Moderna Promises New Omicron Variant Vaccine. Can They Just Do That Without New Trials?
US Federal Regulations Require Safety Testing of Proteins in New Vaccines. They Didn't Even do That with The First One, and Now We Have Vaccine Failure Less Than a Year Later.
Moderna has just announced that they will have a vaccine “ready” for the Omicron variant early next year. So what does that mean? Will they be able to start shipping it for distribution and use? Or will they be required by FDA to conduct studies - back to square one?
Under US Federal Regulations, vaccine manufacturers are required to demonstrate that the proteinaceous component of their vaccines are safe before they are used in humans. Oddly, they are not required to test excipients - ingredients like mercury, aluminum, polyethylene glycol… for safety, leading to an utter mess of confusion over whether these ingredients are safe.
Moderna’s website claims that they are already studying a bivalent vaccine that targets the extinct (my term, not theirs) and more recent variant. But then they represent their new planned Omicron vaccine as a “booster” of their old vaccine.
By definition, however, Moderna’s new vaccine will encode a new protein, untested in humans for safety, and is therefore a new vaccine, not a “booster”.
There is a litany of questions that FDA should require before the vaccine is mass-produced and shipped around for clinical use. These include:
(1) Pathogenic Priming - Which and how many of the epitopes (immunogenic peptide sequences) in the Omicron variant spike protein are unsafe epitopes as defined by research studies on autoreactogenicity of SARS-CoV-2 peptides?
(2) Disease Enhancement - Immunopathology - What are the effects of this new spike protein on immunopathology upon second exposure in ferrets (not rhesus macaque monkeys; studies show that rhesus monkeys have an immune system that responds to respiratory viruses very differently that humans)?
(3) Disease Enhancement - Organ failure - What are the effects of this new spike protein on the pathologies upon infection in the liver, pancreas, spleen, kidney and brain upon second exposure in ferrets?
(4) Immunointerference 1 - The Vaccinated - What are the effects of this new spike protein on the germinal center, antibody, B-cell and T-cell generation in people who have been previously vaccinated?
(5) Immunointerference 2 - The Naturally Immune - What are the effects of this new spike protein on the germinal center, antibody, B-cell and T-cell generation in people who have previously survived COVID-19?
(6) Safety Upon Exposure - What is the safety profile in people exposed to the mRNA from their original and new vaccine, starting with Day 1 of exposure?
(7) Breakthrough Infection Rates - What is the rate of COVID-19 (Breakthrough infections) in people exposed the mRNA from their original and new vaccine, starting with Day 1 of exposure?
(8) Clinical Relevance - Why are we pursuing a single-antigen targeting vaccine that we know will only confer short-term immunity and lead to a lifetime of endless boosters instead of designing multivalent vaccines that target safe epitopes.
I’m sure there are many other questions. Drop yours in the comments… I’ve called on the leaders of the health freedom movement to start actions toward the FDA to insure proper science and regulatory oversight on this planned new vaccine.
See the latest on pathogenic priming here :
Moody et al. Predicted B Cell Epitopes Highlight the Potential for COVID-19 to Drive Self-Reactive Immunity https://www.frontiersin.org/articles/10.3389/fbinf.2021.709533/full
Lyons-Weiler, 2020. Pathogenic priming likely contributes to serious and critical illness and mortality in COVID-19 via autoimmunity https://pubmed.ncbi.nlm.nih.gov/32292901/
Vojdani et al., Reaction of Human Monoclonal Antibodies to SARS-CoV-2 Proteins With Tissue Antigens: Implications for Autoimmune Diseases https://www.frontiersin.org/articles/10.3389/fimmu.2020.617089/full
Kanduc and Schoenfeld Molecular mimicry between SARS-CoV-2 spike glycoprotein and mammalian proteomes: implications for the vaccine https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499017/