Prepping for ‘Disease X’: Gates-Backed Group Funds Needle-Free mRNA Vaccine ‘Wafer’ Technology
With funding from the Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations is investing $1.2 million in a startup to create under-the-tongue vaccine wafers that can be stored at any temperature. Critics question the reliability of the technology and the safety of the mRNA platform.
The Coalition for Epidemic Preparedness Innovations (CEPI) is partnering with Jurata Thin Film Inc. to develop a wafer-like mRNA film that can be stored at room temperature and taken under the tongue for needle-free vaccine delivery.
The partnership will begin with a $1.2 million investment to help Jurata develop its proprietary vaccine platform, which the company says stabilizes mRNA-containing lipid nanoparticle vaccine technologies in a thin film.
Jurata claims the film is designed to be “thermostable,” produced and stored at room temperature and remain stable for three years, eliminating the need for energy-intensive cold storage required by current mRNA vaccines.
The film can be placed inside the cheek or under the tongue to deliver the vaccine. It can also be rehydrated with an aqueous solution and taken nasally or through other means that don’t require passage through the digestive tract.
Jurata and CEPI tout the technology as key to getting vaccines to poor people across the world. “If shown to be successful,” CEPI said in its press release, the technology will “help expand access to mRNA vaccines in underserved regions and advance the global response to future emerging infectious disease outbreaks.”
However, scientists who spoke to The Defender said that “success” seemed unlikely anytime soon. They also said the technology could pose problems even beyond the serious known risks with existing mRNA transfection technology.
Brian Hooker, Ph.D., senior director of science and research at Children’s Health Defense (CHD), said:
“Vaccines require cold storage (mostly refrigeration) and mRNA vaccines are especially susceptible to heat damage during shipping and storage. A thermostable platform completely eliminates the need for refrigeration and would be a huge breakthrough in getting rid of ‘cold chain requirements’ in delivering vaccines to the developing world and would also constitute a big cost savings in deployment overall.
“But outside of the other obvious issues with mRNA vaccines, I would be worried that the mRNA wouldn’t be as thermostable as purported and this would induce sequence mutations and other damage to the genetic code.”
Jurata is a small biotech firm developing the films for vaccine delivery and other therapeutics. Its founders also founded Bamboo Therapeutics, a gene therapy biotech company acquired in 2016 by Pfizer in a deal valued at $827 million.
Jurata is the fifth partner announced as part of CEPI’s January 2022 call for proposals for thermostable vaccine manufacturing innovations. The company said more announcements are on the horizon.
Recently, organizations including the World Health Organization (WHO), Gavi, the Vaccine Alliance and the Bill & Melinda Gates Foundation, among others, have touted the potential benefits of non-needle vaccine delivery technologies including microarray patches, pens and now microfilms as “groundbreaking,” “game changers” and “the future of vaccination.”
They claim these technologies have the potential to make vaccines accessible to remote areas, particularly in the Global South, where infrastructure for the cold storage necessary for vaccines is lacking, especially for mRNA vaccines which require ultra-cold temperatures of -20 degrees Celsius to -80 C.
They also say these technologies can “help promote vaccine uptake in areas of vaccine hesitancy” and reduce the need for providers by making it possible for people to self-administer vaccines.
Under the terms of the agreement with CEPI, Jurata committed to ensuring vaccine supply for the Global South by producing a volume of vaccines “required to meet public health needs,” setting affordable prices for Global South countries and potentially transferring the technology to Global South manufacturers.
Thermostable needle-free technologies are being widely promoted even though few clinical trials on any of these technologies have been completed and no such vaccine has yet been approved by regulators.
CHD Staff Scientist J. Jay Couey, Ph.D., told The Defender he thought the hype around such technologies is a “red herring” meant to make the public think any problems with these vaccines are technical questions of storage or delivery method — rather than the much more serious threat posed by mRNA transfection technologies themselves.
Despite all the boosterism around new vaccine delivery methods, the first-ever clinical trial of vaccine patches in children for the measles-rubella vaccine tested in Gambia was only shared in May by Micron Biomedical during the Microneedles 2023 conference in Seattle.
The Phase 1/2 trial delivered “promising” results, although to date the trial results have not been published in a peer-reviewed publication.
Despite the limited research, the Gates Foundation in November gave Micron Biomedical $23.6 million to fund the first mass production of needle-free vaccine technology. The Centers for Disease Control and Prevention also partnered with Micron.
CEPI says it hopes to use its funding to drive the development of such vaccines.
“We’re really looking to see a step change in the way that some of these vaccines can be stored and delivered,” said Ingrid Kromann, CEPI’s acting director of Vaccine Manufacturing and Supply Chain in a press release on the funding opportunity.
Of the $17.5 million CEPI is dedicating to thermostable vaccine development, it has already awarded $2 million to Tiba Biotech for its RNA nanoparticle delivery platform and $4.3 million to Vaxxas for pre-clinical trials on a microarray patch, $3.6 million to Gennova Biopharmaceuticals for a self-amplifying mRNA platform and $1.6 million to AvaxziPen — a needle-free platform to deliver solid-dose vaccine formulations via a pen applicator.
In the case of Jurata’s microfilm, the CEPI funding will support pre-clinical trials.
Given that mRNA technology became “one of the technological ‘shining stars’ during the COVID-19 pandemic,” Kromman said, thermostable vaccines with easy delivery like Jurata’s will be key to “advancing CEPI’s pandemic preparedness plan to accelerate the speed and scale of our response to future epidemics and pandemics, and heighten access to vaccine doses.”
‘Yet another controligarch-backed initiative’
CEPI describes itself as “an innovative global partnership between public, private, philanthropic and civil society organisations” launched at the World Economic Forum (WEF) in Davos in 2017, “to shorten the response time to epidemics by creating vaccines that could be released quickly once an outbreak occurs.”
The Gates Foundation co-founded CEPI with a $460 million investment. The Wellcome Trust and the WEF also are funders. CEPI CEO, Dr. Richard J. Hatchett, previously was acting director of the U.S. Biomedical Advanced Research and Development Authority.
Explaining why he founded CEPI, Bill Gates said:
“Unfortunately, even though there is substantial risk for epidemics, there is not a natural market for vaccines. You have to get governments to create the right incentive structure. If you can predict what the pathogens are going to be and can get vaccines stockpiled, then that would be a very good response.”
Gates Foundation employees hold both voting and non-voting positions on CEPI’s board, as do WHO employees.
“CEPI is yet another ‘Controligarch’-backed initiative that seeks to undermine national sovereignty and individual autonomy under the guise of philanthropy and saving lives,” Seamus Bruner, author of “Controligarchs: Exposing the Billionaire Class, their Secret Deals, and the Globalist Plot to Dominate Your Life,” told The Defender.
“They do this by leveraging crises — real and manufactured — to transfer decision making away from elected representatives to so-called experts and supranational organizations like the World Health Organization which are funded and controlled by an unelected — and therefore unaccountable — elite,” Bruner said.
The current funding is part of CEPI’s $3.5 billion pandemic preparedness plan, launched in March 2021 to develop technologies to ramp up the speed and scale of vaccine development for emerging pandemics so vaccine development times can be compressed to 100 days.
Vaccines have historically taken 10-15 years to develop. The mRNA COVID-19 vaccines were developed under Operation Warp Speed in less than a year.
The number of adverse events reported in the Vaccine Adverse Event Reporting System (VAERS) from the COVID-19 vaccines alone has been unprecedented in vaccine history, with 1,872,034 events reported as of Nov. 24.
Researchers from Correlation Research in the Public Interest estimate the vaccines are causally linked to approximately 17 million deaths worldwide.
CEPI’s mission under its preparedness plan is to fund the development of “rapid response platforms to develop vaccines against ‘Disease X’” — the WHO’s placeholder name for a disease that is currently unknown or not in existence, but that has the potential to be devastating for humanity.
The specter of Disease X was part of the rationale for the World Health Assembly to increase the WHO’s budget by 20% in June.
CEPI argues “the faster an effective vaccine is developed and deployed, the faster a potential pandemic threat can be contained and controlled if it is used.”
“The endless regimen of drugs and gene therapies that CEPI is working on — delivered via injections and other mechanisms — may end up being voluntary. But if Controligarchs like CEPI’s primary individual benefactor Bill Gates have their way, they will be mandatory,” Bruner said.
