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‘Epic Waste of $500 Million’: Scientists Slam HHS Funding for ‘Next-Gen’ COVID Oral and Nasal Vaccine Trials

By John-Michael Dumais | The Defender | June 24, 2024

The U.S. Department of Health and Human Services (HHS) has announced up to $500 million in funding for clinical trials of three next-generation COVID-19 vaccine candidates, including two nasal sprays and an oral pill.

The initiative, part of the $5 billion Project NextGen, aims to develop innovative vaccines that are easier to administer and provide improved protection against the SARS-CoV-2 virus.

The funding, awarded through the Biomedical Advanced Research and Development Authority (BARDA) under HHS’ Administration for Strategic Preparedness and Response (ASPR), will support Phase 2b clinical trials for Vaxart‘s oral pill vaccine (up to $453 million) and CyanVac’s (up to $40 million) and Castlevax’s ($34 million) intranasal vaccines.

Each company’s phase 2b trials will recruit 10,000 volunteers to compare the safety and efficacy of the investigational vaccine against the existing mRNA vaccines.

ASPR Assistant Secretary Dawn O’Connell said in a news release that the new vaccines “may … be easier to administer through intranasal or oral delivery.” The announcement suggests the delivery methods have the “potential to improve vaccine access.”

However, the new delivery methods also raise unique concerns, especially the nasal vaccines, which use modified viruses as vectors.

Vaccine researcher Jessica Rose, Ph.D., told The Defender that she’s concerned about vaccine shedding and the possibility of pharmaceutical companies aerosolizing their products and administering them “without public knowledge as part of a ‘vaccination’ run.”

Brian Hooker, Ph.D., Children’s Health Defense chief scientific officer, echoed Rose’s concern about potential vaccine shedding, calling it a “nightmare like other live-virus vaccine formulations.”

Hooker told The Defender that because COVID-19 mutates rapidly, “immunity will still wane precipitously” for the new vaccine candidates, just as it did with the existing mRNA vaccines.

The new vaccines are “just more ‘me too’ technologies that are late to the party for COVID-19,” he said.

UGA spins off nasal vax biotech firm

University of Georgia (UGA) vaccine development spinoff CyanVac (an affiliate of Blue Lake Biotechnology) is set to begin phase 2b clinical trials for a new nasal COVID-19 vaccine, CVXGA. The study will be conducted through BARDA’s clinical studies network.

CyanVac founder Dr. Biao He, chair of veterinary medicine at UGA, leads the team behind CVXGA. He served on a White House panel in July 2022 advising on the future of COVID-19 vaccines, where he specifically promoted nasal vaccines.

CVXGA is a Parainfluenza virus 5 (PIV5)-based vaccine that encodes the spike protein of SARS-CoV-2.

Formally known as simian virus 5, PIV5 is often referred to as canine parainfluenza virus in the veterinary field, where it is a contributing factor to kennel cough in dogs. PIV5-based vaccines have been used to prevent kennel cough, reportedly without any safety concerns.

“PIV5 is a novel intranasal vaccine vector that has been shown to replicate safely in humans in clinical trials and stimulates all three pillars of immunity — cellular, mucosal, and humoral — with minimal uncomfortable side effects,” Dr. He said in the company’s press release.

Rose cautioned that some studies (here, here and here) have associated PIV5 with human diseases such as Creutzfeldt‐Jakob disease and multiple sclerosis, but noted that later research was unable to confirm PIV5 as the cause. “More research needs to be done before this is used as a viral vector in humans,” she said.

Currently, there are no licensed vaccines for humans that contain PIV5. However, besides the CVGXA COVID-19 vaccine, PIV5 is under development for vaccines targeting various human and animal infectious diseases, including Lyme disease, respiratory syncytial virus (RSV), influenza, rabies, tuberculosis and MERS-CoV.

Castlevax promises ‘game-changing’ spike protein vax

BARDA provided Castlevax, in collaboration with the Icahn School of Medicine at Mount Sinai in New York City, $34 million for its phase 2b trial of its intranasal vaccine candidate CVAX-01 beginning in Q4 2024.

The company is projected to receive as much as $338 million from BARDA for its COVID-19 “booster” vaccine.

Castlevax calls its vaccine “a next-generation COVID-19 vaccine with game-changing potential” with a design that “holds spike protein firmly in pre-fusion conformation, leading to more efficient induction of neutralizing antibodies.” It promises to “deliver reduced rates of breakthrough infections.”

Its vaccine, NDV-HXP-S, uses a recombinant Newcastle disease virus (NDV) that expresses the spike protein. The spike protein has been modified to contain six mutations by the HexaPro (HXP) technology developed at a University of Texas (UT), Austin laboratory.

HXP promises to make the spike protein more stable compared to older mRNA vaccines, which only contain two mutations. “Human antibodies recognize and respond to Hexapro better since the spike protein is less prone to shifting shapes,” according to a UT lab researcher.

The vaccine is grown in chicken eggs, a method commonly used to produce flu vaccines.

Castlevax boasts of having “multiple COVID-19 products in Phase 2 through Emergency Use Authorization, while we’re simultaneously developing a bivalent mucosal RSV+HMPV [human metapneumovirus] vaccine and a mucosal Norovirus vaccine.”

Promises and dangers of nasal vaccines

Hooker noted that nasal vaccines can be effective. “Mucosal immunity provides defenses at the mucous membrane level through a type of antibody called secretory IgA [immunoglobin A] along with humoral IgG and IgM antibodies,” he said.

But he cautioned that due to the observed rapid mutation in SARS-CoV-2 variants, “Long-term efficacy will be nil” for these vaccines.

Live virus nasal vaccines have been used for flu for years, he said, suggesting these latest entries are “looking for entry into the ‘annual’ COVID-19 vaccination market opportunity.”

Rose pointed out that EcoHealth Alliance’s 2018 DEFUSE proposal to the Defense Advanced Research Projects Agency (DARPA) included a plan to aerosolize bat vaccines and deliver them at the mouths of caves in China.

“They hired an aerosol tech company to find the best way to administer their products,” she said.

When she saw this part of the proposal, Rose speculated the technique could readily be used to vaccinate people without their consent. “Given that everything they’ve done so far has been from questionable to illegal, I really have to wonder.”

Hooker added that the three BARDA-funded projects use live-virus vaccines that are “notoriously bad for pregnant women.”

Oral pill targets epithelial cells

Vaxart will receive up to $453 million from BARDA to develop an oral pill vaccine, which is also just entering phase 2b clinical trials.

“Vaccine delivery has relied primarily on injection for more than 150 years,” said Steven Lo, Vaxart’s CEO in the press release. “This funding from BARDA will assist us in determining whether we can bring a transformational, next-generation approach to global vaccination.”

Vaxart’s pill, VXA-CoV2-1, uses an adenovirus vector to infect epithelial cells in the lower small intestine. The vaccine delivers the genetic material to create the spike protein. The company boasts that a special coating allows the oral pill to survive the low pH in the stomach.

Adenovirus vaccines reportedly cannot make you sick, and cannot replicate or be integrated into the host body’s DNA.

Johnson & Johnson’s (J&J) and AstraZeneca’s COVID-19 vaccines also used adenovirus vectors.

The use of J&J’s vaccine was paused in April 2021 due to reports of thrombosis with thrombocytopenia syndrome (TTS), a severe blood clotting disorder. In July 2021, the FDA warned about the risk of Guillain-Barré syndrome with the J&J vaccine after approximately 100 cases were reported among 12.8 million vaccine recipients. With existing doses of the J&J vaccine having expired in May 2023, the vaccine is no longer in use.

AstraZeneca’s COVID-19 vaccine also caused blood clots, resulting in temporary pauses in its use in several countries. With declining demand, it was also removed from the market in May 2023.

Trials set ‘a horribly low bar’

The two nasal and one oral vaccine candidates are all entering phase 2b trials where their safety and efficacy will be compared to the available FDA-approved mRNA vaccines.

Hooker said that this sets “a horribly low bar for comparison given that the ‘control’ group is now subjected to the vaccine that has the worst safety profile in history.”

He underscored that the mRNA vaccines offer “extremely limited and sometimes negative efficacy, and no utility in terms of prevention of transmission,” and argued that using them as comparators for the candidate vaccines would be next to useless.

“Basically, almost anything short of a vial of arsenic would perform comparably,” he said.

“Given the low morbidity/mortality of the currently circulating COVID-19 strains, this is an epic waste of $500 million,” he said. “Their ROI [return on investment] will essentially be a bunch of sick people with vaccine injuries.”

Rose said that long-term efficacy cannot be guaranteed “based on failure of maintained efficacy in COVID-19 product prototypes. This is precisely why they keep pushing ‘boosters.’”

Hooker also questioned the review and approval process for the new vaccines. He said:

“As far as independence, safeguards and transparency, those are now gone. Not because of this particular clinical trial entry, but because of the shamfest that FDA was and still is with the EUA [emergency use authorization] and approvals granted during the plandemic.

“All the tricks that they (Dr. Peter Marks and company) pulled like trying to prevent the release of clinical trial documents, approving without human trials, the joke that is CICP [Countermeasures Injury Compensation Program], etc., really spell death for any integrity in the approvals process.”

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This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

June 28, 2024 - Posted by aletho | Deception, Science and Pseudo-Science | COVID-19 Vaccine, United States