Sprayable COVID Vaccine Trial Raises âSignificant Safety Concernsâ
Several scientists and researchers questioned the design of the trial for the CVXGA1 nasal vaccine, suggesting the trial did not examine âif shed materials can be spread to others.â The trial also included just 72 participants and lacked an unvaccinated control group.
A sprayable intranasal mRNA COVID-19 vaccine demonstrated effectiveness in its Phase 1 clinical trial, according to a study published last week in the journal Science Advances.
However, critics questioned the trialâs design and limited sample size. And some suggested that the sprayable vaccine â CVXGA1, produced by CyanVac LLC â could pose a risk to the public.
Investigative journalist Sonia Elijah noted that CVXGA1, which enters the mucus membranes and lungs through the nose, has the âpotential for shedding viral particles through intranasal secretions, which could expose unvaccinated individuals.â
Elijah said the study didnât examine if shed materials can be spread to others. âThis raises significant safety concerns about replication and shedding risks,â she said.
Karl Jablonowski, Ph.D., senior research scientist for Childrenâs Health Defense, said the platform CVXGA1 uses as a vector is parainfluenza virus type 5, a âcommunicable respiratory virus between humans and non-human animals that is evading our immune system.â
Jablonowski said this platform exacerbates the risk of shedding. âSince it is self-spreading, there is no informed consent or medical precautions as the âvaccineâ may infect infants, children, pregnant women, immunocompromised or medically frail.â
Karina Acevedo Whitehouse, Ph.D., professor of microbiology at the Autonomous University of QuerĂŠtaro in Mexico, agreed. Citing studies involving similar vaccines, Whitehouse said there are âhigh chancesâ this vaccine will result in âpersistent shedding.â
Whitehouse cited a 2023 study of an intranasal RSV (respiratory syncytial virus) vaccine, which detected virus shedding in 17% of participants.
CVXGA1 produces the SARS-CoV-2 virus spike protein â which was also contained in the mRNA COVID-19 vaccines produced by Pfizer and Moderna.
Medical experts and peer-reviewed studies have suggested the spike protein poses potentially serious risks to human health.
âGenetically modifying an infectious respiratory virus to express a spike protein is a familiar and really bad idea,â Jablonowski said. âThe immune system will be antagonized by the presence of the spike protein.â
Clinical trial flawed, experts say
According to the CVXGA1 Phase 1 study, CVXGA1 âis a potentially effective intranasal COVID-19 vaccineâ that produces an immune response with minimal adverse reactions.
The clinical trial included just 72 participants, ages 12-53, split into two groups. One group received a âhigh doseâ of the vaccine, the other received a smaller dose.
Findings showed the high-dose group demonstrated âSignificantly lower rates of symptomatic COVID-19 infectionâ and that the vaccine was âwell tolerated without serious adverse events (AEs) or fever reported.â
However, several scientists and researchers noted that the trial lacked an unvaccinated control group.
âThere is absolutely no way that this paper can be considered evidence that this intranasal gene-therapy based product is safe or effective,â Whitehouse said. âNo group was used as a control with which to compare the results ⌠as well as adverse events. This in itself invalidates any interpretation of safety and effectiveness of this product.â
According to Elijah, the lack of a control group and the small sample size âweakens the trialâs ability to accurately assess safety and immunogenicity,â but these arenât the only flaws.
Elijah said:
âThe study lacks data on RNA detection levels and did not perform infectivity assays to confirm if shed materials can be spread to others.
âThe lack of specific safety and immunogenicity data for the adolescent group raises concerns about the vaccineâs effects in younger individuals.
âThe open-label design, where both participants and researchers knew who received the vaccine, introduces potential bias in reporting and assessing outcomes, such as adverse events.â
Whitehouse noted that the studyâs researchers claimed they didnât identify any serious adverse events. However, they tracked adverse events only âduring a limited time frame,â which âreduces the chances of detecting serious events that may occur after this time period.â
Researchers plan to enroll 10,000 participants for the next phase of the clinical trial.
According to immunologist and biochemist Jessica Rose, Ph.D., if clinical trials for CVXGA1 are deemed a success, âthis could be used to push gene-based (mRNA, RNA and DNA) products on us via intranasal (breathing) routes.â
Clinical trial site previously hosted Pfizer COVID vaccine trials for adolescents
Experts also noted that the clinical trials were not performed independently but were fully funded by CyanVac.
According to the studyâs disclosure statement, several of the researchers are CyanVac employees or equity holders, are under contract with the company, or have received research grants from other pharmaceutical companies, including COVID-19 vaccine manufacturers AstraZeneca, Moderna and Pfizer.
Investors such as Bill Gates have previously shown interest in inhalable and sprayable vaccines, although it is unclear whether Gates is involved with the development of CVXGA1.
Elijah noted that Cincinnati Childrenâs Hospital ran the trial and Dr. Paul Spearman, the hospitalâs vice chair of clinical and translational research and education, led it. The hospital was one of the sites for adolescent clinical trials of Pfizerâs COVID-19 vaccine.
In 2021, a participant in one of those trials, 12-year-old Maddie de Garay, was severely injured after she received the second dose of the Pfizer vaccine. She sustained several serious adverse events and ended up in a wheelchair.
According to Elijah, doctors at the hospital dismissed any connection between de Garayâs injuries and the Pfizer vaccine, and instead classified her injuries as âneuralgia and functional abdominal pain.â
from:Â https://childrenshealthdefense.org/defender/sprayable-covid-vaccine-trial-raises-safety-concerns/



