• June 4, 2023

RNA Vaccine Clinical Trials

Ongoing and Completed (excluding COVID-19) and what you can do.

As I have written about before, clinicaltrials.gov is a government website, mandated by Congress. Per Clinical Trials Registration and Results Information Submission (final rule) of the Federal Registrar:

This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov…

Under section 402(j) of the PHS Act, those responsible for specified clinical trials of these FDA-regulated products have been required to submit registration information to ClinicalTrials.gov since December 26, 2007, summary results information for clinical trials of approved products as of September 27, 2008, and certain adverse events information since September 27, 2009.

Basically, all clinical trials from the moment they are registered with the US government, until they are completed or withdrawn, must summit information at each stage to clinicaltrials.gov, which then places all that data on a public web site, which is searchable by disease, key words, etc.

The clinicaltrial.gov search engine has been in use since 2007, it has undergone very little change. There appears to have been a modest effort made to make it more user friendly. A boolean search engine has been standard for the Internet since its inception. I remember learning about them as an undergraduate in the early 1980s. There is no boolean search engine on clinicaltrials.gov. Using clinicaltrials.gov to determine the mRNA and RNA vaccine clinical trial landscape is an exercise in frustration management, as one must literally go through and exclude results in order to make an accurate assessment.

Below is what are the search results for new vaccine products likely to be on the market and also, which, if any have the likelihood of being mandated and/or placed on the childhood vaccine schedule.

There are 13 completed mRNA vaccine trials that involve disease targets other than COVID-19. These clinical trials are for rabies (EU, Curevac), influenza (USA, Pfizer), metastatic non-small cell lung cancer (Germany, Curevac, Medimmune and others), pneumococcal infection (USA, Merck), hormonal refractory prostate cancer (Germany, Curevac), seasonal influenza ( 2 completed CTs – Moderna), Zika virus (USA Moderna, BARDA), Cytomegalovirus Infection (2 completed CTs – USA, Moderna), Metapneumovirus and Parainfluenza infection (USA, Moderna), advanced malignant melanoma (Oslo), prostate cancer (Oslo).

Note that the pneumococcal conjugate vaccine is given to all babies and young children and is on the CDC childhood vaccine schedule. So that fact that Merck has completed a psuedo mRNA vaccine clinical trial on pneumococcal vaccines is of great interest.

A basic search of “mRNA vaccine” with the search terms recruiting and/or ongoing clinical trials and then excluding COVID-19 vaccines resulted in approximately 51 results (my hand count could be slightly off).

These clinical trials (with their sponsors listed) are for the following diseases:

HIV (International AIDS Vaccine Initiative with Moderna), seasonal influenza, RSV, Cytomegalovirus (Moderna), Nipah Virus Infection (NIAD, Moderna), influenza (3 CTs – Sanofi Pasteur, a Sanofi Company), ovarian cancer (University Medical Center Groningen and BioNTech SE), HIV (International AIDS Vaccine Initiative, Moderna and others), shingles (Pfizer), influenza (2 CTs – Pfizer), Epstein-Barr virus-related refractory malignant tumors (West China Hospital), hepatocellular carcinoma (West China Hospital), posto perative hepatocellular carcinoma (Shanghai Zhongshan Hospital), lymphocytic leukemia (Bnai Zion Medical Center), esophageal cancer and non small cell lung cancer (Stemirna Therapeutics), personalized mRNA tumor vaccine (Changhai Hospital), non-small cell lung cancer (Curevac, pharmajet, Ludwig Institute for Cancer Research, others), RSV (Moderna), Lymphocytic Leukemia (NCI, City of Hope Hosp), influenza (Curevac), RSV (Sanofi), RSV (Moderna), carcinoma, squamous Cell – head and neck neoplasm – cervical neoplasm – penile neoplasms malignant (BioNTech SE, Univ of SouthHampton), influenza (Pfizer), Tuberculosis (2 clinical trials – BioNTech SE), Malaria (BioNTech SE), seasonal influenza (Moderna), influenza (Curevac, GSK), Genital Herpes (BioNTech SE), head and neck cancers (BioNTech SE), combined RSV and flu (Pfizer), Melanoma (2 CTs – BioNTech SE), Cytomegalovirus (Moderna), Zika (Moderna), Hematologic Malignancies – solid tumors (NCI), Melanoma (Moderna), CMV (4 CTs – Moderna), combined SARS-CoV-2, Influenza and RSV (Moderna), seasonal influenza (Moderna), EBV (Moderna), influenza (Sanofi Pasteur), Papillomavirus Infections + COVID-19 (Merck), influenza (Moderna), Herpes Zoster (Moderna), RSV (Moderna).

A search on the word phrase RNA vaccine resulted in 3001 results and using their new beta search engine 3700+ results. Self-amplifying RNA vaccines, RNA-lipid Particle (RNA-LP) Vaccines, RNA vaccines, RNA-based vaccines are some of the RNA vaccine keywords that I found in these search results. But not all of these results are for RNA vaccines – as the words RNA and vaccines could be in the keywords individually but not related to RNA vaccines. These results include COVID-19 vaccines, as doing a search to exclude this term was too time intensive, as I would have had to scroll through all the results and catalog all of the vaccines listed as either non COVID-19 or COVID-19 related.

Because the search engine is not boolean, it does not allow for excluding keywords or for and/or searches. So unless I literally went through the 3000+ results, I can not easily determine if clinical trials are being conducted for other childhood infectious diseases that on the schedule. Nonetheless, we know that Human papillomavirus (HPV), pneumococcal disease, RSV, influenza, and herpes zoster are disease targets for the mRNA vaccines listed above. These are all diseases associated with childhood that are either on the CDC vaccine schedule for children or in the case of RSV, on their wish list to be.

As I wrote about last year, there was a World Health Organization (WHO) consultation in April, 2021 whereby US government officials laid out strategies for the process of future mRNA vaccine approvals by the FDA.

Dr Keith Peden (Center for Biologics Evaluation and Research (CBER), Food and Drug Administration presented the FDA’s experience and position on licensure of new mRNA vaccine products.

Dr Keith Peden (Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), USA) presented the FDA’s experience with mRNA vaccines, including product and Chemistry, Manufacturing and Controls (CMC) issues, potency determination, pre-clinical studies, efficacy assessment (what to monitor and what assays to use), evaluation of possible vaccine-enhanced disease, and the question of whether or not mRNA can be viewed as a platform technology. He commented that whether the individual LNP component should be evaluated separately or as the vaccine is an individual NRA’s decision. CBER decided only the product should be tested…

CBER has determined that this is in flux, and has not required that biodistribution studies be performed on a new vaccine if studies with another vaccine using the same manufacturing process and same LNP have already been done.

For those that may have missed my Substack on this “informal consultation” and what it means for pseudo-mRNA vaccine candidates:

CBER decided that going forward, with new mRNA vaccine trials, ONLY the product (the final formulation) should be tested as long as same manufacturing process and LNP are used. This is despite the fact that CBER did not do complete biodistribution or toxicity studies on these products, as discovered in the FOIA Japanese pre-clinical package and the US court ordered document release.

Essentially, CBER has completely bypassed the issues of these vaccines not having a complete pre-clinical evaluation, and in April 2021 decided that new mRNA vaccines in development will not have to comply with the norms for vaccine development…

CBER has determined that bio-distribution studies on new mRNA vaccines using this “platform technology” will not have to be redone, even though they were not properly evaluated in the first place. This is over the top idiocy. New products will be allowed to proceed with human testing without having a complete pre-clincial data package – as what was submitted to the FDA was cobbled together from previous studies is incomplete. For instance, a reporter gene (luciferase) instead of the spike protein was used for toxicity and bio-distribution studies, and the LEAST sensitive assay to detect protein expression was used in the studies. As a consequence, the biodistribution data which the FDA is relying on is a gross underestimate of the true bio-distribution of transgene protein expression. The bio-distribution studies were done using techniques that were not able to differentiate bio-distribution in tissues. Instead, whole animal imaging was used, which is essentially a parlor trick, and is absolutely not quantitative. Good for pictures on the cover of Rolling Stone, but not for actual bio-distribution analysis. This was the specific problem which I called Dr. Peter Marks about last fall, and which he assured me had been addressed in the full data package submitted by Pfizer. Just for the record, he lied to me.

What this all means is that using these flawed pre-clinical trials to support a platform technology was PLANNED from the beginning. By not focussing on the payload of the vaccines, but instead relying on the generic formulations prior to initiating clinical trials, this has allowed CBER (as well as Moderna, and Pfizer/BioNTech) to transfer these highly flawed pre-clinical data packages to all upcoming mRNA vaccine trials for new vaccine products!

The implications of this are enormous. First, it is complete regulatory failure as well as yet more evidence of regulatory capture. Second, that this “pandemic” has been exploited to drive approval of a mRNA platform technology -whereby only TWO companies will be allowed to compete (those that completed the two approved pre-clinical packages).

We know now that the pseudouridine-containing mRNA does not break down for months. But rather, it stays in the body producing protein. This is not natural mRNA by any stretch of the imagination, and it does not behave like natural mRNA. This technology, as currently practiced by Moderna and Pfizer/BioNTech, employs a novel polymeric biomolecule, the properties of which have not been well characterized. The protein levels being produced by these vaccines is not known, the duration of protein production isn’t known, and the biodistribution of protein production is not known. And the FDA and other global regulatory authorities are all comfortable with this?? As an example of one of the dangers with not knowing the protein levels, distribution and duration of transgene expression, we know from many prior immune tolerance studies that too much antigen (protein in this case), can cause “tolerance.” That is essentially where the immune system stops seeing the threat. These vaccines could easily drive up tolerance against a virus. We know from multiple peer reviewed papers from top global laboratories that they are driving “immune imprinting” or “original antigenic sin” problems- in human beings (not just mice). This is not theoretical. It is real, and being exacerbated by the “booster vaccines” (FDA terminology) or “new vaccines” (US White House terminology).

In the future, as companies will have to face an onslaught of new requirements, such as addressing the stability of the mRNA in these vaccines, it will be almost impossible to now move away from this manufacturing process and LNP. This will become the platform technology because of the shortsighted position taken by the FDA/CBER.

Another issue is that this synthetic mRNA (pseudouridine was substituted for uridine) is that it is immunosuppressive. Having this mRNA in the body suppresses not only the ability to fight off latent DNA viruses such as shingles, EBV, CMV and even cancer, it is likely to also suppress the ability of the immune system to detect cancer.

And here we are. It feels like there isn’t much that can be done, but actually through the use of grass roots organizations, protests, fifth-gen warfare tactics, the message is getting through to the public. Politicians are noticing. Now is the time we have to double down on the fight to stop these unsafe products from making their way through the system.

What people can do:

  1. Write your Congressperson or Senator, demand an investigation (feel free to reference this Substack or my earlier one on this topic, as well as the document approved by the World Health Organization, titled “WHO informal consultation on regulatory considerations for evaluation of the quality, safety and efficacy of RNA-based prophylactic vaccines for infectious diseases, 20–22 April 2021” document.
  2. Do not inject yourself and try hard to convince your family and friends not to be injected with a “pseudo-mRNA vaccine.”
  3. Go back to fifth-gen warfare tactics. Share and retweet memes, cartoons, music and articles on social media that accurately assess the dangers and risks of “pseudo-mRNA vaccines.” Wear T-shirts – let your local community know how you feel.
  4. Use terms that accurately describe these products. Try to avoid the use of the word “vaccine.”
  5. Write letters and offer testimony to the CDC, ACIP meetings and the FDA when the option is available.
  6. Share and crosspost -this essay and other essays like it. Feel free to republish (just please credit Robert W. Malone, MD as the author) and cite the subtack.
  7. Some of the most successful campaigns against this technology has come from the state groups or organizations like the Unity project, Texas Vaccines for Choice and many, many others. Find your local group, join and volunteer.
  8. Recognize that what has happened over the past three years has been the rise of a totalitarian state – both at the national and international level. The “fight” is bigger” than these injections. Public health has been weaponized. fifth-gen warfare tactics are working. The WHO has backed down to some extent. This is because of public outcry and the public continuing to present the risks.
  9. Speak at your local school board, give public testimony at your state senate or congress about the safety risks, lack of complete clinical trials and everything we all know about these pseudo-mRNA vaccines.

    Who is Robert Malone is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

    Thank you for reading Who is Robert Malone. This post is public so feel free to share it.


    Leave a comment


Subscribe to Who is Robert Malone

By Robert W Malone MD  ·  Over 299,000 subscribers

Medicine, science, bioethics, analytics, politics and life

Share on:
Freedom vs Tyranny

Editor @Investigator_50