.

This would be little more than a global comedy at the expense of our worthless public health establishments, if we did not have abundant evidence that the vaccines are more dangerous than is normal for vaccines; and if SARS-2 did not pose such an infinitesimal risk to children, as to make even totally safe, ordinary vaccines an unacceptable measure in this context.

A beloved argument for vaccinating kids despite allegedly rare disturbing side effects, like myocarditis, is that these are also rare complications of Corona infection. Indeed, we are told that Corona is more likely to cause myocarditis than the vaccines. The truth of course is that we don’t know the true rate of Corona-induced myocarditis in children, because most of infections go unnoticed. Beyond that, after the brief, 20-week window of protection against infection expires, vaccinated children will contract Corona at the same rate as unvaccinated children, and so the real question for Team Vaccine is simply this: Do the vaccines reduce the already near-zero longer-term myocarditis risk from Corona infection in children enough to compensate for the risk of myocarditis that they add?

This question is not likely to have an encouraging answer, but that will not stop mass child vaccination, to secure what will surely be the most diminished of all our diminishing returns so far. The only rationale necessary for vaccinating every last living organism is the same as the only rationale necessary for locking down all of human society: The disease statistics are not improving, and the only thing to do when they are not improving, is more of the thing that you sold to everyone beforehand, on basically no evidence, as the sole solution.

We have entered the world of Maximum Vaccination. Our best hope is that the farce of Corona suppression completes its self-discrediting arc before it can do much more damage.

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https://alexberenson.substack.com/p/pfi ... r/comments

Pfizer and BioNTech announce their vaccine is USELESS 11 months after dosing…

Well, that’s not how they phrased it.

But it is the only reasonable way to read their press release claiming that the booster is 95% effective.

Remember. The booster is given to people who have RECEIVED the vaccine. (That’s why it’s a booster, right?)

And when they tested a booster against a placebo in those people, they found a 95% reduction in disease in people who received the booster (for a total of 11 weeks after they received the booster, excluding the first week, because science - by which I mean because including that week would not help their results).

95%!

Where have you heard that figure before? Oh yeah, it is EXACTLY the same relative risk reduction they claimed in the pivotal trial last year, when they tested the INITIAL dose against placebo.

The only reasonable read is that the booster is providing (temporary) protection similar to the first two-dose series (temporarily) did AGAINST PLACEBO. But these are VACCINATED people.

So where’s the protection from the initial two doses?

There is ONE difference, though. The ABSOLUTE risk appeared at least two to three times higher in the vaccinated people in this trial than in UNVACCINATED people in the initial trial - 110 infections in 5,000 people in 10 weeks, compared to 162 infections in 20,000 people in about the same period.

Because vaccines work.

If you are vaccinated, get ready to take boosters forever.

By the way, the press release includes NO specific safety data.

Yay Pfizer!

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https://www.bbc.com/news/uk-scotland-58899460

Scotland's excess deaths at highest level since January

The National Records of Scotland said 1,353 deaths from all causes were registered in the week to 10 October.

This was 315 more than the average for the same week from 2015 to 2019, and the highest rate of "excess" deaths since the first week of January 2021. These included deaths linked to cancer, heart disease and dementia. This comes even as the number of deaths where Covid was mentioned in the registration fell for the second consecutive week, to 126.

The number of deaths linked to the pandemic had been rising since mid-August, but appears to have peaked in the week ending 27 September at 167 - far below previous peaks during the initial outbreak of the virus and at the start of 2021.

The figure fell to 143 the following week, and has now dropped by 17 to 126 - 100 of which were of people aged over 65, and 98 of which occurred in hospitals. Men accounted for 82 of the deaths, while 44 were women.

One further death was also registered which was linked to adverse affects from a Covid-19 vaccine.

That brings the total number of deaths where the vaccine was an underlying cause to five, against a population of 4.2 million in Scotland who have had at least one dose.

What were the causes of death?

The 315 excess deaths logged last week represents a 30% increase on the five-year pre-pandemic average for this time of year.

They include;

44 cancer deaths,
40 more deaths linked to circulatory conditions,
27 dementia or Alzheimer's deaths,
and seven from respiratory conditions.

This marks the 20th consecutive week with excess deaths above the five-year average, and highest since the week ending 10 January, 2021.

Of course, just one of these excess deaths was due to a massive vaccination campaign (using a new mRNA technology that has never been tested for mid or long term effects on humans but that cause huge spikes in mortality in previous animal trials). All the rest of these excess deaths remain a complete mystery. There is nothing we can imagine that could have possibly caused them!