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ABOUT THOSE #JABS… “There is no FDA-approved vaccine to prevent COVID-19.”

Don’t believe it?

Go see for yourselves.

On each of these jab brands’ FACT SHEETS (except the AZ, as it’s been “paused”), near the bottom of the page 1 is, “There is no FDA-approved vaccine to prevent COVID-19.” 

https://www.cdc.gov/vaccines/covid-19/eua/

Comments welcome.

 

12 replies on “ABOUT THOSE #JABS… “There is no FDA-approved vaccine to prevent COVID-19.””

My understanding of vaccines is that they do not prevent you from getting the disease. What they do, is gear up the body’s immune system so that it can fight the virus far more effectively.
Saying ‘it won’t stop you getting the virus’, thereby implying that the vaccine is useless, is misleading at best.

In the context of traditional vaccines, your first paragraph represents that claim.
If the new jabs are so effective, then why isn’t one enough?

A lot of weasel words in these “fact sheets”.
Funny how they left out Death as a “side effect”. isn’t it?
https://www.fda.gov/media/144414/download

This makes it sound like there is no medical reason to take these vaccines and that’s just not true.

The two multi-dose vaccines (Moderna and Pfizer) are authorized but not yet approved.*

An Emergency Use Authorization (EUA) takes 2 months of dosed volunteer observation for safety. Not efficacy which is how effective against the target the vaccine is, but safety for those being dosed with the vaccine. That 2 month requirement was met on 01 December 2020.

A Biological License Approval (BLA), what everyone is calling “FDA approved”, takes 6 months of dosed subject observation. Again and as above, for safety reasons not for efficacy.

I explained in my reply to Becky Gunstream below how “approval vs. authorization” applies to this situation and why not putting the difference in proper context is a deceptive thing to do.

The way things stand right now today, both the Moderna and Pfizer vaccines will have achieved and be issued their BLA (FDA approval) in the next couple months. If you want to be extra cautious I could not fault anyone for waiting for that BLA to be issued.

The way things stand right now there’s nothing that indicates those two vaccines will not be FDA approved in the next couple months or sooner.

There are currently several groups of test subjects who volunteered for vaccination early and will hit the 6 month requirement very soon. The original groups that met the 2 month requirement for issue of an EUA have hit the six month requirement for a BLA on 01 April 2021. Right now the only thing delaying approval via BLA is paperwork. It takes time to review and classify all the incoming data.

Considering the current rate of deployment and all the people who have had these vaccines there is a huge pool of people that will max out the 6 month requirement for BLA (approval) sometime this summer.

Then the anti-vaxxer scare mongers will have to come up with some other argument.

I just looked up the Pfizer records for the BNT162b2 vaccine being currently distributed. Efficacy for not contracting the SARS-cov-2 disease caused by the COVID-19 virus at all is 93%. Efficacy for not contracting a serious, life-threatening case of the disease post vaccination is 100%. The Pfizer vaccine is by all indications working even better against the South African strain as demonstrated by ongoing statistical analysis in South Africa. Those are astonishingly good numbers.

If you want to wait then by all means, that’s your call and I support your decision but at the point a BLA is issued there will be no medical reason for anyone not otherwise contraindicated not to get vaccinated.

Everyone who has been vaccinated will just have a head start on you and you’ll be even less likely to get in a serious situation from the COVID-19 virus. If you get sick and die from SARS-cov-2 between now and then, that’s your privilege too. You should assess your own vulnerabilities, co-morbidity and exposure risks and act in what ever manner you deem best for you. I don’t know nor would I presume to know what is best for you.

That said, I’ve told members of my family who are young and healthy that it’s up to their own discretion whether to get vaccinated or not. They’re very unlikely to die from a case of SARS-cov-2 so their choice isn’t likely to be fatal either way. It won’t hurt them, it might help them, it might not help them enough to notice the difference because a lot of young and healthy people who have gotten ill from COVID-19 don’t seem to be taking it too hard.

I get a flu shot every year because I’m not a spring chicken anymore myself but I’m not scared even a little bit of dying from the flu. I’m around vulnerable family members so there’s that consideration. Plus I don’t want to get sick, or any sicker than I have to be. I get a flu shot in an attempt to spend as few days of my life more miserable than can be avoided as possible. It seems to work out OK for me.. YMMV

So mark my words — At that point when “FDA approval” occurs in the form of a BLA being granted — Another excuse will be offered by people trying to scare you out of getting vaccinated. It’s telling that people who hate the government try to use lack of approval from their hated government as a reason for anything. You should ask me about those kinds of people, I have a lot I can tell you in that arena. When they come up with some other reason to scare you out of getting vaccinated … Yes, I will say “I told you so” whether you want me to or not.

(*The third vaccine in use in the U.S. is the single dose Johnson & Johnson vaccine. Distribution has been suspended in an abundance of caution because there have been six people out of tens of thousands vaccinated who have developed a rare and dangerous blood clotting issue. This does not mean that the vaccine caused the blood clotting problem, it may or may not be something else entirely. Until the cause is determined just to be as safe as possible administration of the Johnson & Johnson vaccine has been temporarily suspended.)

Please tell me I’m not the only one who sees the irony in this! The same people who have spent the last year railing against government overreach are now fussing about the vaccine because it’s not approved by the government.
As Bill once said, it’s irony too rich to go unsavored.

Lol, no you’re not the only one.

Worse yet, that sentence the OP (original poster) cites is taken out of context. There is no “approval” but there is “authorization”. Approval takes longer to get and is an exhaustive process. Here’s what the fact sheets actually say, they’re explaining the difference between approval and authorization …

“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.

The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 in individuals 16 years of age and older under an Emergency Use Authorization (EUA).

For more information on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.”

Revised: 06 April 2021

The emphasis is mine to highlight the facts in those paragraphs. Otherwise it’s a full copy and paste from the document showing actual context.

As you can see from the copy/paste above when taken in context of the paragraph the meaning is much more clear than “The FDA does not approve of these vaccines”, basically saying that there’s no official grant or sanction of these vaccines — Which is what was attempted to be conveyed in this blog posting.

In order to execute the scare mongering being done by this blog poster, he had to cherry pick a sentence out of context. Which is for all practical purpose lying. It’s a deceptive thing to do whether he’s just parroting something he’s seen elsewhere, he actually devised this deception himself or he’s just too ignorant to comprehend what he’s reading. Doesn’t matter, deception is deception and this is clearly deception meant to advance an agenda.

It’s the exact same sort of deception the left used when they said Donald Trump called White Supremacists at Charlottesville VA “fine people”. That’s not what Trump said though he did use the words “fine people on both sides” and if you take that out of context you miss the part where he condemned the White Supremacists soundly and vigorously.

You can safely ignore this guy, several other members and I have pointed out this kind of behavior from this individual already. He’s one of the lunatic fringe types that attach themselves to conservative ideology like lamprey eels or pilotfish. If you choose not to ignore him then look very critically at what he’s saying so that he doesn’t suck you into his fringe ideology.

I guess my logical brain looks at the statement: “There is no FDA-approved vaccine to prevent COVID-19.” and just says TRUE.
Why do I say that? Because my understanding is that none of the vaccines prevent the virus from entering your system (like any vaccine). What they do is allow your body to recognize the threat and attack, so that if you got exposed to a viral load that would make you sick, you may have no symptoms at all.
If you got exposed to enough to make you very sick, you might get mildly ill. All vaccines seems to thus far be effective at preventing the virus that has entered your system from killing you.
So, technically, the vaccine does not prevent the Covid-19 virus from entering your body, but it does significantly limit the damage if it does.

Exactly so. Any vaccine allows your natural systems to recognize and defeat a disease before it has a chance to overwhelm your natural defenses.

It does not prevent a virus from entering your system, what it prevents is reproduction at a catastrophic rate of those viruses that are already inside your body.

This also has the side effect of making you virtually non-contagious. Because generally a virus has to reach a certain saturation point before you can begin shedding it to the environment. Which is what makes you contagious and allows you to pass on your illness to other people.

Viruses have a reasonably short lifespan as individual units. If you’re vaccinated the virus enters your system, tries to replicate, fails and then lives out it’s short lifespan and dies itself. It never leaves your body and it never has a chance to infect other people.

As you point out, no vaccine is 100% effective (though the COVID vaccines are running in the low 90th percentiles and this seems to be improving as more statistical mass becomes available) but giving your immune system the head-start of a vaccine before you become infected still works to limit virus reproduction and so limits the severity of the disease if it does become symptomatic.

The greater the viral load you carry, the more and stronger the symptoms you exhibit.

I get that you mean nothing “prevents COVID-19” is a true statement because nothing stops the virus from entering your body. The vaccines however are doing a very good job of preventing SARS-cov-2, which is the actual disease caused by the virus.

If you are symptomatic it’s also likely that you are contagious so bear that in mind. Most likely if you’re symptomatic you’re sick so you probably wouldn’t be running around spreading the disease anyway. However, if you have any symptoms at all you should probably consider postponing visits to elderly/vulnerable relatives and friends until you feel better.

All of that said, the statement “There is no FDA approval” is an out-of-context “truth” that is meant to convey an idea that is not true. I explained that at great length in my stand-alone comment on this blog post.

If you are symptomatic it’s also likely that you are contagious so bear that in mind. 

This, 100%. If our dictators (governors) had actually explained this and simply told people, if you are sick, stay home. If you stay sick or get worse, seek medical help; much of the last year’s woes would have been avoided.
When people ask me why I don’t wear a mask all the time like a good little sheep I reply with 2 things 1) The mask is ineffective as my beard negates even the small good it might do if one wears a well-fitted device. and 2) I am not sick.
How do you know you’re not sick they ask. I have no symptoms. Therefore even if I have a small quantity of virus in my body, the load is not sufficient for me to transmit; or else I would have symptoms.

Roger that on the common sense when it comes to being sick. It’s like after tens of thousands of years of billions of Moms telling us how to deal with being sick — All of a sudden we need a mandate to know to stay home and get better?

Has modern man really gone completely stupid?

Now really, I could understand if they issued “guidelines” that were meant to be followed voluntarily. Things like “stay out of nursing homes if you’re sick” and “if you have elderly or vulnerable people in your house be sure to wash your hands when you come in from public places”. Common sense reminders like that should be enough for even the stupidest of the stupid.

Of course electrical appliances have to have tags on them warning people not to use them in bathtub so …

Obviously there are dimmer bulbs on our social tree.

When people ask me why I don’t wear a mask all the time like a good little sheep I reply with 2 things 1) The mask is ineffective as my beard negates even the small good it might do if one wears a well-fitted device. and 2) I am not sick.

Pretty much what I tell people too. I have a really long “old man of the mountains” kind of beard, a mask is just ludicrous … And I’m not freakin’ shaving off my beard to wear a damned mask either.

But then, I’m an asshole … Just for shits and giggles I often display an EGA (Marine Corps logo; Eagle, Globe and Anchor) somewhere prominently on my person and take my little dog into stores with me. If anyone says anything I look at them with just a little bit of crazy and in a very serious and sincere voice I tell them —

“She’s my PTSD support dog. Go ahead, take her away from me and see what happens”.

Even the karen-est of Karens has not tried to push things past that point … yet.

If they do my I will just laugh and my dog and I will leave.

Like I said elsewheres, “colorful” runs in my family. 😉

Take her away see what happens. Love it.
My favorite instruction label on anything is on a book of matches. Close cover before striking. It’s a freaking match. If you don’t know how to use it, don’t.

Just for fun, look up George Carlin, Germs. Funny as hell.
When I was a kid I got chicken pox. Neighbors brought their kids over, then my folks went on a cruise leaving me with my aunt. Happy scratching.

Becky Gunstream, thanks for your comment.

You’re interpretation about me “…fussing about the vaccine because it’s not approved by the government.” is incorrect.
The point is that the official gov. source openly admits that they’re experimenting on the population with an “experimental medical protocol”, not a “vaccine”.
mRNA does not meet the legal definition of a vaccine, and should not be touted as such(truth in advertising laws). Moderna developed the bio-encoding tech with DARPA. 100% the test ferrets in the animal trials died.
Kind of convenient to skip the animal trial for the “covid-19 vaccines” isn’t it?
Well, good news. The folks who got #jabbed are the animal trials.
There’s the irony from my perspective.

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