This weekend, while speaking at the Liberty Forum of Silicon Valley, I was asked a question about the status of the development of an influenza/COVID-19 mRNA vaccine.
A quick search on clinicaltrials.gov (which is a government website where clinical trials are registered), found the following combined influenza/COVID-19 clinical trial, which is currently recruiting:
This is a phase 1 and 2 combined randomized clinical trial which anticipates enrollment of 1,050 participants.
Today, a reader sent me a link to the article below, which clearly shows that the pre-clinical phase of these combination vaccines has been concluded and APPROVED by the FDA. Enrollment for the clinical trials is about to begin.
Based on COVID-19 ‘messenger’ RNA or mRNA vaccines, the new flu vaccines could better protect people from multiple types of flu. First up for testing: older people.
- Moderna has created a new vaccine that aims to provide combined protection against both flu and COVID-19, including the most recent variants of COVID-19
- (The clinical trial director) expects to start testing Moderna’s combined flu/COVID-19 vaccine in the late summer or early fall.
Colorado (UC Health) already has an “mRNA vaccine for influenza” clinical trial that is already enrolling, and this one is about about to enroll. What does this mean?
- This means that these mRNA combo vaccines are again being given status as a “vaccine,” and not a gene therapy product. Otherwise, pre-clinical development would have taken much, much longer.
- That the use of pseudouridine has been given the green light again, without further preclinical testing on safety. That the length of time the mRNA continues to make protein once in the body and levels of protein expressed over time has not been assessed in an animal body prior to the onset of these trials. This is shocking.
- It appears that the FDA also did not require more testing of the nano lipid particles for safety, reproductive toxicity and bio-distribution in an animal model. This assumption is again based on the short timeline to clinical trial for these products.
- This also implies that there have been no further pre-clinical studies regarding the spike protein as a toxin in the combination flu/COVID-19 mRNA vaccine candidate.
With this doozy of truth bomb, I set out to discover just what clinical trials are currently enrolling
A couple of simple searches on ClinicalTrials.gov revealed that there are a large number of new trials currently enrolling or about to enroll. In fact, the simple search term “mRNA vaccine” had a search result of 98 clinical trials not yet recruiting and currently enrolling. Of those currently enrolling, clinicaltrials.gov had a chart for those results, as follows.
So, what are these clinical trials? The government website provides a list of 81 clinical trials using the search term mRNA vaccines which are actively enrolling participants is linked here.
These include clinical trials for COVID-19, influenza (alone and in combination with COVID-19 mRNA vaccines), HIV, leukemia, RSV, Pneumococcal, EBV, HPV, CMV, Zika, Metapneumovirus and Human Parainfluenza Infection. These clinical trials also include safety studies on vulnerable populations and children.
As these clinical trials are up and running, that means that they have already passed preclinical testing. I think we can assume that a lot of the “normal” requirements for pre-clinical testing of a vaccine or gene therapy product have been bypassed, due to the expedited time to enroll patients. This means that most likely issues with the pseudouridine creating immunosuppression, the issues with this synthetic mRNA that neither breaks down easily in the body and also continues to produce protein for an extended period or time, the effects of repeating pseudouridine in the mRNA strands -which may have significant impacts on cellular metabolism and properties- have not been assessed. Furthermore, the use of pseudouridine as an immuno-modulator has not been addressed Then there are the issues with the nano lipid particle distribution and associated toxicity, including reproductive safety and crossing of the blood-brain barrier. Then there is the fact that these are gene therapy procedures, not traditional protein or polysaccharide-based vaccines. Furthermore, for the new COVID-19 combo products, the spike protein is being produced by the mRNA – meaning the toxicity of this protein still has not been assessed in a preclinical trial!
Because we know from the Pfizer data package that inherent safety issues with these vaccines were swept under the rug under the EUA authorization, and that these issues should have been red flags for other mRNA vaccine clinical trials, it is hard to believe that any of these issues were addressed. Particularly since many of the fundamental issues with these vaccines have only recently been discovered, and that the adverse events and papers exposing the dangers only keep growing. The FDA has normalized these vaccines with the Emergency Use Authorization that then appears to have allowed at least some of these products to move forward rapidly.