We could soon have vaccines for cancer and HIV thanks to COVID-19 vaccine discovery: report

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We could soon have vaccines for cancer and HIV thanks to COVID-19 vaccine discovery: report

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We could soon have vaccines for cancer and HIV thanks to COVID-19 vaccine discovery: report

https://us.yahoo.com/news/could-soon-va ... 41415.html

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The COVID-19 vaccine uses first-of-its-kind mRNA technology to protect a person from infection.

Scientists are now applying that technology to other difficult-to-treat diseases like cancer and HIV.

Clinical trials are currently underway and have promising initial results.

Visit Insider's homepage for more stories.

Scientists are experimenting with COVID-19 vaccine technology as a way to treat terminal illnesses like cancer and HIV, Inverse reported.

That's because the coronavirus pandemic pushed scientists to create a first-of-its-kind vaccine using mRNA, or a small piece of a coronavirus particle's spike protein, to create an immune system response that protects from infection.

It's an approach vaccine researchers have been studying for the past 25 years, Insider previously reported.

Following effective clinical trial results and millions of successful vaccinations with mRNA-based COVID-19 vaccines, researchers now are looking into how the discovery could make way for other coveted treatments.

Scientists are gearing up to study mRNA for cancer and HIV treatment
Scientists at The University of Texas MD Anderson Cancer Center are preparing to study mRNA as a cancer treatment right now.

They believe mRNA could be used to prevent cancer recurrence, Dr. Van Morris, an oncologist heading the clinical trial, said in a recent article on the MD Anderson website.

The likelihood of cancer recurring varies based on the type of cancer, and is most common with ovarian cancer, bladder cancer, and glioblastoma. Recurrence happens when small amounts of cancer cells stay in the body after treatment, multiply, and in some cases move to other areas of the body.

In the trial, which is currently in its second phase, doctors test cancer patients who had tumors removed and went through chemotherapy. Once tests reveal cancer cells that are still circulating throughout their bodies, the researchers create individualized mRNA cocktails.

"We're hopeful that with the personalized vaccine, we're priming the immune system to go after the residual tumor cells, clear them out and cure the patient," said Morris.

Scientists at Scripps University in California are also looking at HIV, a sexually transmitted infection that affects 1.2 million people worldwide, as a candidate for an mRNA vaccine.

Similar to the way the COVID-19 vaccine attaches to spiky coronavirus proteins and kills them, the HIV vaccine could do the same with HIV particles, William Schief, an immunologist at Scripps Research who helped develop the HIV vaccine in a Phase 1 trial, said in a press release.

Now that Schief's team knows mRNA can be used to target and kill HIV, they'll use that technology in future studies in the hopes of soon creating an HIV vaccine.

Since the advent of the COVID-19 vaccine, researchers have also pivoted to diseases they anticipate will become greater threats in the coming years.

The Oxford University scientists who collaborated with AstraZeneca to develop their COVID-19 vaccine are now working on a vaccine to treat the sexually transmitted disease gonorrhea, Insider previously reported.
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Re: We could soon have vaccines for cancer and HIV thanks to COVID-19 vaccine discovery: report

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The story of mRNA: How a once-dismissed idea became a leading technology in the Covid vaccine race

https://www.statnews.com/2020/11/10/the ... cine-race/

ANDOVER, Mass. — The liquid that many hope could help end the Covid-19 pandemic is stored in a nondescript metal tank in a manufacturing complex owned by Pfizer, one of the world’s biggest drug companies. There is nothing remarkable about the container, which could fit in a walk-in closet, except that its contents could end up in the world’s first authorized Covid-19 vaccine.

Pfizer, a 171-year-old Fortune 500 powerhouse, has made a billion-dollar bet on that dream. So has a brash, young rival just 23 miles away in Cambridge, Mass. Moderna, a 10-year-old biotech company with billions in market valuation but no approved products, is racing forward with a vaccine of its own. Its new sprawling drug-making facility nearby is hiring workers at a fast clip in the hopes of making history — and a lot of money.

In many ways, the companies and their leaders couldn’t be more different. Pfizer, working with a little-known German biotech called BioNTech, has taken pains for much of the year to manage expectations. Moderna has made nearly as much news for its stream of upbeat press releases, executives’ stock sales, and spectacular rounds of funding as for its science.

Each is well-aware of the other in the race to be first.

But what the companies share may be bigger than their differences: Both are banking on a genetic technology that has long held huge promise but has so far run into biological roadblocks. It is called synthetic messenger RNA, an ingenious variation on the natural substance that directs protein production in cells throughout the body. Its prospects have swung billions of dollars on the stock market, made and imperiled scientific careers, and fueled hopes that it could be a breakthrough that allows society to return to normalcy after months living in fear.

Both companies have been frequently name-checked by President Trump. Pfizer reported strong, but preliminary, data on Monday, and Moderna is expected to follow suit soon with a glimpse of its data. Both firms hope these preliminary results will allow an emergency deployment of their vaccines — millions of doses likely targeted to frontline medical workers and others most at risk of Covid-19.

There are about a dozen experimental vaccines in late-stage clinical trials globally, but the ones being tested by Pfizer and Moderna are the only two that rely on messenger RNA.

For decades, scientists have dreamed about the seemingly endless possibilities of custom-made messenger RNA, or mRNA.

Researchers understood its role as a recipe book for the body’s trillions of cells, but their efforts to expand the menu have come in fits and starts. The concept: By making precise tweaks to synthetic mRNA and injecting people with it, any cell in the body could be transformed into an on-demand drug factory.

But turning scientific promise into medical reality has been more difficult than many assumed. Although relatively easy and quick to produce compared to traditional vaccine-making, no mRNA vaccine or drug has ever won approval.

Even now, as Moderna and Pfizer test their vaccines on roughly 74,000 volunteers in pivotal vaccine studies, many experts question whether the technology is ready for prime time.

“I worry about innovation at the expense of practicality,” Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine and an authority on vaccines, said recently. The U.S. government’s Operation Warp Speed program, which has underwritten the development of Moderna’s vaccine and pledged to buy Pfizer’s vaccine if it works, is “weighted toward technology platforms that have never made it to licensure before.”

Whether mRNA vaccines succeed or not, their path from a gleam in a scientist’s eye to the brink of government approval has been a tale of personal perseverance, eureka moments in the lab, soaring expectations — and an unprecedented flow of cash into the biotech industry.

It is a story that began three decades ago, with a little-known scientist who refused to quit.

Before messenger RNA was a multibillion-dollar idea, it was a scientific backwater. And for the Hungarian-born scientist behind a key mRNA discovery, it was a career dead-end.

Katalin Karikó spent the 1990s collecting rejections. Her work, attempting to harness the power of mRNA to fight disease, was too far-fetched for government grants, corporate funding, and even support from her own colleagues.

It all made sense on paper. In the natural world, the body relies on millions of tiny proteins to keep itself alive and healthy, and it uses mRNA to tell cells which proteins to make. If you could design your own mRNA, you could, in theory, hijack that process and create any protein you might desire — antibodies to vaccinate against infection, enzymes to reverse a rare disease, or growth agents to mend damaged heart tissue.

In 1990, researchers at the University of Wisconsin managed to make it work in mice. Karikó wanted to go further.

The problem, she knew, was that synthetic RNA was notoriously vulnerable to the body’s natural defenses, meaning it would likely be destroyed before reaching its target cells. And, worse, the resulting biological havoc might stir up an immune response that could make the therapy a health risk for some patients.

It was a real obstacle, and still may be, but Karikó was convinced it was one she could work around. Few shared her confidence.

“Every night I was working: grant, grant, grant,” Karikó remembered, referring to her efforts to obtain funding. “And it came back always no, no, no.”

By 1995, after six years on the faculty at the University of Pennsylvania, Karikó got demoted. She had been on the path to full professorship, but with no money coming in to support her work on mRNA, her bosses saw no point in pressing on.

She was back to the lower rungs of the scientific academy.

“Usually, at that point, people just say goodbye and leave because it’s so horrible,” Karikó said.

There’s no opportune time for demotion, but 1995 had already been uncommonly difficult. Karikó had recently endured a cancer scare, and her husband was stuck in Hungary sorting out a visa issue. Now the work to which she’d devoted countless hours was slipping through her fingers.

“I thought of going somewhere else, or doing something else,” Karikó said. “I also thought maybe I’m not good enough, not smart enough. I tried to imagine: Everything is here, and I just have to do better experiments.”

In time, those better experiments came together. After a decade of trial and error, Karikó and her longtime collaborator at Penn — Drew Weissman, an immunologist with a medical degree and Ph.D. from Boston University — discovered a remedy for mRNA’s Achilles’ heel.

The stumbling block, as Karikó’s many grant rejections pointed out, was that injecting synthetic mRNA typically led to that vexing immune response; the body sensed a chemical intruder, and went to war. The solution, Karikó and Weissman discovered, was the biological equivalent of swapping out a tire.

Every strand of mRNA is made up of four molecular building blocks called nucleosides. But in its altered, synthetic form, one of those building blocks, like a misaligned wheel on a car, was throwing everything off by signaling the immune system. So Karikó and Weissman simply subbed it out for a slightly tweaked version, creating a hybrid mRNA that could sneak its way into cells without alerting the body’s defenses.

“That was a key discovery,” said Norbert Pardi, an assistant professor of medicine at Penn and frequent collaborator. “Karikó and Weissman figured out that if you incorporate modified nucleosides into mRNA, you can kill two birds with one stone.”

That discovery, described in a series of scientific papers starting in 2005, largely flew under the radar at first, said Weissman, but it offered absolution to the mRNA researchers who had kept the faith during the technology’s lean years. And it was the starter pistol for the vaccine sprint to come.

And even though the studies by Karikó and Weissman went unnoticed by some, they caught the attention of two key scientists — one in the United States, another abroad — who would later help found Moderna and Pfizer’s future partner, BioNTech.

Derrick Rossi, a native of Toronto who rooted for the Maple Leafs and sported a soul patch, was a 39-year-old postdoctoral fellow in stem cell biology at Stanford University in 2005 when he read the first paper. Not only did he recognize it as groundbreaking, he now says Karikó and Weissman deserve the Nobel Prize in chemistry.

“If anyone asks me whom to vote for some day down the line, I would put them front and center,” he said. “That fundamental discovery is going to go into medicines that help the world.”

But Rossi didn’t have vaccines on his mind when he set out to build on their findings in 2007 as a new assistant professor at Harvard Medical School running his own lab.

He wondered whether modified messenger RNA might hold the key to obtaining something else researchers desperately wanted: a new source of embryonic stem cells.

In a feat of biological alchemy, embryonic stem cells can turn into any type of cell in the body. That gives them the potential to treat a dizzying array of conditions, from Parkinson’s disease to spinal cord injuries.

But using those cells for research had created an ethical firestorm because they are harvested from discarded embryos.

Rossi thought he might be able to sidestep the controversy. He would use modified messenger molecules to reprogram adult cells so that they acted like embryonic stem cells.

He asked a postdoctoral fellow in his lab to explore the idea. In 2009, after more than a year of work, the postdoc waved Rossi over to a microscope. Rossi peered through the lens and saw something extraordinary: a plate full of the very cells he had hoped to create.

Rossi excitedly informed his colleague Timothy Springer, another professor at Harvard Medical School and a biotech entrepreneur. Recognizing the commercial potential, Springer contacted Robert Langer, the prolific inventor and biomedical engineering professor at the Massachusetts Institute of Technology.

On a May afternoon in 2010, Rossi and Springer visited Langer at his laboratory in Cambridge. What happened at the two-hour meeting and in the days that followed has become the stuff of legend — and an ego-bruising squabble.

Langer is a towering figure in biotechnology and an expert on drug-delivery technology. At least 400 drug and medical device companies have licensed his patents. His office walls display many of his 250 major awards, including the Charles Stark Draper Prize, considered the equivalent of the Nobel Prize for engineers.

As he listened to Rossi describe his use of modified mRNA, Langer recalled, he realized the young professor had discovered something far bigger than a novel way to create stem cells. Cloaking mRNA so it could slip into cells to produce proteins had a staggering number of applications, Langer thought, and might even save millions of lives.

“I think you can do a lot better than that,” Langer recalled telling Rossi, referring to stem cells. “I think you could make new drugs, new vaccines — everything.”

Langer could barely contain his excitement when he got home to his wife.

“This could be the most successful company in history,” he remembered telling her, even though no company existed yet.

Three days later Rossi made another presentation, to the leaders of Flagship Ventures. Founded and run by Noubar Afeyan, a swaggering entrepreneur, the Cambridge venture capital firm has created dozens of biotech startups. Afeyan had the same enthusiastic reaction as Langer, saying in a 2015 article in Nature that Rossi’s innovation “was intriguing instantaneously.”

Within several months, Rossi, Langer, Afeyan, and another physician-researcher at Harvard formed the firm Moderna — a new word combining modified and RNA.

Springer was the first investor to pledge money, Rossi said. In a 2012 Moderna news release, Afeyan said the firm’s “promise rivals that of the earliest biotechnology companies over 30 years ago — adding an entirely new drug category to the pharmaceutical arsenal.”

But although Moderna has made each of the founders hundreds of millions of dollars — even before the company had produced a single product — Rossi’s account is marked by bitterness. In interviews with the Globe in October, he accused Langer and Afeyan of propagating a condescending myth that he didn’t understand his discovery’s full potential until they pointed it out to him.

“It’s total malarkey,” said Rossi, who ended his affiliation with Moderna in 2014. “I’m embarrassed for them. Everybody in the know actually just shakes their heads.”

Rossi said that the slide decks he used in his presentation to Flagship noted that his discovery could lead to new medicines. “That’s the thing Noubar has used to turn Flagship into a big company, and he says it was totally his idea,” Rossi said.

Afeyan, the chair of Moderna, recently credited Rossi with advancing the work of the Penn scientists. But, he said, that only spurred Afeyan and Langer “to ask the question, ‘Could you think of a code molecule that helps you make anything you want within the body?’”

Langer, for his part, told STAT and the Globe that Rossi “made an important finding” but had focused almost entirely “on the stem cell thing.”

Despite the squabbling that followed the birth of Moderna, other scientists also saw messenger RNA as potentially revolutionary.

In Mainz, Germany, situated on the left bank of the Rhine, another new company was being formed by a married team of researchers who would also see the vast potential for the technology, though vaccines for infectious diseases weren’t on top of their list then.

A native of Turkey, Ugur Sahin moved to Germany after his father got a job at a Ford factory in Cologne. His wife, Özlem Türeci had, as a child, followed her father, a surgeon, on his rounds at a Catholic hospital. She and Sahin are physicians who met in 1990 working at a hospital in Saarland.

The couple have long been interested in immunotherapy, which harnesses the immune system to fight cancer and has become one of the most exciting innovations in medicine in recent decades. In particular, they were tantalized by the possibility of creating personalized vaccines that teach the immune system to eliminate cancer cells.

Both see themselves as scientists first and foremost. But they are also formidable entrepreneurs. After they co-founded another biotech, the couple persuaded twin brothers who had invested in that firm, Thomas and Andreas Strungmann, to spin out a new company that would develop cancer vaccines that relied on mRNA.

That became BioNTech, another blended name, derived from Biopharmaceutical New Technologies. Its U.S. headquarters is in Cambridge. Sahin is the CEO, Türeci the chief medical officer.

“We are one of the leaders in messenger RNA, but we don’t consider ourselves a messenger RNA company,” said Sahin, also a professor at the Mainz University Medical Center. “We consider ourselves an immunotherapy company.”

Like Moderna, BioNTech licensed technology developed by the Pennsylvania scientist whose work was long ignored, Karikó, and her collaborator, Weissman. In fact, in 2013, the company hired Karikó as senior vice president to help oversee its mRNA work.

But in their early years, the two biotechs operated in very different ways.

In 2011, Moderna hired the CEO who would personify its brash approach to the business of biotech.

Stéphane Bancel was a rising star in the life sciences, a chemical engineer with a Harvard MBA who was known as a businessman, not a scientist. At just 34, he became CEO of the French diagnostics firm BioMérieux in 2007 but was wooed away to Moderna four years later by Afeyan.

Moderna made a splash in 2012 with the announcement that it had raised $40 million from venture capitalists despite being years away from testing its science in humans. Four months later, the British pharmaceutical giant AstraZeneca agreed to pay Moderna a staggering $240 million for the rights to dozens of mRNA drugs that did not yet exist.

The biotech had no scientific publications to its name and hadn’t shared a shred of data publicly. Yet it somehow convinced investors and multinational drug makers that its scientific findings and expertise were destined to change the world. Under Bancel’s leadership, Moderna would raise more than $1 billion in investments and partnership funds over the next five years.

Moderna’s promise — and the more than $2 billion it raised before going public in 2018 — hinged on creating a fleet of mRNA medicines that could be safely dosed over and over. But behind the scenes the company’s scientists were running into a familiar problem. In animal studies, the ideal dose of their leading mRNA therapy was triggering dangerous immune reactions — the kind for which Karikó had improvised a major workaround under some conditions — but a lower dose had proved too weak to show any benefits.

Moderna had to pivot. If repeated doses of mRNA were too toxic to test in human beings, the company would have to rely on something that takes only one or two injections to show an effect. Gradually, biotech’s self-proclaimed disruptor became a vaccines company, putting its experimental drugs on the back burner and talking up the potential of a field long considered a loss-leader by the drug industry.

Meanwhile BioNTech has often acted like the anti-Moderna, garnering far less attention.

In part, that was by design, said Sahin. For the first five years, the firm operated in what Sahin called “submarine mode,” issuing no news releases, and focusing on scientific research, much of it originating in his university lab. Unlike Moderna, the firm has published its research from the start, including about 150 scientific papers in just the past eight years.

In 2013, the firm began disclosing its ambitions to transform the treatment of cancer and soon announced a series of eight partnerships with major drug makers. BioNTech has 13 compounds in clinical trials for a variety of illnesses but, like Moderna, has yet to get a product approved.

When BioNTech went public last October, it raised $150 million, and closed with a market value of $3.4 billion — less than half of Moderna’s when it went public in 2018.

Despite his role as CEO, Sahin has largely maintained the air of an academic. He still uses his university email address and rides a 20-year-old mountain bicycle from his home to the office because he doesn’t have a driver’s license.

Then, late last year, the world changed.


Shortly before midnight, on Dec. 30, the International Society for Infectious Diseases, a Massachusetts-based nonprofit, posted an alarming report online. A number of people in Wuhan, a city of more than 11 million people in central China, had been diagnosed with “unexplained pneumonia.”

Chinese researchers soon identified 41 hospitalized patients with the disease. Most had visited the Wuhan South China Seafood Market. Vendors sold live wild animals, from bamboo rats to ostriches, in crowded stalls. That raised concerns that the virus might have leaped from an animal, possibly a bat, to humans.

After isolating the virus from patients, Chinese scientists on Jan. 10 posted online its genetic sequence. Because companies that work with messenger RNA don’t need the virus itself to create a vaccine, just a computer that tells scientists what chemicals to put together and in what order, researchers at Moderna, BioNTech, and other companies got to work.

A pandemic loomed. The companies’ focus on vaccines could not have been more fortuitous.

Moderna and BioNTech each designed a tiny snip of genetic code that could be deployed into cells to stimulate a coronavirus immune response. The two vaccines differ in their chemical structures, how the substances are made, and how they deliver mRNA into cells. Both vaccines require two shots a few weeks apart.

The biotechs were competing against dozens of other groups that employed varying vaccine-making approaches, including the traditional, more time-consuming method of using an inactivated virus to produce an immune response.

Moderna was especially well-positioned for this moment.

Forty-two days after the genetic code was released, Moderna’s CEO Bancel opened an email on Feb. 24 on his cellphone and smiled, as he recalled to the Globe. Up popped a photograph of a box placed inside a refrigerated truck at the Norwood plant and bound for the National Institute of Allergy and Infectious Diseases in Bethesda, Md. The package held a few hundred vials, each containing the experimental vaccine.

Moderna was the first drug maker to deliver a potential vaccine for clinical trials. Soon, its vaccine became the first to undergo testing on humans, in a small early-stage trial. And on July 28, it became the first to start getting tested in a late-stage trial in a scene that reflected the firm’s receptiveness to press coverage.

The first volunteer to get a shot in Moderna’s late-stage trial was a television anchor at the CNN affiliate in Savannah, Ga., a move that raised eyebrows at rival vaccine makers.

Along with those achievements, Moderna has repeatedly stirred controversy.

On May 18, Moderna issued a press release trumpeting “positive interim clinical data.” The firm said its vaccine had generated neutralizing antibodies in the first eight volunteers in the early-phase study, a tiny sample.

But Moderna didn’t provide any backup data, making it hard to assess how encouraging the results were. Nonetheless, Moderna’s share price rose 20% that day.

Some top Moderna executives also drew criticism for selling shares worth millions, including Bancel and the firm’s chief medical officer, Tal Zaks.

In addition, some critics have said the government has given Moderna a sweetheart deal by bankrolling the costs for developing the vaccine and pledging to buy at least 100 million doses, all for $2.48 billion.

That works out to roughly $25 a dose, which Moderna acknowledges includes a profit.

In contrast, the government has pledged more than $1 billion to Johnson & Johnson to manufacture and provide at least 100 million doses of its vaccine, which uses different technology than mRNA. But J&J, which collaborated with Beth Israel Deaconess Medical Center’s Center for Virology and Vaccine Research and is also in a late-stage trial, has promised not to profit off sales of the vaccine during the pandemic.

Over in Germany, Sahin, the head of BioNTech, said a Lancet article in January about the outbreak in Wuhan, an international hub, galvanized him.

“We understood that this would become a pandemic,” he said.

The next day, he met with his leadership team.

“I told them that we have to deal with a pandemic which is coming to Germany,” Sahin recalled.

He also realized he needed a strong partner to manufacture the vaccine and thought of Pfizer. The two companies had worked together before to try to develop mRNA influenza vaccines. In March, he called Pfizer’s top vaccine expert, Kathrin Jansen.

“I asked her if Pfizer was interested in teaming up with us, and she, without any discussion, said, ‘Yes, we would love to do that,’” Sahin recalled.

Philip Dormitzer, chief scientific officer for viral vaccines at Pfizer, said developing a coronavirus vaccine is “very much in Pfizer’s comfort zone as a vaccine company with multiple vaccine products.”

Pfizer has about 2,400 employees in Massachusetts, including about 1,400 at its Andover plant, one of three making the vaccine for the New York-based company in the U.S.

Pfizer, through its partnership with BioNTech, isn’t taking any money upfront from the government. Rather, the federal government will pay the partners $1.95 billion for at least 100 million doses if the vaccine gets approved.

Pfizer CEO Albert Bourla, who rose through the ranks after more than 25 years with the company, said in a September interview with “Face the Nation” that if the Pfizer-BioNTech vaccine fails, his company will absorb the financial loss. He said Pfizer opted not to take government funding up front to shield the drug giant from politics.

“I wanted to liberate our scientists from any bureaucracy,” he said. “When you get money from someone, that always comes with strings.”

Top executives at Pfizer also have sold far less stock compared to Moderna since the pandemic began.

BioNTech executives haven’t sold any shares since the company went public last year, according to Securities and Exchange Commission records. Still, the soaring share prices of BioNTech and Moderna have made both Sahin and Bancel billionaires, according to Forbes.

Some experts worry about injecting the first vaccine of this kind into hundreds of million of people so quickly.

“You have all these odd clinical and pathological changes caused by this novel bat coronavirus, and you’re about to meet it with all of these vaccines with which you have no experience,” said Paul Offit, an infectious disease expert at Children’s Hospital of Philadelphia and an authority on vaccines.

Several other drug makers have also developed experimental mRNA vaccines for the coronavirus, but are not as far along, including CureVac, another German biotech, and Translate Bio, which has partnered with the French vaccine giant Sanofi Pasteur.

Pfizer began its late-stage trial on July 27 — the same day as Moderna — with the first volunteers receiving injections at the University of Rochester. It announced its promising early results from that trial on Monday, and hopes to have sufficient data this month to seek emergency use authorization of the vaccine for at least some high-risk people.

Moderna may not be far behind. Its spokesperson Ray Jordan said Monday that executives suspected Pfizer would release some preliminary late-stage trial data before Moderna, in part because of the dosing schedule of the rival vaccines. Recipients of Pfizer’s vaccine get two doses three weeks apart, while recipients of Moderna’s get two doses four weeks apart.

Striking a magnanimous note, he described Pfizer’s news as “an important step for mRNA medicine.”

“We’ve said that the world needs more than one Covid-19 vaccine,” Jordan said. “We remain on track.”
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Re: We could soon have vaccines for cancer and HIV thanks to COVID-19 vaccine discovery: report

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Two studies find that COVID-19 antibodies last 8 months

https://www.cidrap.umn.edu/news-perspec ... t-8-months


Two studies published yesterday demonstrate that COVID-19 immune responses last as long as 8 months, although the authors focus on different reasons.

The first study, published in Science Immunology, followed a small cohort of Australians from day 4 to day 242 after infection. All patients demonstrated the presence of memory B cells—immune cells that "remember" viral proteins and can trigger rapid production of antibodies when re-exposed to the virus—as long as 8 months after initial infection.

The second study investigated antibody responses in 58 confirmed COVID-19 patients in South Korea 8 months after asymptomatic or mild SARS-CoV-2 infection, finding high rates of serum antibodies. These results, published in Emerging Infectious Diseases, are contradictory to both the first study's antibody data and previous research that showed antibodies waning after 20 days, but the authors suggest that variations in immunoassay test characteristics and manufacturing may be responsible for the difference.
Memory B cells key to detecting immune response

For the Australian study, researchers obtained blood samples from 25 confirmed COVID-19 patients with a range of disease severities and 36 healthy control patients from March to September, evaluating each patient's antibody status and levels of virus-specific immune cells.

The study authors found that by day 6 post-infection, all patients showed immunoglobulin (Ig) G antibodies for the viral receptor-binding domain—a protein on the viral surface that binds to cell receptors, allowing entry and infection—and the nucleocapsid protein, the protective protein shell of the virus. Patient IgG levels began declining 20 days after symptom onset.

In contrast, the study authors found that memory B cell levels continued to rise up to 150 days post-infection and remained detectable 240 days post-symptom onset, suggesting that patient immune systems were primed to respond to reinfection. Because of their extended presence, the cells may be a better indicator of long-term immune response than serum antibodies, the authors say.

The study results provide hope that vaccines will generate a similar duration of protection, and the authors say cellular immunity may explain why there are few documented cases of reinfection with SARS-CoV-2.

"These results are important because they show, definitively, that patients infected with the COVID-19 virus do in fact retain immunity against the virus and the disease," said senior author Menno van Zelm, PhD, in a Monash University news release yesterday.

"This has been a black cloud hanging over the potential protection that could be provided by any COVID-19 vaccine and gives real hope that, once a vaccine or vaccines are developed, they will provide long-term protection."
Antibodies 8 months after infection in Korea

In the second study, the researchers measured SARS-CoV-2–specific antibodies using four commercial immunoassay tests in isolated patients at a Seoul National University Hospital community treatment center from Mar 5 to Apr 9. Three of the four assays showed high seropositivity rates (69% to 91.4%; P < 0.01), in contrast to yet another earlier study showing that asymptomatic patients become seronegative by 2 to 3 months post-infection.

"Rates differed according to immunoassay methods or manufacturers, thereby explaining differences in rates between the studies," the authors wrote. For instance, they said, a July BMJ study reported chemiluminescent immunoassay tests had 97.8% IgG or IgM sensitivity, whereas enzyme-linked immunosorbent assay tests only had 84.3%.

Virus neutralizing activity—essential for protection from reinfection—was detected in only 53.4% of study participants at 8 months post-infection, considerably lower than the rate of positivity for immunoassays.

"Despite concerns of waning immunity, appropriate immunoassays can detect antibodies against SARS-CoV-2 at 8 months after infection in most asymptomatic or mildly symptomatic persons," the authors concluded.
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Re: We could soon have vaccines for cancer and HIV thanks to COVID-19 vaccine discovery: report

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Feature Article: Long-term Side Effects of COVID-19 Vaccine? What We Know.

4/4/21


https://www.chop.edu/news/long-term-sid ... 19-vaccine


Since COVID-19 mRNA vaccines are new, some people have asked about their effects on those who take them. Short-term side effects (i.e., those that happen in the days after a vaccine has been given) are readily apparent because of clinical trial reports and personal experiences, but people also wonder about possible long-term effects of these vaccines. To answer this question, scientists study the available evidence, and while the rules of science do not allow scientists to say that long-term effects can never happen, the evidence is strong that mRNA vaccines will not cause long-term harm.

The evidence


Vaccine history

The history of vaccines shows that delayed effects following vaccination can occur. But when they do, these effects tend to happen within two months of vaccination:

Oral polio vaccine — About 1 in 2.4 million recipients of the oral polio vaccine, which is no longer used in the U.S., were paralyzed following vaccination when the vaccine virus reverted to “wild type” poliovirus. This happened when genetic changes to weaken the virus in the lab were lost during viral replication in the vaccine recipient. Paralysis occurred about seven to 30 days (one to four weeks) after vaccination. Because vaccine recipients “shed” the virus in their stools, on occasion, contacts of these people would be paralyzed when they were infected, and the genetic reversion occurred in them. This secondary event could happen up to 60 days (eight to nine weeks) after the first person was vaccinated (because it took time for the virus to spread to the next person).
Yellow fever vaccine — The yellow fever vaccine is not routinely recommended in the U.S., but it is required for travel to certain countries. Two delayed negative effects have been detected after receipt of this vaccine:
Nervous system involvement — This effect causes swelling of the brain or spinal cord. It occurred most often when infants younger than 6 months of age received this vaccine, which is why this group is not recommended to get the vaccine. It can also happen, albeit less frequently, in those older than 6 months of age who receive the vaccine. When this happens, the average time between receipt of the vaccine and symptom onset is two weeks, with the range up to three weeks.
Viscerotropic disease — This condition is characterized by multisystem organ failure. Yellow fever infection can also cause multisystem organ failure. This adverse event happened so infrequently that it was not described until the early 2000s. In this situation, vaccine virus replicates and spreads throughout the body; onset occurs less than one week after vaccination, most often, occurring about three days after receipt of the vaccine.
Influenza vaccine — Two severe adverse events associated with influenza vaccine are also instructive:
A 1976 swine influenza vaccine was identified as a rare cause of Guillain-Barré Syndrome (GBS), an ascending paralysis that can involve the muscles of breathing; however, subsequent studies have not found flu vaccines to be a cause of GBS. In contrast, influenza infection is also a cause of GBS. GBS occurs 17 times more frequently after natural infection than vaccination. Almost all cases following vaccination occurred in the eight weeks after receipt of the vaccine.
In 2009, during the H1N1 pandemic, one influenza vaccine used in Finland was found to cause narcolepsy in about 1 in 55,000 vaccine recipients. Narcolepsy is a sleep disorder characterized by excessive fatigue and periods of sleep throughout the day. Despite various influenza vaccines used during the pandemic, only one caused this issue, which was believed to have resulted from the way that particular vaccine was made. The average onset of symptoms occurred within seven weeks of vaccination.
MMR vaccine — About 1 of 30,000 recipients of measles, mumps and rubella (MMR) vaccine can experience a temporary decrease in platelets; a condition called thrombocytopenia. Platelets are the cells responsible for clotting of blood. Both measles and mumps infections can cause thrombocytopenia. This condition is most often found between one and three weeks after vaccination, but in a few cases, it occurred up to eight weeks after vaccination.

These experiences demonstrate two important findings. First, when these events occurred, the onset was within eight weeks of receipt of the vaccine. Second, in all of these cases, except narcolepsy following H1N1 vaccine, the side effect of the vaccine was something that could be caused by the infection, meaning that getting infected with the virus also carried a risk of experiencing these outcomes. In the narcolepsy experience, the cause was determined to be related to the adjuvant used in that preparation of vaccine.

Regardless, this history humbles vaccine scientists. They know that they hold people’s lives in their hands. As stated by Dr. Maurice Hilleman, perhaps the most prolific vaccine scientist in history, “I never breathe a sigh of relief until the first few million doses are out there,” (Personal communication, Paul Offit, 2004). For this reason, scientists and public health officials carefully analyze and continually monitor the data related to every vaccine before, during and after it becomes available.
mRNA vaccine

Even with this history in mind, some reasonably wonder about the mRNA vaccines because they have not previously been approved for use in people. But here, too, we can be confident in what we know:

Although COVID-19 mRNA vaccines are new, this type of vaccine has been studied in people before. mRNA vaccines against HIV, rabies, Zika and flu have been tested in phase 1 and phase 2 trials in people. The technology has also been used in clinical trials as a way to treat some cancers. Even though these products have not been licensed for use in people, these efforts provided important information about mRNA technology and its safety.
mRNA is made and used in protein production in all cells of our bodies. As such, cells have mechanisms in place to ensure that no protein is made in quantities greater than needed. One way this happens is that mRNA has a “poly(A) tail.” In the cytoplasm, this tail ensures mRNA decay. As the mRNA is used to make proteins in the cell, the length of the poly(A) tail decreases, until it is too short for the mRNA to continue being used as a protein blueprint. Once this happens, the mRNA breaks down and is removed as cellular debris. This process limits how long mRNA remains in the cytoplasm — and, therefore, how much protein is produced.

As such, poly(A) tails ensure that the cell breaks down the vaccine mRNA in a timely manner. Likewise, this understanding allows scientists to design vaccine-delivered mRNA in a way that ensures it does not stay in the cell longer than needed to generate immunity.
Because of the knowledge gained with other vaccines, the Food and Drug Administration (FDA) required companies making COVID-19 vaccines to follow trial participants for a minimum of eight weeks before they could submit their data for approval. Likewise, the participants in the mRNA vaccine trials continue to be followed even though the vaccines have been approved for use.

While concerns about long-term effects of vaccines are legitimate, it is important to be aware that the organized anti-vaccine industry has targeted this issue as a way to sow doubt and confusion about COVID-19 vaccines. According to the Center for Countering Digital Hate, professional anti-vaccine activists organized a meeting in the fall of 2020 to create messaging that would decrease acceptance of COVID-19 vaccines once available. These organized efforts aim to move people to extreme positions about vaccines — that is to say, from having legitimate questions about vaccines to becoming “anti-vaccine,” refusing all vaccines and believing conspiracy theories and false narratives. In some cases, individuals in these groups do not believe the science, and in other cases, they are seeking to profit from this hesitancy by encouraging the use of other products to “protect” against COVID-19.

With this in mind, we recommend carefully vetting sources of information, and the statements they are making, to ensure that you are getting answers from reliable sources.
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Major European nations suspend AstraZeneca vaccination over fears of side effects


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"A big hit to the vaccine campaign": Doctor on Johnson & Johnson's vaccine delivery plunge

https://finance.yahoo.com/video/big-hit ... 20798.html
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The Shock and Reality of Catching Covid After Being Vaccinated

4/16/21


https://khn.org/news/article/the-shock- ... accinated/


Robin Hauser, a pediatrician in Tampa, Fla., got covid in February. What separates her from the vast majority of the tens of millions of other Americans who have come down with the virus is this: She got sick seven weeks after her second dose of the Pfizer-BioNTech vaccine.

“I was shocked,” said Hauser. “I thought: ‘What the heck? How did that happen?’ I now tell everyone, including my colleagues, not to let their guard down after the vaccine.”

As more Americans every day are inoculated, a tiny but growing number are contending with the disturbing experience of getting covid despite having had one shot, or even two.

In data released Thursday, the Centers for Disease Control and Prevention reported that at least 5,800 people had fallen ill or tested positive for the coronavirus two weeks or more after they completed both doses of the Pfizer-BioNTech or Moderna vaccine.

A total of about 78 million Americans are now fully vaccinated.

These so-called breakthrough infections occurred among people of all ages. Just over 40% were in people age 60 or older, and 65% occurred in women. Twenty-nine percent of infected people reported no symptoms, but 7% were hospitalized and just over 1%, 74 people, died, according to the CDC.

Public health officials have said breakthrough infections were expected, since manufacturers have warned loudly and often that the vaccines are not 100% protective. The Pfizer and Moderna versions have consistently been shown to be above 90% effective, most recently for at least six months. Studies have also shown they are nearly 100% effective at ensuring that the small fraction of vaccinated patients who do contract the virus will not get severe cases or require hospitalization.

Still, people are usually shocked and befuddled when they become the rare breakthrough victim. After months of fear and taking precautions to avoid contracting covid, they felt safe once they got their shots.

Hauser, 52, had stayed home from work to care for her kids, ages 21 and 16, both of whom had contracted the virus. She was confident she was protected. She was also taking care of her father, who has cancer.

“It’s a minor miracle that I didn’t infect him before I realized I, too, was sick,” Hauser said. In keeping with the virus’s fickle behavior, Hauser’s husband, Brian, who had not yet been vaccinated, also never got infected.

Masha Gessen, a staff writer for The New Yorker, completed the two-shot process in mid-February. A month later, Gessen fell ill and tested positive after both Gessen’s son and partner, Julia Loktev, had weathered bouts of covid. The experience was “unsettling, even a bit traumatic,” Gessen said. Loktev’s illness occurred six days after her first dose.

“The psychological effect of getting the virus after a year of being very, very careful and getting vaccinated got to me,” Gessen, 54, said in an interview with KHN. “It took me about three weeks to feel back to normal.” Gessen wrote about the experience this month in The New Yorker.

Dr. Kami Kim, director of the infectious disease and international medicine division at the University of South Florida in Tampa, said physicians are equally disturbed when these cases crop up.

“All this, while anticipated, is definitely confusing and frustrating for people, both doctors and patients. We are all learning on the go and making judgments about what’s best for our patients—and ourselves,” Kim said.

Vaccine manufacturers said the number of breakthrough cases reported by the CDC was not surprising.

Moderna’s latest analysis of its vaccine clinical trial data shows 900 people got covid after being vaccinated, consistent with 90% or more efficacy for the vaccine, company spokesperson Colleen Hussey said.

Pfizer spokesperson Jerica Pitts said the company would monitor trial participants for two years after their second dose to learn more about the Pfizer vaccine’s protection against covid.

In their reporting, the CDC is defining a breakthrough case strictly as illness or a positive test two weeks or more after full vaccination. But tens of thousands of people who have had a first shot or are short of two weeks after their second shot are also getting infected.

Pfizer and Moderna report data showing up to 80% protection from infection two weeks or so after the first shot. But most experts believe protection ranges widely, from 50% to 80%, depending on the length of time after the shot and the individual variation that exists with any vaccine.

The second shot boosts immunity further but not for a few days, at minimum, and then builds over two weeks. And again, this could vary from person to person.

Leslie Fratkin, 60, a freelance photographer in New York City, got her second Pfizer dose March 12. So she was surprised when clear symptoms of covid showed up March 24 and she was quite sick at home for three days.

“You can’t print the words I uttered at the time,” she said.

The CDC advises people who get covid after a first shot to get the second dose soon after recovery, with no minimum wait time specified.That’s a change from prevalent advice back in December and January, when some state health departments advised people to wait 90 days after a bout of covid to get a first or second shot, and especially a second shot.

Driving this important change is mounting evidence from studies and experience indicating that immunity to infection conferred by the vaccines is stronger and possibly more “stable” over time than immunity derived from covid infection.

Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis, said further research and better public health guidance are urgently needed. For example, is a second dose even needed for people who get covid after the first dose, or does the infection itself serve as enough of an immune system booster? And if a second shot is recommended, what’s the optimal waiting period before getting it?

“These are important practical questions that need to be prioritized,” Osterholm said. “We are sort of flying blind now.”

Other countries have handled the second dose rollout differently.

In the U.K., health authorities delayed it up to 12 weeks, to stretch vaccine supply and prioritize getting at least one shot into more people’s arms more quickly. In Canada, a government vaccine advisory committee recommended April 7 that second doses be delayed up to four months.

At two press briefings this month, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and a covid adviser to President Joe Biden, said that the number of breakthrough cases in the U.S. so far is not cause for alarm and that the administration will continue to monitor these instances closely.

One important line of investigation is how much of a role variants or mutated versions of the initial coronavirus play in these breakthrough cases. Research suggests the current vaccines may be somewhat less effective against some new variants.

Martha Sharan, a CDC spokesperson, said the agency is now urging states to use genetic sequencing to test virus specimens from patients with breakthrough cases to identify variants. In Washington state, for instance, eight variants were detected in the genetic sequencing of nine breakout cases reported through April 3.

The Biden administration today announced $1.7 billion in spending would be directed from the covid relief bill to help the CDC, states and other jurisdictions more effectively detect and track variants by scaling genomic sequencing efforts.

The CDC also has launched a national covid vaccine breakthrough database where state health departments can store and manage data.

“We are behind on sequencing samples,” said Osterholm. “That will give us valuable information.”
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April 14th: Vaccine DEATH WAVE now unstoppable… 122 million Americans now at risk from dangerous medical experiment that can’t be undone

https://www.naturalnews.com/2021-04-14- ... icans.html


(Natural News) According to the CDC Covid Data Tracker page, over 122 million Americans have already received at least one dose of a covid vaccine. That’s about 37% of the population, and it’s increasing by nearly 2 million people per day in the United States.

Notably, as Americans are being killed by vaccines, globalists are replacing the American electorate by bringing in massive waves of illegal aliens, many of whom are pregnant women ready to give birth to anchor babies. The criminal Marxists who stole the 2020 election are continuing their plan to mass murder real Americans (with vaccines and bioweapons) and replace them with compliant, low-skilled illegals who will vote for socialist handouts and freedom-killing Democrat policies.

Both Johnson & Johnson and AstraZeneca vaccines are causing deaths via blood clots, obviously because the spike protein antibody causes blood clots that travel to the heart, lungs and brain, killing patients from the clots. Yesterday, the FDA ordered a nationwide halt to the J&J vaccine because so many people were dying. But even the mRNA vaccines also create spike proteins that are coagulants, contributing to the blood clots that can be fatal.

What’s shockingly obvious at this point is that an insane vaccine experiment has been unleashed in America, and there’s no way to undo it. Now, over 122 million Americans will be subject to the risk of blood clots, medium-term inflammation effects and hyperinflammatory reactions to future pathogens that are likely to appear this coming Fall and Winter. No one knows for sure how many will die, but it looks rather likely that the vaccine may end up killing far more people than the coronavirus pathogen.

Almost no one who took the vaccine has any clue that the vaccines were never subjected to traditional large-scale, long-term clinical trials. They are utterly unaware that the FDA only allowed the vaccines under “emergency authorization” use, which by definition means the vaccines are medical experiments. The term “oblivious” barely begins to describe the shocking lack of knowledge under which vaccine recipients suffer, even as they tell themselves they are “smart” or “healthy” for participating in Big Pharma’s global depopulation and infertility experiment.

Importantly, once a person’s immune system is compromised with these vaccine injections, there’s no way to undo the damage. Those vaccine victims are now damaged for life, and even if they later learn the truth about the vaccine depopulation agenda, there’s no treatment, supplement or technology in existence that can restore their body to a pre-vaccination status. They have unwittingly signed their own death warrants, all while gleefully thinking they’re going to win their freedom with tyrannical vaccine passports.
How many millions will die from the covid vaccine over the next 2-3 years? What will happen to society when then death wave kicks in?

In today’s Situation Update podcast, I ask the important question of how many millions will die from the vaccine in the next few years. We must also consider how many people will become infertile (both men and women, and no, there isn’t any other gender).

The globalists built the covid bioweapon and released it upon the world precisely to push for mandatory vaccines that are deliberately designed to achieve global depopulation. And it seems there are likely 150 – 200 million Americans who are dumb enough to volunteer to be human guinea pigs in a deadly depopulation medical experiment that’s specifically designed to eliminate people who are stupid enough to participate in it.

Today’s Situation Update podcast tells the full story:
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J&J, AstraZeneca Covid-19 jabs both contain aborted human fetal tissue

4/15/21


https://pandemic.news/2021-04-15-jj-ast ... issue.html


Some leaders in the Roman Catholic Church are warning their laity not to be injected with experimental Wuhan coronavirus (Covid-19) chemicals from Johnson & Johnson (J&J) or AstraZeneca because the jabs contain ingredients derived from aborted human babies.

Archbishop Allen H. Vigneron and a coalition of six other Catholic leaders across the state of Michigan say that many people do not even know the so-called “vaccines” contain aborted fetal tissue because public health officials are failing to be honest and transparent about it.

“They utilized in the design, production, development, and confirmatory testing a cell line that originated from tissue taken from an aborted baby,” the Catholic leaders warn about the two injections from J&J and AstraZeneca. “These vaccines may be received only if there are no other alternatives.

To learn more about the dangers and ineffectiveness of vaccines made from aborted human fetal tissue, visit ChemicalViolence.com.

Catholic leaders say it’s “morally permissible” to become a GMO human with Pfizer, Moderna jabs

As for the more widely administered messenger RNA (mRNA) injections made by Pfizer-BioNTech and Moderna, the Catholic leaders say that these are preferable because neither of them contains cell lines originating in tissue that was taken from aborted babies.

“It is morally permissible to receive the vaccines developed by Pfizer and Moderna,” they declared.

Even though both the Pfizer-BioNTech and Moderna jabs were tested using cell lines from aborted fetal tissue, the Catholic leaders claim that this “connection to the abortion is very remote,” and thus morally acceptable in the eyes of the god of Roman Catholicism.

“… it is important to keep in mind that there are varying levels of responsibility,” they claim as justification for why the one pair of jabs is “better” than the other pair.

“Greater moral responsibility lies with the researchers than with those who receive the vaccine.”

Because J&J and AstraZeneca directly synthesized aborted baby body parts into their vaccine formulas as opposed to just using the tissue for testing purposes like Pfizer-BioNTech and Moderna did, the latter companies’ injections are what Catholics should opt for, if possible, the leaders say.

“The vaccines developed by Johnson & Johnson and AstraZeneca are more morally problematic.

Big Tech censoring personal reports about health damage caused by Covid-19 injections

As for the litany of health risks associated with all of these injections, the Catholic leaders failed to warn their laity about any of them, instead choosing to focus on the “immorality” of choosing J&J or AstraZeneca over Pfizer-BioNTech or Moderna.

This could be due to the fact that reports about serious adverse events caused by the injections are being silenced all across social media, including on Facebook where users’ personal reports about side effects are being “fact-checked” or censored.

According to reports, Facebook “fact-checked” a woman’s post about the serious adverse reactions she suffered immediately after getting injected. One week later, she passed away.

On March 10, Denise Penrod wrote about multiple side effects she suffered after getting jabbed:

‘The vaccine is killing me today. My arm hurts, beyond exhausted, headache, stomach cramps and earaches. Multiple people told me that I looked pale today. Yesterday, I was fine but today it’s taking a toll on me.”

Facebook quickly plastered up a warning over Penrod’s post stating that “COVID-19 vaccines go through many tests for safety and effectiveness before they’re approved. Source: World Health Organization.”

Just a few days later, Penrod’s “safe and effective” vaccine injection killed her, defying Facebook’s claim that this is impossible because of all the “tests for safety and effectiveness” that her jab supposedly underwent before being plunged into her arm.
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Re: We could soon have vaccines for cancer and HIV thanks to COVID-19 vaccine discovery: report

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Spike proteins in Pfizer, Moderna Covid-19 vaccines linked to deadly blood clots, brain inflammation and heart attacks

4/16/21


https://vaccines.news/2021-04-16-spike- ... ation.html


The media is giving considerable airtime to the deadly blood clot issue with Wuhan coronavirus (Covid-19) injections from AstraZeneca and Johnson & Johnson (J&J), both of which are manufactured using adenovirus technology. New evidence, though, shows that the messenger RNA (mRNA) injections from Pfizer-BioNTech and Moderna can cause the same issues and more.

Dr. J. Patrick Whelan, a pediatric rheumatologist, warned the Food and Drug Administration (FDA) back in December that mRNA injections have the potential to cause microvascular injury to the brain, heart, liver and kidneys – and in ways that were not even assessed during safety trials.

On Dec. 8, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) released a public submission from Whelan that was a response to the agency’s request for comments regarding so-called “vaccines” for the Chinese Virus. This occurred in anticipation of a Dec. 10 meeting at which the committee was scheduled to review the Pfizer-BioNTech injection for emergency use authorization (EUA).

In his public submission, Whelan, a veteran physician with decades of experience in his field, alerted the FDA to these potential vaccine injuries, noting that the spike protein component of the jabs is a potential trigger for serious injuries.

Whelan explained that experimental mRNA technology has “the potential to cause microvascular injury (inflammation and small blood clots called microthrombi) to the brain, heart, liver and kidneys in ways that were not assessed in the safety trials.”

Nowhere in his alert did Whelan suggest that the “vaccines” might not work to quickly arrest the spread of the virus, but rather he warned that “it would be vastly worse if hundreds of millions of people were to suffer long-lasting or even permanent damage to their brain or heart microvasculature as a result of failing to appreciate in the short-term an unintended effect of full-length spike protein-based vaccines on other organs.”
mRNA “vaccine” spike proteins found to cross blood-brain barrier

Whelan provided a plethora of evidence and pertinent information to back his warning, which the FDA patently ignored. Instead, the FDA chose to rely on very limited clinical trial data provided by the jabs’ manufacturers as “evidence” that they are “safe and effective” enough to warrant an EUA designation.

The very next day, in fact, the FDA issued an EUA to Pfizer-BioNTech, effectively slapping Whelan in the face, along with the rest of America. The FDA was dead-set on getting Donald Trump’s “Operation Warp Speed” injections distributed as quickly as possible, and nothing was going to get in the way of that.

A few days after Whelan submitted his letter to the FDA, the journal Nature Neuroscience determined that the commercially obtained Wuhan coronavirus (Covid-19) spike proteins (S1) found in vaccines readily cross the blood-brain barrier. These spike proteins were found in all 11 regions of the brain that were examined, including the parenchymal brain space where functional tissue is located.

This easy entry of vaccine spike proteins into the brain could explain the diverse neurological effects that have been observed in conjunction with the jabs. Such effects include encephalitis, respiratory difficulties and anosmia, or loss of smell. Researchers also found vaccine spike proteins in lung, spleen, kidney and liver tissue of mice.

A second study published not long after in the journal Neurobiology of Disease found that Chinese virus jab spike proteins have a direct negative impact on endothelial cells. This, that research team found, provides “plausible explanations” for the neurological consequences observed in some patients who test “positive” for the Wuhan coronavirus (Covid-19).

All of this and more is why Whelan expressed concerns to the FDA about the artificial spike proteins used in mRNA injections, which have the potential to damage major bodily organs.
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