What is an mRNA vaccine?
What is an mRNA vaccine?
Right now there at least 48 companies working on possible vaccines for the Covid-19 problem. Most of them are relying on the medical industry standards set on past accepted methods and protocol, but the front runners are a new breed of innovators, who hope to try out something truly unique, that’s never been done before. It’s based on cutting edge bio-engineering techniques, and I am here to explain the basics of that term as it has been presented to me.
What exactly is an mRNA vaccine? We all know what DNA is, it is the blue print of life-your genetic code. RNA is what translates, or reads the code, and responds to the directive, mostly creating proteins that activate or de activate everything about your existence. mRNA is created during the process of transcription, editing that code. An enzyme is activated and converts the gene into primary mRNA. It theorizes that using your “junk” DNA slots, it will insert a line of synthetic code. (You know, as if you where a computer).
That synthetic addition will be assimilated, read, and responded to in the appropriate way-in a process called “transcription”, going to work on producing an enzyme reaction that will result in the appropriate protein, creating an immune response that will not only be yours, but your descendants as well, as it is now part of your genetic coding, and will be duplicated in your offspring.
Sounds pretty cool, right?
Congratulations, you, and your bloodline, have just become the first generation to be genetically modified. You know, like the infertile mosquitoes. Lets hope there aren’t any freakish side effects.
Up to this point in medical history, a vaccine was administered based on the theory that if small molecules of a disease that were inert, or live cells in minuet amounts were introduced to the blood system of an individual, your natural immune system would identify and codify the intruder, and make it’s own antibodies, so when and if you were ever exposed to a ‘”live” version of the virus or bacterium, you would be essentially immune from infection, or if you did contract the disease, it would be a less harmful version.
There are a few types currently in use:
*Live, attenuated vaccines fight viruses and bacteria. These vaccines contain a version of the living virus or bacteria that has been weakened so that it does not cause serious disease in people with healthy immune systems. Because live, attenuated vaccines are the closest thing to a natural infection, they are good teachers for the immune system. Examples of live, attenuated vaccines include measles, mumps, and rubella vaccine (MMR) and varicella (chickenpox) vaccine. Even though they are very effective, not everyone can receive these vaccines. Children with weakened immune systems—for example, those who are undergoing chemotherapy—cannot get live vaccines.
• Toxoid vaccines prevent diseases caused by bacteria that produce toxins (poisons) in the body. In the process of making these vaccines, the toxins are weakened so they cannot cause illness. Weakened toxins are called toxoids. When the immune system receives a vaccine containing a toxoid, it learns how to fight off the natural toxin. The DTaP vaccine contains diphtheria and tetanus toxoids.
• Inactivated vaccines can also fight viruses and bacteria. These are produced by using cells of germs that have been killed during the process of making the vaccine. The inactive polio vaccine is an example of this method. Inactive vaccines produce immune response in a different way than a live, attenuated one, and often , multiple doses are required to build up the proper immunity.
There is also a standard protocol in place to ensure the safety and efficacy of these products before they are given to actual humans. The requirements were put in place in 1944.
Before a vaccine is approved and administered, it must first pass through certain requirements.
Stages of Vaccine Development and Testing
In the United States, vaccine development and testing follow a standard set of steps. The first stages are exploratory in nature. Regulation and oversight increase as the candidate vaccine makes its way through the process.
Stages of Vaccine Development and Testing
In the United States, vaccine development and testing follow a standard set of steps. The first stages are exploratory in nature. Regulation and oversight increase as the candidate vaccine makes its way through the process.
First Steps: Laboratory and Animal Studies
Exploratory Stage-
This stage involves basic laboratory research and often lasts 2-4 years. Federally funded academic and governmental scientists identify natural or synthetic antigens that might help prevent or treat a disease.
Pre-Clinical Stage1-2 years
Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. Animal subjects may include mice and monkeys. These studies give researchers an idea of the cellular responses they might expect in humans. They may also suggest a safe starting dose for the next phase of research as well as a safe method of administering the vaccine.
IND Application
A sponsor, usually a private company, submits an application for an Investigational New Drug (IND) to the U.S. Food and Drug Administration. The sponsor describes the manufacturing and testing processes, summarizes the laboratory reports, and describes the proposed study. An institutional review board, representing an institution where the clinical trial will be conducted, must approve the clinical protocol. The FDA has 30 days to approve the application.
Once the IND application has been approved, the vaccine is subject to phase three, phase 1.
This is when it goes into phase 1 of Human trial test subjects. The accepted protocol is 2-7 years blind placebo comparisons, monitoring for side effects, safety and interaction.
However, On April 27th, 2020, Moderna was granted an IND approval for the mRNA vaccine, skipping the first three phases altogether-perhaps feeling time was of the essence.
Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus
April 27, 2020 at 4:30 PM EDT
600 participant Phase 2 study to begin upon IND acceptance and safety data from ongoing NIH-led Phase 1 study
Planning underway for Phase 3 study; study expected to begin in the fall of 2020
CAMBRIDGE, Mass.-Apr. 27, 2020–Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug
Gates Foundation’s $20 million funding could potentially grow into a total $100 million commitment—including the HIV antibody project—toward development of additional mRNA-based treatments for various infectious diseases, Moderna said.
“The foundation’s mission to help all people lead healthy and productive lives is well aligned with Moderna’s mission to deliver on the promise of transformative mRNA science to bring new medicines to patients,” Moderna CEO Stéphane Bancel said in a statement.
Moderna said the development effort would be led by its infectious disease–focused venture company, Valera. Launched in January 2015, Valera has focused exclusively on using Moderna’s platform to advance vaccines and therapeutics for prevention and treatment of viral, bacterial, and parasitic infectious diseases.
Valera’s efforts have resulted in the demonstration of preclinical efficacy of Moderna’s mRNA-based vaccines in multiple viral disease models, Moderna said.
In the partnership with the Gates Foundation, Valera will apply its mRNA vaccine platform as well as Moderna’s drug platform Messenger RNA Therapeutics™. Designed to produces human proteins, antibodies, and entirely novel protein constructs inside patient cells
In fact, within 42 days of getting the green light, they had a test vaccine in hand.
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection.
There’s some Warp Speed action, right?
As of this date,the “success” rate in active human trials conducted is 80%. That is apparently good enough to be declared a success, and billions of these doses are now in production.
Both Pfizer and Moderna are apparently in the phase three trials already after just a few months of research.
Because vaccines are technically not a medicine, they are legally free of retroactive damage liability and under no obligation to publish public double blind placebo trials or adher to any regulatory standards except their own. Medicines have very strict standards and must show data on repeatable results. Vaccines do not fall into this category.
The problem is-although the vaccine may or may not have a positive effect on Covid -19, we have absolutely no idea of how this will effect each individual, in the short or long term. A one-size-fits-all genetic modifier, administered to the entire human race at once, sounds a lot like using a hammer to open a rose. It’ll do the job, but…..is that really our only option?
Also, for the record, biological creations, in whole or in part, can potentially be patented, the laws are very sketchy, and you may need occasional upgrades to continue to function properly.
I am not an ant-vaxxer. I am against Big Pharma pushing untested, unregulated and potentially unsafe gene altering materials on the human race, and mitigating our sovereignty in exchange for cold hard cash, under the guise of making people safe and healthy. That is strickly my opinion. I would love nothing more than to be proven wrong, and see a successful cure come out, with complete transparency and restoration of our shared health and happiness.
This article is factual, the links to the websites are provided.
I care deeply about the fate of my fellow Earthlings, and I have no motive, but love.
Educate yourself.
There are pro’s and cons to everything for sure, so use your own best judgments, and be safe and happy. Do your own research (while you still can)..currently this information is publicly available.
https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation
https://www.genengnews.com/topics/omics/moderna-wins-initial-20m-grant-from-gates-foundation/
https://www.darpa.mil/program/pandemic-prevention-platform
https://www.youtube.com/watch?v=IfnJi7yLKgE
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