Ron Johnson is a US Senator from Wisconsin. He claims the vaccine approved by the FDA isn't available in the United States. Is he right? If so, doesn't this raise a lot of questions about the vaccine mandates and vaccines themselves?
"Senator Ron Johnson, R-Wisc., claimed that the U.S. still doesn’t have an FDA-approved vaccine as he exposed what was really approved by the government agency on “Fox News Primetime.”
SEN. RON JOHNSON: We do not have an FDA–approved vaccine being administered in the U.S. The FDA played a bait and switch. They approved the Comirnaty version of Pfizer drugs. It’s not available in the U.S. They even admit it. I sent them a letter three days later going “What are you doing?”
What they did is they extended the emergency use authorization for the Pfizer drug vaccine that’s available in the U.S., here that’s more than 30 days later, they haven’t asked that very simple question. If you’re saying that the Pfizer drug is the same as the Comirnaty, why didn’t you provide FDA approval on that? So, there’s not an FDA-approved drug and, of course, they announced it so they could push through these mandates so that people actually think, “Oh, OK now these things are FDA approved.” They are not and again, maybe they should be, but the FDA isn’t telling me why. "
https://www.bing.com/videos/search?q=Se … M%3DHDRSC4
When mandating covid vaccines is unconstitutional and the health organization not approving. We would think these people would be charged and locked with genocide rather being rewarded with trillions.
Funny how most people ignore the most important parts of greatest disasters since world war two. Then continue on the small stuff going nowhere endlessly.
First, I'm opposed to the mandates, and don't put as much trust in the FDA as so many seem to do, but what about the name Comirnaty simply being a "legal distinction?" It seems the FDA is saying that the product that is made from this point on is legally allowed to be named Comirnaty. It seems plausible.
https://www.nebraskamed.com/COVID/you-a … -different
https://www.fda.gov/media/151710/download
Edit: Okay, thinking about, and knowing this is s a "biologic," according to the FDA maybe the two, original Pfizer and Comernity, differ in that the MRNA stems from a different original cell? This way the FDA can say they are 'the same chemically" but ultimately, they are not exactly the same?
I don't know, this is likely all way above my head, but just trying to understand why the FDA would admit that "it's not available in the US" as it would seem they would just state that what we have on the market now is Comirnaty, before it got the name.
https://novascotia.ca/coronavirus/proof … on-policy/
Outrageous vaccines mandates everywhere.
What alarm bells hit me most is being force to go to the city for parttime work. I hear ambulance sirens going off at least 4 times greater than normal. Like shooting fish in a barrel.
That mandate list is insane!!! Especially as it applies to 12 and older! They try it on kids here and they'll have more trouble than they bargained for. I'm far from convinced the vaccine numbers are truthful. My college-aged daughter was forced to get two shots and she's been sick off and on for months now...fevers, swollen and dotted throat, etc. Maddening to me as she was so low risk of COVID anyway.
I have a pretty much full time job (seasonal) that I must submit a vaccine card to in order to work next season in a few months.
Sorry to hear that's happening to your daughter. It would drive me MADD the untouchable Government screws with my family.
To me, the main point is the drug approved by the FDA isn't available in the United States...so what are they using?
It makes me wonder what is going on with the vaccine.
"To me, the main point is the drug approved by the FDA isn't available in the United States...so what are they using?"
Yeah. That's why I speculate about whether it is simply Comirnaty is created after a certain date, or whether it is not exactly the same due to it originating from differing cells. I'll likely never know. The FDA definitely did not do a good enough job explaining as most always.
"COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series." LINK
Pfizer told me by email that the FDA-approved vaccine is identical to the one that has been administered to millions of people around the world...
The FDA notice states: “Although COMIRNATY...is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety....Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15" or to provide the additional dose authorized under an EUA for immunocompromised patients.
So people as young as 12 can continue to receive the Pfizer vaccine under an EUA, while full authorization applies only to those 16 and older.
This legal distinction is largely procedural, and also applies to booster shots: They’ve been endorsed by the Biden administration and the Department of Health and Human Services, but will still require specific FDA approval, which is expected to be coming soon.
To be clear, if the FDA didn’t continue the EUA for the Pfizer shot as well as the full approval, everyone 12-15 years old would instantly have lost their right to the shot.
“I’m not suggesting that the bureaucratic language is a model of clarity,” William Schaffner, a public health expert at Vanderbilt University, “but the conspiracy theory is a very tortured reading.”
The continuation of the EUA “gives the FDA tremendous flexibility to say that even though there’s an approved product, there are reasons we still need this EUA,” says Patricia Zettler, a former counsel to the FDA now teaching law at Ohio State.
LINK LA Times
LINK Washington Post
“I’m not suggesting that the bureaucratic language is a model of clarity,” William Schaffner, a public health expert at Vanderbilt University, “but the conspiracy theory is a very tortured reading.”
Nope, not a model of clarity. I had read the main portion of the FDA PDF. One question I had was the "same formulation." I can see where, with biologics, the "same" not being exactly the same.
I don't believe any one conspiracy theory. I do know that the FDA plays games. I've been involved in them.
If it is "Largely procedural" this implies there are reasons other than procedural for the re-naming and approval. My best guess is that there are minor differences in the manufacturing process, but the FDA finds them so minor that to admit to them would only cause more "vaccine hesitancy." Meanwhile, their tactics lead to more people not trusting vaccines.
More of the unclear wording from the FDA letter:
"There remains, however, a significant amount of PfizerBioNTech COVID-19 Vaccine that was manufactured and labeled in accordance
with this emergency use authorization. The authorization remains in place with respect to the Pfizer-BioNTech COVID-19 Vaccine."
If there was absolutely nothing different about the manufacturing process, why include "that was manufactured and labeled in accordance
with this emergency use authorization?"
I don't think the shots were meant to harm anyone, or anything like that. I think they were absolutely rushed out in order to pad the portfolios of a large handful of people and they did just that. The full approval of some Pfizer vaccine did nothing to change my mind on that.
It all seems so sketchy. Why would there be a need to give FDA approval to something "similar" instead of the vaccine being used?
Government now can say anything to the public THEY want and like the Gods say anything they like and cant do anything wrong.
The same feeling I had touring USSR, yet in many ways covid world order is worse. The communalist system looks great on paper yet most horrible in real live
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