How IT Works?
Instead of the standard vaccines where viral proteins are used to immunize, an mRNA vaccine provides a synthetic mRNA of the virus, which the host body then uses to produce the viral proteins itself.
The mRNA vaccines basically mimic the natural infection of the virus, but they contain only a short synthetic version of the viral mRNA which encodes only the antigen protein. Since the mRNA used in vaccination cannot become part of the person’s chromosomes, they are safe to use. Such mRNA vaccines would also be safer than the weakened viral or protein-based vaccines because they do not carry the risk of the injected virus becoming active, or a protein contamination.
Potential shortfalls is that Coronavirus (common cold species), naturally doesn’t initiate a strong antibody memory immunity. Potential dangers associated with a viral mimicking protein is the COVID19 is a smart virus and can use any potential encoded message for its own mutation evolution. This can lead to unwanted secondary and tertiary activation of the virus and cause reinfection, as well as, antibody dependent enhancement (ADE) and undesirable phenomenon, initiating antibody flooding and inflammatory cytokine crisis.
Clinical Trials Clue Us In
It is interesting to read about the brilliant design of this trial. There are many points of interest, in particular, the exclusion criteria for any prospective patients recruited. First inclusion / exclusion is age. Can only be considered if you are between the age of 18–55. I understand the medical rationale but it totally counters the protection of aged population where there is high risk.
After concluding that age is a possible adverse risk factor in safety of the vaccine, I proceeded to review NIH’s listed exclusion criteria for the rest of the trial risk. See the link below:
The world population already is suffering with immune related risk and exposed to a complicated COVID19 virus, as well as, other exclusions. World population of an already infected people?
Question? Who do they believe they are going to be inoculating after the safety trial? People that do not struggle with pre-existing conditions? What about people that are on drugs that already demonstrate risk of autoimmune complications, susceptibility to infection and other health complications. If they list possible safety concerns in exclusions what will the effect be on a struggling pandemic with the associated complexities that already exist in the world population as I mentioned above?
Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis SARS CoV-2 Infection
A subject who meets any of the following criteria will be excluded from participation in this study:
- Positive pregnancy test either at screening or just prior to each vaccine administration.
- Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
- Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.*
- *Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject’s successful completion of this trial.
- Presence of self-reported or medically documented significant medical or psychiatric condition(s).*
- *Significant medical or psychiatric conditions include but are not limited to: Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma) requiring daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years. Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.
- Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
- Neurological or neurodevelopmental conditions (e.g., history of migraines in the past 5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
- Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
- An autoimmune disease, including hypothyroidism without a defined non-autoimmune cause, localized or history of psoriasis.
- An immunodeficiency of any cause.
- Has an acute illness*, as determined by the site PI or appropriate sub-investigator, with or without fever [oral temperature > / = 38.0 degrees Celsius (100.4 degrees Fahrenheit)] within 72 hours prior to each vaccination.
- *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
- Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies at screening.
- Has participated in another investigational study involving any investigational product* within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
- *study drug, biologic or device
- Currently enrolled in or plans to participate in another clinical trial with an investigational agent* that will be received during the study-reporting period.**
- *Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication.
- **13 months after the first vaccination.
- Has previously participated in an investigational study involving lipid nanoparticles (LNPs) (a component of the investigational vaccine assessed in this trial).
- Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
- Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.*
- *Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
- Received immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
- Has any blood dyscrasias or significant disorder of coagulation.
- Has any chronic liver disease, including fatty liver.
- Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before the first vaccine administration.
- Has a positive test result for drugs of abuse at screening or before the first vaccine administration. If cannabis is the only detected drug, inclusion is permitted.
- Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region).
- Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination.
- Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination.
- Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
- Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
- Current use of any prescription or over-the-counter medications within 7 days prior to vaccination, unless approved by the investigator.
- Plan to travel outside the US (continental US, Hawaii, and Alaska) from enrollment through 28 days after the second vaccination.
What about people suffering with pre-existing medical conditions that haven’t found solutions for their current health struggles?
What about complications associated with existing mitochondrial disorders, other serious infections and pre-existing viral complications?
What about cancer patients that need personalized solutions to fight their cancer?
Precision and Personalization
We are in the precision / personalization era of medicine! We need solutions that will initiate and work with a person’s individual immune susceptibility and challenges directly by action-based treatment. We have the technology and ability to type the genetics and the immune editing features of an individual’s susceptibility and immune challenges they face from struggles resulting from their disease.
Mass scale vaccination with a huge exclusion criteria is not encouraging at all.
Smart Viruses / Smart Defense
In the case of complicated and highly mutated viruses like the novel virus SARS-CoV-2 COVID19, a multi-mechanism and multi-technological approach is the best way to accelerate / blitzscale a treatment focus for individual’s already infected, as well as a prophylactic design.
These designs can be fast tracked in real time surveillance that are world population effective >95% in weeks, not months or longer.
#questions. #gobsmacked. #concerns #critical #medical. #decisions