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Scientists 'shocked' And 'alarmed' At What's In The MRNA Shots

Link: https://www.Spectator.Com.Au/2023/09/scientists-shocked-and-alarmed-at-whats-in-the-mrna-shots/

In particular, McKernan was alarmed to find the presence of an SV40 promoter in the Pfizer vaccine vials.Early in 2023, genomics scientist Kevin McKernan made an accidental discovery. While running an experiment in his Boston lab, McKernan used some vials of mRNA Pfizer and Moderna Covid vaccines as controls. He was "shocked" to find that they were allegedly contaminated with tiny fragments of plasmid DNA. McKernan, who has 25 years of experience in his field, ran the experiment again, confirming that the vials contained up to, in his opinion, 18-70 times more DNA contamination than the legal limits allowed by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). In particular, McKernan was alarmed to find the presence of an SV40 promoter in the Pfizer vaccine vials. This is a sequence that is "...Used to drive DNA into the nucleus, especially in gene therapies," McKernan explains. This is something that regulatory agencies around the world have specifically said is not possible with the mRNA vaccines.

■ Dr. Peter McCullough: COVID Vaccines Promote Cancer & Inhibit The Body's Ability To Fight Cancer! + VIDEO (09/02/23)

Europe Drawing Up Years-long MRNA COVID Vaccines Tender

The European Commission is drawing up plans for a tender for mRNA COVID-19 vaccines, according to people close to the discussions — but it's unclear if doses will be secured in time for this winter.

Several countries have confirmed to POLITICO that a tender for the joint procurement of COVID-19 mRNA vaccines is being discussed. This contract would run from 2023 through 2026 and would be the first joint procurement of COVID-19 vaccines outside of the pandemic.

As a new cold season emerges — and new adapted vaccines stand ready to begin shipments — some countries want to ensure they have sufficient supplies and choice of vaccines to protect their populations. Case numbers are once again picking up, including in hospital intensive care units.

While previous COVID-19 vaccine joint procurement agreements were awarded on a company by company basis, POLITICO understands that this tender would allow multiple companies to secure the same contract.

Currently, Pfizer/BioNTech is the only mRNA vaccine maker still to hold a valid contract. But the Commission's controversial decision to lock in 1.1 billion doses of their jab effectively excluded other players from the market, a situation made worse after the deal was renegotiated to spread deliveries into 2027.

That deal has been a source of controversy, both for its size, and for Commission President Ursula von der Leyen's personal role in negotiating it, with an alleged exchange of text messages between her and Pfizer CEO Albert Bourla.

Now, the Health Emergency Response and Preparedness Authority (HERA) is reaching out to countries to gauge their interest in buying more mRNA vaccines for their populations.

"We are assessing the needs and interests of the Member States for additional COVID-19 vaccines and should there be the required minimum four Member States interested, the Commission stands ready to launch the procedure," a spokesperson at the European Commission told POLITICO.

Norway and the Netherlands confirmed to POLITICO the Commission is planning joint procurement of mRNA vaccines through a tender. According to people close to the project, who were granted anonymity to speak about confidential discussions, up to eight countries have given their support and a further two have expressed an interest.

The Commission did not confirm that any joint procurement talks had begun. However the spokesperson said that HERA "would be leading on such a tendering process," and that the joint procurement agreement (JPA) "would be the tool used."

"HERA approached Norway and asked if Norway was interested in joining a joint procurement process [for mRNA vaccines]," said Knut Jønsrud, head of the vaccine supply unit at the Norwegian Institute of Public Health, who added that Norway has confirmed its interest in joining the agreement.

Both Pfizer/BioNTech and Moderna have updated their vaccines to the most recent dominant strainChristof Stache/AFP via Getty Images

A spokesperson at the Netherlands' health ministry confirmed that "options are being explored to purchase mRNA vaccines through a tendering procedure."

With supplies of the Pfizer/BioNTech mRNA vaccine secured until 2027, it's not clear whether these companies will bid in the tender, although it would be open to them. POLITICO contacted Pfizer for comment, but did not receive a reply before publication.

That leaves the door open to Moderna, which supplies the only other approved mRNA vaccine for COVID-19. Both Pfizer/BioNTech and Moderna have updated their vaccines to the most recent dominant strain.

Diversifying vaccine portfolios

Earlier this month, CEO Stéphane Bancel, said that adding Moderna's new XBB.1.5-targeted vaccine to immunization programs would "ensure a diversified portfolio that provides vaccine choice and access to single dose vial formats, which can limit waste." Moderna's previous EU contract expired in early 2023.

On Thursday, Emer Cooke, head of the European Medicines Agency, reiterated the need for countries to have a diverse portfolio of COVID-19 vaccines. This "really gives the opportunities for health care systems to choose what works best in their own environment," she said. That includes a "range of different vaccines — mRNA, protein-based — that provide the European population with the greatest choice and options that we can," she added.

Experts have called out the need to ensure supply chain resiliency through multiple vaccine manufacturers.

Novavax has a protein-based COVID-19 vaccine and is expecting an EU decision on its XBB.1.5 updated shot the week of October 9. The vaccine will be available to EU countries through its existing EU contract but this will expire by the end of the year, a spokesperson told POLITICO.

The European Commission, HERA and the countries have not confirmed if further COVID-19 vaccine tendering processes are in the works.

How Inverse Vaccines Might Tackle Diseases Like Multiple Sclerosis

This article first appeared in The Checkup, MIT Technology Review's weekly biotech newsletter. To receive it in your inbox every Thursday, and read articles like this first, sign up here.

I've written about vaccines for years, but recently I stumbled across a concept I had never heard of before. Typical vaccines prime the immune system to respond. But scientists are also working on "inverse vaccines" that teach the immune system to stand down.

Last week Jeffrey Hubbell and his colleagues at the University of Chicago reported that an inverse vaccine they developed had successfully reversed a disease similar to multiple sclerosis in mice. Hubbell has tested this approach before, but only as a way of preventing the disease—not curing it. "What is so exciting about this work is that we have shown that we can treat diseases like multiple sclerosis after there is already ongoing inflammation, which is more useful in a real-world context," he said in a press release.

These immune-dampening shots could lead to a whole host of therapies to treat autoimmune diseases. In fact, Anokion, a company Hubbell cofounded, has already launched clinical trials to test whether this type of inverse vaccine might help people with multiple sclerosis and celiac disease. It's an exciting prospect, so for The Checkup this week, let's take a look at inverse vaccines.

How do these vaccines work? Let's start with a little immunology 101. We tend to think of our immune system as a beefy bodyguard, fighting off pathogens that seek to harm us. But it has another, equally important job. "Mostly our immune system ignores stuff that it's being exposed to all the time," says Megan Levings at the BC Children's Hospital Research Institute in Vancouver (and a member of Anokion's scientific advisory board). That includes "all the food we eat, all the bacteria that live on our bodies, all the funguses and mold in the environment."

The capacity to ignore—known as immune tolerance—isn't passive. The immune system learns which things are dangerous and which are not, and stores that memory in specialized cells. When the system makes a mistake and flags a harmless protein as dangerous, the mixup can cause serious problems—allergies, autoimmune diseases, and other types of immune disorders.

With traditional vaccines, the goal is to deliver a foreign substance in a way that raises alarms. That's why vaccines are often combined with ingredients called adjuvants, which provoke a stronger immune response. (mRNA vaccines don't need adjuvants because the immune system already sees genetic material as a threat.) With inverse vaccines, also called tolerogenic vaccines because they provoke tolerance, the goal is to train the immune system to recognize that a particular target is harmless.

I should point out that the idea of tolerogenic vaccines is not new. Researchers have been working on them for decades, trying different methods for delivering the desired vaccine targets—called antigens—without provoking an immune response. But until now they've had little success.

Hubbell's group has developed a technique that involves adding a sugar to the antigen, which ensures that it travels to the liver. Why the liver? The organ has the ability to tag molecules with "harmless" labels. "It's actually harnessing normal biology," Levings says. (For a deeper dive into the paper, read Eric Topol's newsletter, Ground Truths. That's where I learned about the concept of inverse vaccines.)

But adding a sugar isn't the only way to develop an inverse vaccine. In 2021, a team from BioNTech and the Johannes Gutenberg University reported that they had developed a tolerogenic mRNA vaccine able to curb symptoms in several mouse models of multiple sclerosis. That's especially impressive given that mRNA tends to be so very good at prompting an immune response. The researchers achieved this by altering the fatty nanoparticle that carries the mRNA, but the exact mechanism wasn't totally clear even to Levings, who wrote a commentary on the paper.

Taking these therapies from bench to bedside won't be easy. It's tricky for a few different reasons, says Lawrence Steinman, a neuroimmunologist at Stanford University. First, with a complex disease such as multiple sclerosis, no single antigen is wholly responsible. So do you pick one, or "do you want to make a complex mixture of many of those antigens?" Steinman asks.

There's also the challenge of proving that the vaccine works. The treatments for many autoimmune diseases have gotten much better over the years. About 15 years ago, Steinman led a clinical trial to test a tolerogenic DNA vaccine in patients with multiple sclerosis. The vaccine worked, but not better than cutting-edge therapies. "We had a modest beneficial effect in reducing inflammation in the brain. But it could not compete with some of the drugs that were just coming on the market," he says. Now Steinman serves as chairman for a company called Pasithea Therapeutics, and he's working on a new inverse DNA vaccine for multiple sclerosis. This one will target a protein in the brain that mimics a portion of the Epstein-Barr virus, which may be a trigger for MS.

Safety is another concern, especially the risk that these vaccines could provoke an immune response rather than dampening it, which would make the disease worse. It's something that kept Steinman up at night when he was involved in that earlier trial.

If researchers can get these vaccines to work, the payoff could be enormous. Many people with autoimmune issues take immunosuppressive drugs that dampen the entire immune system, making them more vulnerable to infections and cancer. But a vaccine that tamps down the immune response to a specific antigen wouldn't have that effect. "It's a field where a lot of people want to make the breakthrough and become the next chapter in the glorious history of vaccination," Steinman says.

Another thing

Google DeepMind has developed AI to predict genetic variations likely to cause disease—technology that could eventually lead to faster diagnosis of rare conditions. Antonio Regalado has the story.

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