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J&J CSO Claims Single Dose COVID-19 Vaccine on Track for March Rollout

J& J is on track to roll out a single-shot coronavirus vaccine in March, and plans to have clear data on how effective it is by the end of January or early February

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This article was originally published by PharmaLive.

J&J COVID-19 vaccine on track for March rollout, still aims for 1 billion doses this year: executive

CHICAGO (Reuters) – Johnson & Johnson is on track to roll out its single-shot coronavirus vaccine in March, and plans to have clear data on how effective it is by the end of this month or early February, the U.S. healthcare company’s chief science officer said.

Dr. Paul Stoffels in an interview on Tuesday also said J&J expects to meet its stated target of delivering 1 billion doses of its vaccine by the end of this year as the company ramps up production.

The New York Times reported earlier on Wednesday that J&J was experiencing manufacturing delays that would reduce the number of doses initially available. Stoffels declined to say how many doses would be ready to go into people’s arms in March, presuming it receives emergency authorization from the U.S. Food and Drug Administration.

“We are aiming for 1 billion doses in 2021. If it is a single dose, that means 1 billion people. But it will be in a ramp-up throughout the year,” Stoffels said.

Initial launch capacity depends in part on validation of manufacturing plants, he added. The company is scaling up efforts to both produce the active vaccine and the means to package and ship it in large quantities.

Johnson & Johnson’s vaccine is being produced in the United States, Europe, South Africa and India with the help of contract manufacturers in order to build capacity.

FILE PHOTO: Paul Stoffels, Chief Scientific Officer of Johnson & Johnson attends the annual meeting of the World Economic Forum (WEF) in Davos, Switzerland January 22, 2016. REUTERS/Ruben Sprich

“It’s a few weeks too early to be giving final numbers on what we can launch in the first couple months,” he said.

Although J&J’s clinical trial protocols allowed for an early look at the data after 20 people became infected by the novel coronavirus, the company intends to deliver data on at least 154 confirmed cases – the target needed to fully assess the vaccine’s efficacy – when it releases results. That should come in the last week of January or the first week of February, Stoffels said.

The U.S. Food and Drug Administration requires at least two months of safety data on half of the study participants to ensure no unexpected side effects crop up, as well as data on specific populations such as the elderly. The company crossed that two-month threshold earlier this month.

“That point came so close to the final analysis that we decided not to do an interim analysis,” Stoffels said.

A surge in COVID-19 cases in the fall that exceeded J&J’s initial projections allowed the company to reduce the number of study volunteers to 40,000 from the initially planned 60,000 participants. Data can be collected faster when community transmission is widespread during testing.

J&J plans to seek emergency use authorization from the FDA based on the study of the vaccine as a single shot, Stoffels said. If results of ongoing studies suggest people would fare better with a second booster shot, Stoffels said J&J would file separately for a booster dose authorization.

The company is closely monitoring changes or mutations in the virus that might affect the vaccine’s effectiveness.

Scientists are particularly concerned about a highly transmissible variant of the virus first discovered in South Africa that could affect how well vaccines protect against it.

Because part of J&J’s clinical trial is being conducted in South Africa, Stoffels said the company should have data on how its vaccine fares against this new variant.

Reporting by Julie Steenhuysen; Editing by Bill Berkrot
Reuters source: https://www.reuters.com/article/us-health-coronavirus-johnson-johnson/jj-covid-19-vaccine-on-track-for-march-rollout-still-aims-for-1-billion-doses-this-year-executive-idUSKBN29I2GS

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AI vs. elections: 4 essential reads about the threat of high-tech deception in politics

Using disinformation to sway elections is nothing new. Powerful new AI tools, however, threaten to give the deceptions unprecedented reach.

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Like it or not, AI is already playing a role in the 2024 presidential election. kirstypargeter/iStock via Getty Images

It’s official. Joe Biden and Donald Trump have secured the necessary delegates to be their parties’ nominees for president in the 2024 election. Barring unforeseen events, the two will be formally nominated at the party conventions this summer and face off at the ballot box on Nov. 5.

It’s a safe bet that, as in recent elections, this one will play out largely online and feature a potent blend of news and disinformation delivered over social media. New this year are powerful generative artificial intelligence tools such as ChatGPT and Sora that make it easier to “flood the zone” with propaganda and disinformation and produce convincing deepfakes: words coming from the mouths of politicians that they did not actually say and events replaying before our eyes that did not actually happen.

The result is an increased likelihood of voters being deceived and, perhaps as worrisome, a growing sense that you can’t trust anything you see online. Trump is already taking advantage of the so-called liar’s dividend, the opportunity to discount your actual words and deeds as deepfakes. Trump implied on his Truth Social platform on March 12, 2024, that real videos of him shown by Democratic House members were produced or altered using artificial intelligence.

The Conversation has been covering the latest developments in artificial intelligence that have the potential to undermine democracy. The following is a roundup of some of those articles from our archive.

1. Fake events

The ability to use AI to make convincing fakes is particularly troublesome for producing false evidence of events that never happened. Rochester Institute of Technology computer security researcher Christopher Schwartz has dubbed these situation deepfakes.

“The basic idea and technology of a situation deepfake are the same as with any other deepfake, but with a bolder ambition: to manipulate a real event or invent one from thin air,” he wrote.

Situation deepfakes could be used to boost or undermine a candidate or suppress voter turnout. If you encounter reports on social media of events that are surprising or extraordinary, try to learn more about them from reliable sources, such as fact-checked news reports, peer-reviewed academic articles or interviews with credentialed experts, Schwartz said. Also, recognize that deepfakes can take advantage of what you are inclined to believe.


Read more: Events that never happened could influence the 2024 presidential election – a cybersecurity researcher explains situation deepfakes


How AI puts disinformation on steroids.

2. Russia, China and Iran take aim

From the question of what AI-generated disinformation can do follows the question of who has been wielding it. Today’s AI tools put the capacity to produce disinformation in reach for most people, but of particular concern are nations that are adversaries of the United States and other democracies. In particular, Russia, China and Iran have extensive experience with disinformation campaigns and technology.

“There’s a lot more to running a disinformation campaign than generating content,” wrote security expert and Harvard Kennedy School lecturer Bruce Schneier. “The hard part is distribution. A propagandist needs a series of fake accounts on which to post, and others to boost it into the mainstream where it can go viral.”

Russia and China have a history of testing disinformation campaigns on smaller countries, according to Schneier. “Countering new disinformation campaigns requires being able to recognize them, and recognizing them requires looking for and cataloging them now,” he wrote.


Read more: AI disinformation is a threat to elections − learning to spot Russian, Chinese and Iranian meddling in other countries can help the US prepare for 2024


3. Healthy skepticism

But it doesn’t require the resources of shadowy intelligence services in powerful nations to make headlines, as the New Hampshire fake Biden robocall produced and disseminated by two individuals and aimed at dissuading some voters illustrates. That episode prompted the Federal Communications Commission to ban robocalls that use voices generated by artificial intelligence.

AI-powered disinformation campaigns are difficult to counter because they can be delivered over different channels, including robocalls, social media, email, text message and websites, which complicates the digital forensics of tracking down the sources of the disinformation, wrote Joan Donovan, a media and disinformation scholar at Boston University.

“In many ways, AI-enhanced disinformation such as the New Hampshire robocall poses the same problems as every other form of disinformation,” Donovan wrote. “People who use AI to disrupt elections are likely to do what they can to hide their tracks, which is why it’s necessary for the public to remain skeptical about claims that do not come from verified sources, such as local TV news or social media accounts of reputable news organizations.”


Read more: FCC bans robocalls using deepfake voice clones − but AI-generated disinformation still looms over elections


How to spot AI-generated images.

4. A new kind of political machine

AI-powered disinformation campaigns are also difficult to counter because they can include bots – automated social media accounts that pose as real people – and can include online interactions tailored to individuals, potentially over the course of an election and potentially with millions of people.

Harvard political scientist Archon Fung and legal scholar Lawrence Lessig described these capabilities and laid out a hypothetical scenario of national political campaigns wielding these powerful tools.

Attempts to block these machines could run afoul of the free speech protections of the First Amendment, according to Fung and Lessig. “One constitutionally safer, if smaller, step, already adopted in part by European internet regulators and in California, is to prohibit bots from passing themselves off as people,” they wrote. “For example, regulation might require that campaign messages come with disclaimers when the content they contain is generated by machines rather than humans.”


Read more: How AI could take over elections – and undermine democracy


This story is a roundup of articles from The Conversation’s archives.


This article is part of Disinformation 2024: a series examining the science, technology and politics of deception in elections.

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Disinformation is rampant on social media – a social psychologist explains the tactics used against you

Misinformation, disinformation and hoaxes: What’s the difference?

Disinformation campaigns are murky blends of truth, lies and sincere beliefs – lessons from the pandemic


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Artificial mucus identifies link to tumor formation

NEW ORLEANS, March 18, 2024 – During cold and flu season, excess mucus is a common, unpleasant symptom of illness, but the slippery substance is essential…

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NEW ORLEANS, March 18, 2024 – During cold and flu season, excess mucus is a common, unpleasant symptom of illness, but the slippery substance is essential to human health. To better understand its many roles, researchers synthesized the major component of mucus, the sugar-coated proteins called mucins, and discovered that changing the mucins of healthy cells to resemble those of cancer cells made healthy cells act more cancer-like.

Credit: American Chemical Society

NEW ORLEANS, March 18, 2024 – During cold and flu season, excess mucus is a common, unpleasant symptom of illness, but the slippery substance is essential to human health. To better understand its many roles, researchers synthesized the major component of mucus, the sugar-coated proteins called mucins, and discovered that changing the mucins of healthy cells to resemble those of cancer cells made healthy cells act more cancer-like.

The researcher will present her results today at the spring meeting of the American Chemical Society (ACS). ACS Spring 2024 is a hybrid meeting being held virtually and in person March 17-21; it features nearly 12,000 presentations on a range of science topics.

“For hundreds of years, mucus was considered a waste material or just a simple barrier,” says Jessica Kramer, a professor of biomedical engineering who led the study. And indeed, it does serve as a barrier, regulating the transport of small molecules and particulates to underlying epithelial cells that line the respiratory and digestive tracts. But it also does much more. Studies show that mucus and mucins are biologically active, playing roles in immunity, cell behavior and defense against pathogens and cancer. Kramer’s team at the University of Utah, for example, recently found that specific sugars attached to mucins inhibited coronavirus infection in cell culture.

“Part of the challenge of studying mucus and mucins in general is that they have quite a variety of protein structures,” Kramer explains. Although humans share more than 20 mucin genes, those genes are expressed differently in different tissues and are spliced to generate a range of proteins. In addition, cells modify those proteins in myriad ways with different sugars to meet the body’s needs.

Complicating the picture, genetic factors alone don’t determine mucin composition. Dietary and environmental factors can also influence which sugars become attached to these proteins. Thus, mucus composition can vary significantly from person to person, from day to day, and from tissue to tissue, all of which makes it difficult to identify the biological effects of any given mucin.

To study mucin properties, researchers can collect mucus from animals in slaughterhouses, Kramer says. “But ultimately, it’s quite labor intensive and difficult to purify. And in the process of doing the harvesting, usually the sticky, slimy properties are disrupted.”

As an alternative, mucins can be purchased off-the-shelf, Kramer explains. But because batch-to-batch variability can lead to problems with experimental reproducibility, methods are needed to reliably produce synthetic mucins at scale and at a reasonable price.

In the absence of a simple genetic method to produce individual mucins, Kramer’s lab combined synthetic chemistry and bacterial enzymes to generate the core polypeptides and then selectively add sugars to create unique synthetic mucins. This allows the researchers to test the physical, chemical and biological properties of individual types of mucin molecules and identify the impact of changing individual sugars or protein sequences.

Kramer, along with the lab of collaborator Jody Rosenblatt at King’s College London, is applying her team’s mucins to questions of cancer biology. In particular, the scientists are exploring the influence of mucins on the earliest stages of tumor formation. Previous studies in other labs have shown that mucins embedded in the surface of cancer cells promote metastasis, the spread of cancer to other tissues in the body. These mucins can also help the cancer cells evade immune system defenses by blocking immune cell activation.

“We are building synthetic mucins to understand how the chemical aspects of these proteins affect the behavior of cancer cells,” Kramer explains. “It hasn’t been possible to study these things before because we can’t control the molecular properties of mucins using traditional genetic and biochemical methods.”

Normally, as non-cancerous epithelial cells grow, they crowd together, with some getting eliminated from the epithelial layer to maintain a consistent and stable tissue structure. When Kramer’s team engineered the cells to have a bulky mucin-rich surface similar to that of cancer cells, the cells stopped extruding normally and piled up, forming what looked like the start of tumors.

Kramer is quick to note, however, that her team has not determined whether the genetics of the cells have changed, so they cannot yet state definitively whether the healthy cells were transformed into cancer cells. Those studies are ongoing.

The insights will be pivotal for the development of possible cancer treatments targeting mucins, as they will help highlight which parts of the mucin molecules are most important to tumor formation.

Scientists have been trying to make mucin-targeting therapeutics for decades, but that hasn’t worked well, in part because the sugar groups on the molecules weren’t fully taken into account, Kramer says. “For a vaccine, we can’t only consider the protein sequence because that’s not what the molecule looks like to the immune system. Instead, when an immune cell bumps into the surface of a cancer cell it’s going to see the sugars first, not the protein backbone.” So she believes an effective vaccine will need to target those mucin sugars.

Beyond cancer, the ability to reliably modify the protein sequence and sugars and produce scalable quantities of synthetic mucins offers opportunities to develop these molecules as anti-infectives, probiotics and therapies to support reproductive and women’s health, Kramer says.

The research was funded by the National Institute of General Medical Science, National Science Foundation and Marion Milligan Mason Fund.

Visit the ACS Spring 2024 program to learn more about this presentation, “Synthetic mucins: From new chemical routes to engineered cells,” and more scientific presentations. 

###

The American Chemical Society (ACS) is a nonprofit organization chartered by the U.S. Congress. ACS’ mission is to advance the broader chemistry enterprise and its practitioners for the benefit of Earth and all its people. The Society is a global leader in promoting excellence in science education and providing access to chemistry-related information and research through its multiple research solutions, peer-reviewed journals, scientific conferences, eBooks and weekly news periodical Chemical & Engineering News. ACS journals are among the most cited, most trusted and most read within the scientific literature; however, ACS itself does not conduct chemical research. As a leader in scientific information solutions, its CAS division partners with global innovators to accelerate breakthroughs by curating, connecting and analyzing the world’s scientific knowledge. ACS’ main offices are in Washington, D.C., and Columbus, Ohio.

To automatically receive news releases from the American Chemical Society, contact newsroom@acs.org.

Note to journalists: Please report that this research was presented at a meeting of the American Chemical Society. ACS does not conduct research, but publishes and publicizes peer-reviewed scientific studies.

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Title
Synthetic mucins: From new chemical routes to engineered cells

Abstract
Mucin glycoproteins are the major component of mucus and the epithelial glycocalyx. Mucins are essential for life, serving roles as a physical barrier, a lubricant, and a biochemical moderator of infection, immunity, and cancer. There are more than 20 known mucin genes with variable expression patterns, splicing, and post-translational glycosylation patterns. Such diversity has challenged study of structure-function relationships. We are developing scalable methods, based on polymerization of amino acid N-carboxyanhydrides, to synthesize glycan-bearing polypeptides that capture the chemical and physical properties of native mucins. We are utilizing these synthetic mucins to form fully synthetic mucus hydrogels and to engineer the glycocalyx of live cells to shed light on the role of glycans in health and disease. This talk will focus on advances in chemical synthesis along with application of synthetic mucins in study of tumorigenesis.


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Harvard Medical School Professor Was Fired Over Not Getting COVID Vaccine

Harvard Medical School Professor Was Fired Over Not Getting COVID Vaccine

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

A…

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Harvard Medical School Professor Was Fired Over Not Getting COVID Vaccine

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

A Harvard Medical School professor who refused to get a COVID-19 vaccine has been terminated, according to documents reviewed by The Epoch Times.

Martin Kulldorff, epidemiologist and statistician, at his home in Ashford, Conn., on Feb. 11, 2022. (Samira Bouaou/The Epoch Times)

Martin Kulldorff, an epidemiologist, was fired by Mass General Brigham in November 2021 over noncompliance with the hospital’s COVID-19 vaccine mandate after his requests for exemptions from the mandate were denied, according to one document. Mr. Kulldorff was also placed on leave by Harvard Medical School (HMS) because his appointment as professor of medicine there “depends upon” holding a position at the hospital, another document stated.

Mr. Kulldorff asked HMS in late 2023 how he could return to his position and was told he was being fired.

You would need to hold an eligible appointment with a Harvard-affiliated institution for your HMS academic appointment to continue,” Dr. Grace Huang, dean for faculty affairs, told the epidemiologist and biostatistician.

She said the lack of an appointment, combined with college rules that cap leaves of absence at two years, meant he was being terminated.

Mr. Kulldorff disclosed the firing for the first time this month.

“While I can’t comment on the specifics due to employment confidentiality protections that preclude us from doing so, I can confirm that his employment agreement was terminated November 10, 2021,” a spokesperson for Brigham and Women’s Hospital told The Epoch Times via email.

Mass General Brigham granted just 234 exemption requests out of 2,402 received, according to court filings in an ongoing case that alleges discrimination.

The hospital said previously, “We received a number of exemption requests, and each request was carefully considered by a knowledgeable team of reviewers.

A lot of other people received exemptions, but I did not,” Mr. Kulldorff told The Epoch Times.

Mr. Kulldorff was originally hired by HMS but switched departments in 2015 to work at the Department of Medicine at Brigham and Women’s Hospital, which is part of Mass General Brigham and affiliated with HMS.

Harvard Medical School has affiliation agreements with several Boston hospitals which it neither owns nor operationally controls,” an HMS spokesperson told The Epoch Times in an email. “Hospital-based faculty, such as Mr. Kulldorff, are employed by one of the affiliates, not by HMS, and require an active hospital appointment to maintain an academic appointment at Harvard Medical School.”

HMS confirmed that some faculty, who are tenured or on the tenure track, do not require hospital appointments.

Natural Immunity

Before the COVID-19 vaccines became available, Mr. Kulldorff contracted COVID-19. He was hospitalized but eventually recovered.

That gave him a form of protection known as natural immunity. According to a number of studies, including papers from the U.S. Centers for Disease Control and Prevention, natural immunity is better than the protection bestowed by vaccines.

Other studies have found that people with natural immunity face a higher risk of problems after vaccination.

Mr. Kulldorff expressed his concerns about receiving a vaccine in his request for a medical exemption, pointing out a lack of data for vaccinating people who suffer from the same issue he does.

I already had superior infection-acquired immunity; and it was risky to vaccinate me without proper efficacy and safety studies on patients with my type of immune deficiency,” Mr. Kulldorff wrote in an essay.

In his request for a religious exemption, he highlighted an Israel study that was among the first to compare protection after infection to protection after vaccination. Researchers found that the vaccinated had less protection than the naturally immune.

“Having had COVID disease, I have stronger longer lasting immunity than those vaccinated (Gazit et al). Lacking scientific rationale, vaccine mandates are religious dogma, and I request a religious exemption from COVID vaccination,” he wrote.

Both requests were denied.

Mr. Kulldorff is still unvaccinated.

“I had COVID. I had it badly. So I have infection-acquired immunity. So I don’t need the vaccine,” he told The Epoch Times.

Dissenting Voice

Mr. Kulldorff has been a prominent dissenting voice during the COVID-19 pandemic, countering messaging from the government and many doctors that the COVID-19 vaccines were needed, regardless of prior infection.

He spoke out in an op-ed in April 2021, for instance, against requiring people to provide proof of vaccination to attend shows, go to school, and visit restaurants.

The idea that everybody needs to be vaccinated is as scientifically baseless as the idea that nobody does. Covid vaccines are essential for older, high-risk people and their caretakers and advisable for many others. But those who’ve been infected are already immune,” he wrote at the time.

Mr. Kulldorff later co-authored the Great Barrington Declaration, which called for focused protection of people at high risk while removing restrictions for younger, healthy people.

Harsh restrictions such as school closures “will cause irreparable damage” if not lifted, the declaration stated.

The declaration drew criticism from Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, and Dr. Rochelle Walensky, who became the head of the CDC, among others.

In a competing document, Dr. Walensky and others said that “relying upon immunity from natural infections for COVID-19 is flawed” and that “uncontrolled transmission in younger people risks significant morbidity(3) and mortality across the whole population.”

“Those who are pushing these vaccine mandates and vaccine passports—vaccine fanatics, I would call them—to me they have done much more damage during this one year than the anti-vaxxers have done in two decades,” Mr. Kulldorff later said in an EpochTV interview. “I would even say that these vaccine fanatics, they are the biggest anti-vaxxers that we have right now. They’re doing so much more damage to vaccine confidence than anybody else.

Surveys indicate that people have less trust now in the CDC and other health institutions than before the pandemic, and data from the CDC and elsewhere show that fewer people are receiving the new COVID-19 vaccines and other shots.

Support

The disclosure that Mr. Kulldorff was fired drew criticism of Harvard and support for Mr. Kulldorff.

The termination “is a massive and incomprehensible injustice,” Dr. Aaron Kheriaty, an ethics expert who was fired from the University of California–Irvine School of Medicine for not getting a COVID-19 vaccine because he had natural immunity, said on X.

The academy is full of people who declined vaccines—mostly with dubious exemptions—and yet Harvard fires the one professor who happens to speak out against government policies.” Dr. Vinay Prasad, an epidemiologist at the University of California–San Francisco, wrote in a blog post. “It looks like Harvard has weaponized its policies and selectively enforces them.”

A petition to reinstate Mr. Kulldorff has garnered more than 1,800 signatures.

Some other doctors said the decision to let Mr. Kulldorff go was correct.

“Actions have consequence,” Dr. Alastair McAlpine, a Canadian doctor, wrote on X. He said Mr. Kulldorff had “publicly undermine[d] public health.”

Tyler Durden Sat, 03/16/2024 - 21:00

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