Part way through an extraordinary discussion with the owlish but energetic professor and historic biotech entrepreneur, Professor Thomas Rademacher, Co-Founder and CEO of Emergex Vaccines, a vaccine-creating and manufacturing organization based in the U.K., he matter-of-factly interjects, “We’re leaving mRNA vaccines in the dust and moving onto a different approach to vaccines.”
That ‘dust-generating’ science and technology is a proprietary T cell-based platform.
“The only vaccines that have ever been successful for RNA viruses, which include the world's nastiest, so Chikungunya, Zika, flu, HIV, Ebola, are the live attenuated vaccines. Think yellow fever, measles, mumps, and polio vaccines,” says Rademacher.
“But then the whole world went a little bit crazy with the mRNA vaccines to fight SARS-CoV-2, which creates an antibody response. The point about antibody-based vaccines is the viruses are never outside the cell."
COVID, he points out, moves from cell A to cell B to cell C. It lives entirely inside of cells. It spends its entire life inside cells.
Therefore, in general, until COVID came along, scientists looked to develop cellular-based vaccines – a cellular immune response that will kill the infected cell.
A T cell system, for example, “never even looks at the virus," says Rademacher. "It couldn't care less about the virus. But it quickly recognizes that a cell is infected.”
“It’s basic immunology,” he adds. “In natural infection and immunity, as soon as the cell is infected it can be recognized for cell death – often within less than 30 or 40 seconds. It's that fast.”
So what’s going on here? Two years past the worst of the epidemic, are we now open to some uncensored opinion?
Clarifying Some Points
Although many think we initially take in a huge cloud of viruses, according to Rademacher normally humans become infected with “a single one of these creatures.” This initial stage is called the bottleneck, and this "one-virus theory" was successfully measured for COVID.
Only this single virus is needed to get inside a cell to create the building blocks it requires to replicate. At that point, we have some 20 hours before the virus can get those building blocks in working order.
"Unfortunately, you don't have our T cell army there yet," Rademacher says. That doesn’t appear until about day six. It takes the immune system about a week to "generate an army that's going to kill these infected cells.”
In the interim, we must depend on our innate immune system (e.g., natural killer cells, interferons). The innate immune system attempts to keep things at bay until our T cell system kicks in. And that's when we begin to feel sick.
“And to be clear: There is no role for an antibody in that at all,” declares Rademacher, with a light laugh no doubt hiding a dose of frustration. With SARS-CoV-2, he says, "the infection is gone before any antibodies would even appear anyway. You have to kill the cell before it makes any variants."
Basic immunology, then, suggests we need our T cell army there to kill the infected cells before the virus can replicate and spread to neighboring healthy cells.
“That's what happens in you almost every day. You're being re-exposed to things all the time, but your T cell army has been created. That's how yellow fever vaccine works. Your pre-made T cell army is at the ready. It's the only way you can really create what's called an abortive infection, and stop transmission. That's immunology 101. It's been known for 30 years.”
Known, but challenged by implementation: How do you effectively raise that army pre-infection?
“How do you turn on T cells which will sit around and wait to kill an infected cell? That’s what we are doing,” says Rademacher. “I believe that's what any immunologist would say we should be doing.”
Time To Be Heard?
Emergex currently has two clinical candidates generated from its T cell vaccine platform, one for Dengue and one, in fact, targeting COVID.
The company is privately held and headquartered in Abingdon, Oxfordshire, UK. It has R&D facilities in Milton Park, UK, an operating subsidiary in Doylestown, Pennsylvania, and a GMP capable manufacturing facility in Fremont, California (more on this facility here).
The company’s first objective is to development a range of “100% synthetic CD8+ T cell-priming immune set-point candidates” to harness the body’s natural cellular immune response and destroy pathogen-infected cells, and provide immune protection against some of the world’s most urgent infectious diseases.
Rademacher has been researching such initiatives for some 40+ years; as documented earlier, he’s a historic figure in our biotech industry. He believes today the industry is on the cusp of developing T cell vaccines that are "scientifically, clinically, and field-data proven."
He does not believe that has been the case with the recent mRNA vaccines, and he is disheartened the industry went in the direction of mRNA vaccines for COVID.
In fact, he says, “as more data comes in, there are some concerning issues that need to be challenged.”
He notes it appears none of the big vaccine producers are actually pursuing new iterations of mRNA vaccines for SARS-CoV-2 (other than, I’d add, a savvy objective of developing a vaccine that is combined with the annual flu shot).
Rademacher informs me that three years ago, he and other like-minded vaccine specialists had numerous meetings with U.K-government and other health officials to raise concerns about the emerging vaccines, but little if nothing came of these.
“Today, I am concerned about all these excess deaths and adverse reactions that are now being documented, especially in young men. Therefore, it is our primary mission to move towards developing a more effective vaccine for COVID, specifically a T cell-based vaccine.”
Perhaps this makes it official: At least for COVID, it's now a battle between mRNA and T Cell vaccines.