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Message
Need help - FDA Approved vaccine for COVID???
Posted on 3/19/21 at 9:55 am
Posted on 3/19/21 at 9:55 am
Question - Can someone direct me to the vaccines that are FDA approved for COVID?
EAU FACT SHEETs
All of these fact sheets claim that these are "COVID-19 vaccines". BUT the cdc defines a vaccine as cdc vaccine definition
I'm so confused...
EAU FACT SHEETs
quote:
The Pfizer-BioNTech COVID-19 Vaccine is a vaccine and may prevent you from getting
COVID-19. There is no U.S. Food and Drug Administration (FDA) approved vaccine to
prevent COVID-19.
quote:
WHAT IS THE PFIZER-BIONTECH COVID-19 VACCINE?
The Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine that may prevent
COVID-19. There is no FDA-approved vaccine to prevent COVID-19.
quote:
The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19.
There is no U.S. Food and Drug Administration (FDA) approved vaccine to prevent COVID-19.
quote:
WHAT IS THE MODERNA COVID-19 VACCINE?
The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There
is no FDA-approved vaccine to prevent COVID-19
All of these fact sheets claim that these are "COVID-19 vaccines". BUT the cdc defines a vaccine as cdc vaccine definition
quote:
Vaccines: The Basics
Vaccines contain the same germs that cause disease. (For example, measles vaccine contains measles virus, and Hib vaccine contains Hib bacteria.) But they have been either killed or weakened to the point that they don’t make you sick. Some vaccines contain only a part of the disease germ.
A vaccine stimulates your immune system to produce antibodies, exactly like it would if you were exposed to the disease. After getting vaccinated, you develop immunity to that disease, without having to get the disease first.
quote:
WILL THE PFIZER-BIONTECH COVID-19 VACCINE GIVE ME COVID-19?
No. The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and
cannot give you COVID-19.
quote:
WILL THE MODERNA COVID-19 VACCINE GIVE ME COVID-19?
No. The Moderna COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you
COVID-19.
I'm so confused...
8
Posted on 3/19/21 at 9:56 am to mooseofterror
NONE are approved.
Posted on 3/19/21 at 9:57 am to mooseofterror
I recommend smoking pork butts to at least an internal temperature of 195, if you want it to pull easily and be tender. But pork chops are safe at around 145 degrees, and won't be dried out.
Best I can do as far as FDA bullshite is concerned. They used to want you to make meat inedible.
Best I can do as far as FDA bullshite is concerned. They used to want you to make meat inedible.
Posted on 3/19/21 at 10:00 am to mooseofterror
I’ve read that they are MRNA vaccines. Not sure 100% what that means but the public not knowing the difference is unsettling.
I will not be taking it.
I will not be taking it.
Posted on 3/19/21 at 10:05 am to Lambchops11
quote:
I’ve read that they are MRNA vaccines.
Pfizer and Moderna are mRNA vaccines. J&J is a typical vaccine like the flu vaccine.
ETA: Not taking any of them.
This post was edited on 3/19/21 at 10:07 am
Posted on 3/19/21 at 10:11 am to mooseofterror
There are three vax that have been approved under an emergency use order.
To get "full" approval takes much longer.
Is this supposed to be a gotcha post? Everyone knows this.
To get "full" approval takes much longer.
Is this supposed to be a gotcha post? Everyone knows this.
Posted on 3/19/21 at 10:13 am to Lambchops11
quote:
MRNA vaccines
My understanding this is genetic therapy.
Modified genes are introduced with the expectation the body's immune system will develop a response to combat it. Supposedly the modified cells injected die shortly after being introduced, from heat or something like that, really sketchy on that part.
Brand new first of it's kind type stuff. Length of efficacy at lessening symptoms is unknown (4-24 months last guess presented by pharma companies).
The only immunity claimed to be provided is to Big Pharma who is immune from any and all effects intended or otherwise for these "vaccines".
Posted on 3/19/21 at 10:13 am to mooseofterror
Vaccines are defined by function, not mechanism of action.
This...
...is EXACTLY what they do. New technology used to create the response is still creating the response.
Obtuse arse people.
This...
quote:
A vaccine stimulates your immune system to produce antibodies, exactly like it would if you were exposed to the disease. After getting vaccinated, you develop immunity to that disease, without having to get the disease first.
...is EXACTLY what they do. New technology used to create the response is still creating the response.
Obtuse arse people.
Posted on 3/19/21 at 10:16 am to WPBTiger
quote:
J&J is a typical vaccine like the flu vaccine.
So much stupidity. Let me know what adenovirus vaccines have been approved for use thus far in the history of man. I'll give you a hint, it's a REALLY low number and JUST happened about two years ago.
Most of you don't know what "typical vaccines" are.
Posted on 3/19/21 at 10:17 am to Lambchops11
quote:
I’ve read that they are MRNA vaccines. Not sure 100% what that means
It's not like the information isn't readily available for anyone that wants to know.
quote:
but the public not knowing the difference is unsettling.
Yeah, it should be unsettling that 90% of the population in our country is illiterate. I agree.
Posted on 3/19/21 at 10:20 am to LSUFanHouston
Well, people keep using the term "mRNA Vaccine", but that just doesn't make sense if we look at the definition of a vaccine.
If possible I'd like to hear some different explanations so that I can be better informed.
types of vaccines
Live attenuated
inactivated
subunit/conjugate
the mRNA "version" sounds a lot more like gene therapy to me.
If possible I'd like to hear some different explanations so that I can be better informed.
types of vaccines
Live attenuated
inactivated
subunit/conjugate
the mRNA "version" sounds a lot more like gene therapy to me.
Posted on 3/19/21 at 10:25 am to S1C EM
quote:
Vaccines are defined by function, not mechanism of action.
umm....
Webster
quote:
A preparation of a weakened or killed pathogen, such as a bacterium or virus, or of a portion of the pathogen's structure that upon administration to an individual stimulates antibody production or cellular immunity against the pathogen but is incapable of causing severe infection.
Dictionary.com
quote:
any preparation used as a preventive inoculation to confer immunity against a specific disease, usually employing an innocuous form of the disease agent, as killed or weakened bacteria or viruses, to stimulate antibody production.
CDC
quote:
Vaccines contain the same germs that cause disease. (For example, measles vaccine contains measles virus, and Hib vaccine contains Hib bacteria.) But they have been either killed or weakened to the point that they don’t make you sick. Some vaccines contain only a part of the disease germ.
HHS
quote:
Vaccine
A vaccine is made from very small amounts of weak or dead germs that can cause diseases — for example, viruses, bacteria, or toxins. It prepares your body to fight the disease faster and more effectively so you won’t get sick.
Posted on 3/19/21 at 10:25 am to mooseofterror
From fda.gov:
quote:
Q: What is the FDA’s role in approving vaccines and what is being done to produce a COVID-19 vaccine?
The FDA regulates vaccines. Vaccines undergo a rigorous review of laboratory, clinical and manufacturing data to ensure the safety, effectiveness, and quality of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects.
On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for the use of the?Pfizer-BioNTech COVID-19 Vaccine. On December 18, 2020, the FDA issued an EUA for the use of the Moderna COVID-19 Vaccine. And on February 27, 2021 the FDA issued an EUA for the use of the Janssen COVID-19 Vaccine. The issuance of an EUA is different than an FDA approval (licensure) of a vaccine.
In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits. And if the benefit-risk assessment is favorable, the product is made available during the public health emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine, the FDA then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the agency.
In addition to supporting product development for high priority COVID-19 vaccines, the FDA continues to expedite clinical trials for additional vaccine candidates, providing timely advice to and interactions with vaccine developers.
Posted on 3/19/21 at 10:25 am to Lambchops11
quote:
THEORY VS. REALITY
Like much in biotech, the concept of mRNA-based therapeutics is elegant in theory, yet rough in reality.
Reason 1: The relative instability of the mRNA molecule itself; mRNA traveling through the bloodstream would typically be degraded by nucleases — enzymes that break down nucleic acids.
Reason 2: “Foreign mRNA” coming from outside of the cell could trigger an immune response; our immune systems have evolved to recognize foreign mRNA as bad.
Reason 3: Delivery of mRNA therapy is difficult. Right now the approach that appears to be having the most success is encasing the mRNA in a lipid nanoparticle for delivery to cells.
Bringing mRNA drugs to market involves designing chemically modified mRNA that is more stable (resistant to nucleases) and less visible to immune cells than unmodified mRNA. These modified mRNA molecules are called “nucleotide analogs” because they are similar but different from naturally occurring nucleotides.
https://weekly.biotechprimer.com/abcs-of-mrna-vaccines/
Keyword TERT - Changing the mRNA - The weapon in the vaccines.
To put it in layman's terms, it effects your DNA by attacking the cells to the marrow from protecting itself, mRNA (is the genetic protection code to the DNA, by weakening or degrading, it will cause the weakening of your biologic defense system.
THEORY VS. REALITY
Like much in biotech, the concept of mRNA-based therapeutics is elegant in theory, yet rough in reality.
Reason 1: The relative instability of the mRNA molecule itself; mRNA traveling through the bloodstream would typically be degraded by nucleases — enzymes that break down nucleic acids.
Reason 2: “Foreign mRNA” coming from outside of the cell could trigger an immune response; our immune systems have evolved to recognize foreign mRNA as bad.
Reason 3: Delivery of mRNA therapy is difficult. Right now the approach that appears to be having the most success is encasing the mRNA in a lipid nanoparticle for delivery to cells.
Bringing mRNA drugs to market involves designing chemically modified mRNA that is more stable (resistant to nucleases) and less visible to immune cells than unmodified mRNA. These modified mRNA molecules are called “nucleotide analogs” because they are similar but different from naturally occurring nucleotides.
https://weekly.biotechprimer.com/abcs-of-mrna-vaccines/
Keyword TERT - Changing the mRNA - The weapon in the vaccines.
To put it in layman's terms, it effects your DNA by attacking the cells to the marrow from protecting itself, mRNA (is the genetic protection code to the DNA, by weakening or degrading, it will cause the weakening of your biologic defense system.
This post was edited on 3/19/21 at 10:26 am
Posted on 3/19/21 at 10:25 am to BiteMe2020
quote:
I recommend smoking pork butts to at least an internal temperature of 195, if you want it to pull easily and be tender. But pork chops are safe at around 145 degrees, and won't be dried out.
Best I can do as far as FDA bullshite is concerned. They used to want you to make meat inedible.
at 195, the collagen and fats in the Boston butt break down and it can be "pulled"
145 internal temp kills and makes safe for consumption
Posted on 3/19/21 at 10:25 am to mooseofterror
quote:
mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.
quote:
COVID-19 mRNA vaccines give instructions for our cells to make a harmless piece of what is called the “spike protein.” The spike protein is found on the surface of the virus that causes COVID-19.
COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the immune cells, the cells use them to make the protein piece. After the protein piece is made, the cell breaks down the instructions and gets rid of them.
Next, the cell displays the protein piece on its surface. Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19.
At the end of the process, our bodies have learned how to protect against future infection. The benefit of mRNA vaccines, like all vaccines, is those vaccinated gain this protection without ever having to risk the serious consequences of getting sick with COVID-19.
quote:
Facts about COVID-19 mRNA Vaccines
They cannot give someone COVID-19.
mRNA vaccines do not use the live virus that causes COVID-19.
They do not affect or interact with our DNA in any way.
mRNA never enters the nucleus of the cell, which is where our DNA (genetic material) is kept.
The cell breaks down and gets rid of the mRNA soon after it is finished using the instructions.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
Posted on 3/19/21 at 10:25 am to dakarx
quote:
My understanding this is genetic therapy.
Because you listen to "doctors" who aren't actually doctors. The same kind that literally think your wife is fricking witches and demons in her sleep.
quote:
Modified genes are introduced with the expectation the body's immune system will develop a response to combat it.
Nope.
quote:
Supposedly the modified cells injected die shortly after being introduced, from heat or something like that, really sketchy on that part.
The active ingredient is quickly expelled from your body, that much is true.
quote:
Brand new first of it's kind type stuff.
Nope. Tech has been around for over two decades. But funding and logistics in transporting were always barriers until the governments of the world decided they needed to flood the companies doing the research with money.
quote:
Length of efficacy at lessening symptoms is unknown
Current data shows that they prevent both illness and transmission. That was not tested for in tirals because it takes much longer to establish efficacy when that is the goal. Hospitalizations and deaths are much easier to measure when time is of the essence.
quote:
The only immunity claimed to be provided is to Big Pharma who is immune from any and all effects intended or otherwise for these "vaccines".
Wrong. And I'm sure you've been entering plenty of restaurants with the same immunity of late.
Posted on 3/19/21 at 10:27 am to S1C EM
quote:
Yeah, it should be unsettling that 90% of the population in our country is illiterate. I agree.
By being skeptical of not wanting to take a vaccine without full FDA approval and not an EUA?
Posted on 3/19/21 at 10:27 am to tigeraddict
quote:
at 195, the collagen and fats in the Boston butt break down and it can be "pulled"
145 internal temp kills and makes safe for consumption
I once - once - smoked a pork loin to 195 degrees. Sure, it was tender, but the meat is so lean that it was really not all that great. You really do need to know your cuts of meat to understand FDA guidelines.
I'd recommend smoking Asian puntang to at least 195 degrees if you want to avoid COVID AND have something worth eating.
Posted on 3/19/21 at 10:31 am to DykonIcon
Urgent Open Letter from Doctors and Scientists to the European Medicines Agency regarding COVID-19 Vaccine Safety Concerns
https://archive.vn/JFyT5
original link scrubbed from the web:
https://doctors4covidethics.medium.com/urgent-open-letter-from-doctors-and-scientists-to-the-european-medicines-agency-regarding-covid-19-f6e17c311595
https://archive.vn/JFyT5
original link scrubbed from the web:
https://doctors4covidethics.medium.com/urgent-open-letter-from-doctors-and-scientists-to-the-european-medicines-agency-regarding-covid-19-f6e17c311595
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