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On the Horizon, Needle-Free Vaccines could Offer Better Protection and Access

In the near future, painful jabs and muscle soreness that persists for days could be replaced by new immunization approaches including intradermal delivery,…



On the horizon, needle-free vaccines could offer better protection and access

Published: Oct 25, 2022

By Gail Dutton


Everyone is tired of being jabbed, but today, that’s the predominant option for vaccination. In the near future, however, the painful jab and muscle soreness that persists for days will be eliminated by needleless vaccines that – at least in some cases – provide more robust protection.

They also hold could eliminate the need for temperature-controlled storage and some of the accompanying medical infrastructure, helping to lower costs. These combined attributes make it easier to vaccinate populations in the developing world and to vaccinate children and adults who fear needles or are simply weary of getting shots.

Intradermal Delivery

“Improving the delivery system is another way to increase effectiveness of the vaccine,” said Chris Cappello, president and CEO of PharmaJet in an interview with BioSpace.

PharmaJet’s jet injection system is ready now. “We push the vaccine or the drug, which is a fluid, through a small aperture that controls the stream of vaccine, (constricting it into) a fine column about the size of one or two human hairs,” Capello said. “It penetrates the body in about one-tenth of a second.”

Importantly, the system can be tailored to deliver the vaccine or drug into the skin or into the muscle.

“We’re finding the skin is one of the best places to elicit immune responses,” Capello said. Intradermal injections, for instance, can use one-fifth the DNA dose used by intramuscular injection, yet elicit higher humoral and cellular responses.

This delivery method can be used for nucleic acid-based vaccines, where “we’re seeing stronger T cells and antibody responses,” he said, in addition to more traditional formulations. Although the exact responses vary by vaccine, “at a minimum, we’re showing non-inferiority, and in other instances, we’re seeing double or triple improvements in effectiveness.”

PharmaJet has more than 60 clinical and pharmaceutical partners and 80 clinical studies underway. The company just received a $1.5 million grant from USAID to evaluate needle-free injection for polio immunizations. It is also working with the World Health Organization for intradermal delivery of a polio vaccine, and the U.S. Defense Threat Reduction Agency to deliver a Venezuelan equine encephalitis DNA vaccine.

PharmaJet also recently began a licensure study on an mRNA vaccine for COVID-19 vaccine in India.

“The technology is commercialized,” he said. Now, “We’re focusing in areas where we can enable greater access to life-improving pharmaceuticals. There’s a shift toward intradermal delivery, and we want to be the global leader in that.”

Edible Vaccines

Edible vaccines are one of multiple options in development, and one of the most challenging due to the risk of degradation in the gut. Corn, rice, bananas, tomatoes, potatoes, lettuce, soybeans and even wheat have each been considered by various research groups. Regulatory approval, however, remains elusive.

Lumen Bioscience is engineering spirulina, a blue-green algae considered a superfood, to produce therapeutic proteins as an oral booster after a primary vaccination by other means.

Brian Finrow_Lumen Bioscience“The recent paper in Nature NPJ Vaccines reflects success with an intranasal prime and an oral boost,” said Brian Finrow, J.D., CEO and co-founder of Lumen. As an initial vaccine, however, intranasal administration is more effective.

The research was conducted in collaboration with the University of Washington.   

Lumen has clinical programs in Clostridioides difficile colitis, COVID-19 and traveler’s diarrhea, and preclinical programs in malaria, IBD and metabolic disease.

“Most of those are passive vaccines, in which you make the antibodies and fill the GI tract with them for a disease like C. difficile, rather than active vaccines like our malaria program,” Finrow said.

The company’s malaria vaccine recently achieved durable, sterile immunity in mice, and the NIH just funded the second phase of the program, taking it into non-human primates.

A benefit to using spirulina is its ease of production and breadth of applicability. Spirulina can be engineered to deliver protein biologics, including hormones, antibodies or cytokines, and can be produced using sterile vat fermentation. Taking it from the vat to finished product is mainly a matter of drying the spirulina biomass, performing a clarifying lysate to remove the cellular debris and then turning it into a dry powder. 

Consequently, Jim Roberts, M.D., Ph.D., co-founder and CSO, told BioSpace, “It’s remarkably inexpensive to make…just pennies per dose.” Lumen’s 20,000 liter cGMP production capacity “is very easily scalable to address large commercial markets,” he said.

“We can manufacture enormous quantities of pretty much any kind of biologic molecule or protein therapeutic we care to make,” Finrow added. “We want to make so much of the (antibody or protein) that is pervasively available not just in the rich world, but in the very distributed areas of sub-Saharan Africa, Southeast Asia, etc.”

While Lumen did start its program with an edible vaccine, “The best option is to make an upper-airway inhalable vaccine to elicit a mucosal immune response,” Roberts continued.

With this approach, Lumen’s recombinant protein vaccine for malaria elicits not only a strong mucosal response but “the systemic immune response is as strong as the immune response you get by injecting the malaria parasite itself.” Whether that is true for all vaccines remains to be seen.

Intranasal Vaccines

Blue Water Vaccines is planning Phase I trials with its live attenuated intranasal vaccine, BWV-201, for acute otitis media (AOM) – middle ear infections and strep pneumonia.

“AOM is caused predominantly by strep pneumonia,” said Joseph Hernandez, chairman and CEO. “That causes morbidity and, long term, antibiotic resistance.”

The early work on an AOM vaccine was performed by researchers at St. Jude’s Children’s Hospital, and then in-licensed by Blue Water.

Needle-free delivery is important, Hernandez said, because, “Kids get vaccinated a lot, so introducing another vaccine that has a needle component to it isn’t exactly attractive. The other aspect is biological.

“We first encounter strep pneumonia in the nasal cavity. Because of that, mucosal immunity is very important because that immunity is different from cell-mediated immunity, which is what occurs after an intramuscular injection.”

Biologically, therefore, it makes sense to deliver a respiratory disease vaccine intranasally, where the virus is first encountered.

So far, Blue Water has conducted animal studies in mice and chinchilla (which behave very similarly to humans with middle ear infections).

“The data shows, consistently and predictably, that we can create a mucosal immune response to the bacteria and further, that it inhibits the ability for these bacteria to colonize the middle ear. More importantly, it reduces the cause of middle early infections in these animal models. Now we have to test that in humans.”

Recently, Blue Water released data around pneumonia infections in the lung, showing the ability of its vaccine to prevent polymerization of bacteria there.

“We saw some great signals,” Hernandez said. A clinical trial looking at middle ear infections in the pediatric population and lung pneumonia for a broader pediatric and adult population is being planned for 2023.

Currently, the vaccine is delivered as a liquid aerosolized form, although Blue Water is considering ways to preserve it longer, possibly through lyophilization.

These are just a few of the companies advancing needleless vaccine delivery systems. Routine use, however, remains on the near horizon. For this season’s influenza and COVID-19 boosters, most of us can still expect a jab.

Source: BioSpace

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Looking Back At COVID’s Authoritarian Regimes

After having moved from Canada to the United States, partly to be wealthier and partly to be freer (those two are connected, by the way), I was shocked,…



After having moved from Canada to the United States, partly to be wealthier and partly to be freer (those two are connected, by the way), I was shocked, in March 2020, when President Trump and most US governors imposed heavy restrictions on people’s freedom. The purpose, said Trump and his COVID-19 advisers, was to “flatten the curve”: shut down people’s mobility for two weeks so that hospitals could catch up with the expected demand from COVID patients. In her book Silent Invasion, Dr. Deborah Birx, the coordinator of the White House Coronavirus Task Force, admitted that she was scrambling during those two weeks to come up with a reason to extend the lockdowns for much longer. As she put it, “I didn’t have the numbers in front of me yet to make the case for extending it longer, but I had two weeks to get them.” In short, she chose the goal and then tried to find the data to justify the goal. This, by the way, was from someone who, along with her task force colleague Dr. Anthony Fauci, kept talking about the importance of the scientific method. By the end of April 2020, the term “flatten the curve” had all but disappeared from public discussion.

Now that we are four years past that awful time, it makes sense to look back and see whether those heavy restrictions on the lives of people of all ages made sense. I’ll save you the suspense. They didn’t. The damage to the economy was huge. Remember that “the economy” is not a term used to describe a big machine; it’s a shorthand for the trillions of interactions among hundreds of millions of people. The lockdowns and the subsequent federal spending ballooned the budget deficit and consequent federal debt. The effect on children’s learning, not just in school but outside of school, was huge. These effects will be with us for a long time. It’s not as if there wasn’t another way to go. The people who came up with the idea of lockdowns did so on the basis of abstract models that had not been tested. They ignored a model of human behavior, which I’ll call Hayekian, that is tested every day.

These are the opening two paragraphs of my latest Defining Ideas article, “Looking Back at COVID’s Authoritarian Regimes,” Defining Ideas, March 14, 2024.

Another excerpt:

That wasn’t the only uncertainty. My daughter Karen lived in San Francisco and made her living teaching Pilates. San Francisco mayor London Breed shut down all the gyms, and so there went my daughter’s business. (The good news was that she quickly got online and shifted many of her clients to virtual Pilates. But that’s another story.) We tried to see her every six weeks or so, whether that meant our driving up to San Fran or her driving down to Monterey. But were we allowed to drive to see her? In that first month and a half, we simply didn’t know.

Read the whole thing, which is longer than usual.


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Problems After COVID-19 Vaccination More Prevalent Among Naturally Immune: Study

Problems After COVID-19 Vaccination More Prevalent Among Naturally Immune: Study

Authored by Zachary Stieber via The Epoch Times (emphasis…



Problems After COVID-19 Vaccination More Prevalent Among Naturally Immune: Study

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

People who recovered from COVID-19 and received a COVID-19 shot were more likely to suffer adverse reactions, researchers in Europe are reporting.

A medical worker administers a dose of the Pfizer-BioNTech COVID-19 vaccine to a patient at a vaccination center in Ancenis-Saint-Gereon, France, on Nov. 17, 2021. (Stephane Mahe//Reuters)

Participants in the study were more likely to experience an adverse reaction after vaccination regardless of the type of shot, with one exception, the researchers found.

Across all vaccine brands, people with prior COVID-19 were 2.6 times as likely after dose one to suffer an adverse reaction, according to the new study. Such people are commonly known as having a type of protection known as natural immunity after recovery.

People with previous COVID-19 were also 1.25 times as likely after dose 2 to experience an adverse reaction.

The findings held true across all vaccine types following dose one.

Of the female participants who received the Pfizer-BioNTech vaccine, for instance, 82 percent who had COVID-19 previously experienced an adverse reaction after their first dose, compared to 59 percent of females who did not have prior COVID-19.

The only exception to the trend was among males who received a second AstraZeneca dose. The percentage of males who suffered an adverse reaction was higher, 33 percent to 24 percent, among those without a COVID-19 history.

Participants who had a prior SARS-CoV-2 infection (confirmed with a positive test) experienced at least one adverse reaction more often after the 1st dose compared to participants who did not have prior COVID-19. This pattern was observed in both men and women and across vaccine brands,” Florence van Hunsel, an epidemiologist with the Netherlands Pharmacovigilance Centre Lareb, and her co-authors wrote.

There were only slightly higher odds of the naturally immune suffering an adverse reaction following receipt of a Pfizer or Moderna booster, the researchers also found.

The researchers performed what’s known as a cohort event monitoring study, following 29,387 participants as they received at least one dose of a COVID-19 vaccine. The participants live in a European country such as Belgium, France, or Slovakia.

Overall, three-quarters of the participants reported at least one adverse reaction, although some were minor such as injection site pain.

Adverse reactions described as serious were reported by 0.24 percent of people who received a first or second dose and 0.26 percent for people who received a booster. Different examples of serious reactions were not listed in the study.

Participants were only specifically asked to record a range of minor adverse reactions (ADRs). They could provide details of other reactions in free text form.

“The unsolicited events were manually assessed and coded, and the seriousness was classified based on international criteria,” researchers said.

The free text answers were not provided by researchers in the paper.

The authors note, ‘In this manuscript, the focus was not on serious ADRs and adverse events of special interest.’” Yet, in their highlights section they state, “The percentage of serious ADRs in the study is low for 1st and 2nd vaccination and booster.”

Dr. Joel Wallskog, co-chair of the group React19, which advocates for people who were injured by vaccines, told The Epoch Times: “It is intellectually dishonest to set out to study minor adverse events after COVID-19 vaccination then make conclusions about the frequency of serious adverse events. They also fail to provide the free text data.” He added that the paper showed “yet another study that is in my opinion, deficient by design.”

Ms. Hunsel did not respond to a request for comment.

She and other researchers listed limitations in the paper, including how they did not provide data broken down by country.

The paper was published by the journal Vaccine on March 6.

The study was funded by the European Medicines Agency and the Dutch government.

No authors declared conflicts of interest.

Some previous papers have also found that people with prior COVID-19 infection had more adverse events following COVID-19 vaccination, including a 2021 paper from French researchers. A U.S. study identified prior COVID-19 as a predictor of the severity of side effects.

Some other studies have determined COVID-19 vaccines confer little or no benefit to people with a history of infection, including those who had received a primary series.

The U.S. Centers for Disease Control and Prevention still recommends people who recovered from COVID-19 receive a COVID-19 vaccine, although a number of other health authorities have stopped recommending the shot for people who have prior COVID-19.

Another New Study

In another new paper, South Korean researchers outlined how they found people were more likely to report certain adverse reactions after COVID-19 vaccination than after receipt of another vaccine.

The reporting of myocarditis, a form of heart inflammation, or pericarditis, a related condition, was nearly 20 times as high among children as the reporting odds following receipt of all other vaccines, the researchers found.

The reporting odds were also much higher for multisystem inflammatory syndrome or Kawasaki disease among adolescent COVID-19 recipients.

Researchers analyzed reports made to VigiBase, which is run by the World Health Organization.

Based on our results, close monitoring for these rare but serious inflammatory reactions after COVID-19 vaccination among adolescents until definitive causal relationship can be established,” the researchers wrote.

The study was published by the Journal of Korean Medical Science in its March edition.

Limitations include VigiBase receiving reports of problems, with some reports going unconfirmed.

Funding came from the South Korean government. One author reported receiving grants from pharmaceutical companies, including Pfizer.

Tyler Durden Fri, 03/15/2024 - 05:00

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‘Excess Mortality Skyrocketed’: Tucker Carlson and Dr. Pierre Kory Unpack ‘Criminal’ COVID Response

‘Excess Mortality Skyrocketed’: Tucker Carlson and Dr. Pierre Kory Unpack ‘Criminal’ COVID Response

As the global pandemic unfolded, government-funded…



'Excess Mortality Skyrocketed': Tucker Carlson and Dr. Pierre Kory Unpack 'Criminal' COVID Response

As the global pandemic unfolded, government-funded experimental vaccines were hastily developed for a virus which primarily killed the old and fat (and those with other obvious comorbidities), and an aggressive, global campaign to coerce billions into injecting them ensued.

Then there were the lockdowns - with some countries (New Zealand, for example) building internment camps for those who tested positive for Covid-19, and others such as China welding entire apartment buildings shut to trap people inside.

It was an egregious and unnecessary response to a virus that, while highly virulent, was survivable by the vast majority of the general population.

Oh, and the vaccines, which governments are still pushing, didn't work as advertised to the point where health officials changed the definition of "vaccine" multiple times.

Tucker Carlson recently sat down with Dr. Pierre Kory, a critical care specialist and vocal critic of vaccines. The two had a wide-ranging discussion, which included vaccine safety and efficacy, excess mortality, demographic impacts of the virus, big pharma, and the professional price Kory has paid for speaking out.

Keep reading below, or if you have roughly 50 minutes, watch it in its entirety for free on X:

"Do we have any real sense of what the cost, the physical cost to the country and world has been of those vaccines?" Carlson asked, kicking off the interview.

"I do think we have some understanding of the cost. I mean, I think, you know, you're aware of the work of of Ed Dowd, who's put together a team and looked, analytically at a lot of the epidemiologic data," Kory replied. "I mean, time with that vaccination rollout is when all of the numbers started going sideways, the excess mortality started to skyrocket."

When asked "what kind of death toll are we looking at?", Kory responded " 2023 alone, in the first nine months, we had what's called an excess mortality of 158,000 Americans," adding "But this is in 2023. I mean, we've  had Omicron now for two years, which is a mild variant. Not that many go to the hospital."

'Safe and Effective'

Tucker also asked Kory why the people who claimed the vaccine were "safe and effective" aren't being held criminally liable for abetting the "killing of all these Americans," to which Kory replied: "It’s my kind of belief, looking back, that [safe and effective] was a predetermined conclusion. There was no data to support that, but it was agreed upon that it would be presented as safe and effective."

Carlson and Kory then discussed the different segments of the population that experienced vaccine side effects, with Kory noting an "explosion in dying in the youngest and healthiest sectors of society," adding "And why did the employed fare far worse than those that weren't? And this particularly white collar, white collar, more than gray collar, more than blue collar."

Kory also said that Big Pharma is 'terrified' of Vitamin D because it "threatens the disease model." As journalist The Vigilant Fox notes on X, "Vitamin D showed about a 60% effectiveness against the incidence of COVID-19 in randomized control trials," and "showed about 40-50% effectiveness in reducing the incidence of COVID-19 in observational studies."

Professional costs

Kory - while risking professional suicide by speaking out, has undoubtedly helped save countless lives by advocating for alternate treatments such as Ivermectin.

Kory shared his own experiences of job loss and censorship, highlighting the challenges of advocating for a more nuanced understanding of vaccine safety in an environment often resistant to dissenting voices.

"I wrote a book called The War on Ivermectin and the the genesis of that book," he said, adding "Not only is my expertise on Ivermectin and my vast clinical experience, but and I tell the story before, but I got an email, during this journey from a guy named William B Grant, who's a professor out in California, and he wrote to me this email just one day, my life was going totally sideways because our protocols focused on Ivermectin. I was using a lot in my practice, as were tens of thousands of doctors around the world, to really good benefits. And I was getting attacked, hit jobs in the media, and he wrote me this email on and he said, Dear Dr. Kory, what they're doing to Ivermectin, they've been doing to vitamin D for decades..."

"And it's got five tactics. And these are the five tactics that all industries employ when science emerges, that's inconvenient to their interests. And so I'm just going to give you an example. Ivermectin science was extremely inconvenient to the interests of the pharmaceutical industrial complex. I mean, it threatened the vaccine campaign. It threatened vaccine hesitancy, which was public enemy number one. We know that, that everything, all the propaganda censorship was literally going after something called vaccine hesitancy."

Money makes the world go 'round

Carlson then hit on perhaps the most devious aspect of the relationship between drug companies and the medical establishment, and how special interests completely taint science to the point where public distrust of institutions has spiked in recent years.

"I think all of it starts at the level the medical journals," said Kory. "Because once you have something established in the medical journals as a, let's say, a proven fact or a generally accepted consensus, consensus comes out of the journals."

"I have dozens of rejection letters from investigators around the world who did good trials on ivermectin, tried to publish it. No thank you, no thank you, no thank you. And then the ones that do get in all purportedly prove that ivermectin didn't work," Kory continued.

"So and then when you look at the ones that actually got in and this is where like probably my biggest estrangement and why I don't recognize science and don't trust it anymore, is the trials that flew to publication in the top journals in the world were so brazenly manipulated and corrupted in the design and conduct in, many of us wrote about it. But they flew to publication, and then every time they were published, you saw these huge PR campaigns in the media. New York Times, Boston Globe, L.A. times, ivermectin doesn't work. Latest high quality, rigorous study says. I'm sitting here in my office watching these lies just ripple throughout the media sphere based on fraudulent studies published in the top journals. And that's that's that has changed. Now that's why I say I'm estranged and I don't know what to trust anymore."

Vaccine Injuries

Carlson asked Kory about his clinical experience with vaccine injuries.

"So how this is how I divide, this is just kind of my perception of vaccine injury is that when I use the term vaccine injury, I'm usually referring to what I call a single organ problem, like pericarditis, myocarditis, stroke, something like that. An autoimmune disease," he replied.

"What I specialize in my practice, is I treat patients with what we call a long Covid long vaxx. It's the same disease, just different triggers, right? One is triggered by Covid, the other one is triggered by the spike protein from the vaccine. Much more common is long vax. The only real differences between the two conditions is that the vaccinated are, on average, sicker and more disabled than the long Covids, with some pretty prominent exceptions to that."

Watch the entire interview above, and you can support Tucker Carlson's endeavors by joining the Tucker Carlson Network here...

Tyler Durden Thu, 03/14/2024 - 16:20

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