This is why I fear mRNA vaccines.

a reply to: KansasGirl

They are exempted from requiring approval by the FDA in order to give them to the public.

No exemption. The FDA granted the EUA, actually. That is approval for use. By the FDA. To provide the vaccine to the public (16 and over).

www.fda.gov...

originally posted by: Phage
a reply to: KansasGirl

They are exempted from requiring approval by the FDA in order to give them to the public.

No exemption. The FDA granted the EUA, actually. That is approval for use. By the FDA. To provide the vaccine to the public (16 and over).

www.fda.gov...

On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

EMERGENCY USE

a reply to: Doctor Smith

Yes I know. That's what EUA stands for.

The claim was this:

They are exempted from requiring approval by the FDA in order to give them to the public.

The claim is wrong. The FDA approved emergency use for the general public (over 16).

An Emergency Use Authorization (EUA) is one of several tools the FDA is using to help make certain medical products available quickly during the COVID-19 pandemic. In certain emergencies, the FDA can issue an EUA to provide access to medical products that may potentially be used when there are no adequate, approved, and available options. The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance. When evaluating an EUA, we carefully balance the potential risks and benefits of the products based on the data currently available. EUAs are effective until the emergency declaration ends. EUAs can also be revised or revoked by the FDA at any time as we continue to evaluate the available data and patient needs during the public health emergency.

Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19

a reply to: Doctor Smith

a reply to: Phage

What is an Emergency Use Authorization (EUA)? An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.

Under an EUA, FDA may allow the use of UNAPPROVED medical products.

What is an Emergency Use Authorization (EUA)?

a reply to: Doctor Smith

Yes. But the person I was replying to seemed to think that the FDA played no part in the issuance of the EUA. That the manufacturers were somehow "exempt" from FDA actions. This is incorrect. It was the FDA which issued the EUA (which allows distribution to the public).

The FDA granted use and the FDA can revoke that at any time.

originally posted by: panoz77
a reply to: Violater1

I tend to agree with the no "off switch", but if that is the case and "the experts" obviously know this, why are they now pushing for boosters every 6 months? Are they just trying to really make sure that the sheep taking this experimental shot are doomed into a nasty downspiral of miserable slow death?

We may choose to consider the possibility : that the ' Experts™ ', are owned and operated by the same folks that commission the scary models ; that 'officially' declared the Plandemic™, that keep blasting our TV-screens with scary scenarios and numbers ; and dictate the public-health policy of supposedly sovereign nations : are actually the same folks making mega billions in profits from the Scamdemic™.

But of course : anyone doubting that Big-Pharma™ has totally changed their spots, and despite being egregious repeat offenders, and are now angels and saviors : is an unhinged whack-a-doodle, out-of-touch conspiracy theorist.

It's probably not a business model, that a 'normal' corporation would do anything to continue...

originally posted by: chr0naut

When you come out of your mum's basement, I suspect you'll still be the same pallid nerd.

Naw that was last year when I turned 60...Still a nerd though.

originally posted by: KansasGirl

originally posted by: chr0naut

originally posted by: KansasGirl

originally posted by: chr0naut
a reply to: Violater1


And the process of testing and approval of a vaccine means that we have a good idea of how the human immune system responds to the vaccine, before we even approve it for the general populace.

I don’t know the status of approval in your country, but here in the US, NONE of these are approved for the general populace. The FDA has exempted them from having to be approved. They have not been approved.

The FDA allowed them to fast track, but they were fully tested and are now approved for significant portions of the populace. As confidence grows, they will likely be approved for other portions of the populace, like infants, children and the elderly. At no stage was an untrialled vaccine bulk approved.

Again- they are not approved in the US.

Most COVID-19 vaccine variants have been approved for emergency use in the US. But as I mentioned, that does not mean the approval for all people of all age groups and medical conditions.

They are exempted from requiring approval by the FDA in order to give them to the public. Look it up before you spout lies about not even your own country.

No, there is a process for gaining approval for use as an EUA. After the FDA has evaluated the EUA requests, it grants approval for the vaccines and this is under specific circumstances, as caution would naturally dictate.

That does not mean that the vaccines are untried or in an experimental phase. Nor does it mean that they have not been approved within particular criteria.

They do not have the years in trial nor numbers and types of people tested in order to be approved by the FDA.

The FDA is still in process of working towards a more complete approval of the vaccines. I am fairly sure that they are looking at the demographics of the vaccines as shown by their recent hold they put on the use of the Johnson & Johnson vaccine after there were some potential medical issues that occurred.

The situation is ongoing but so far the vaccines have been very well tolerated and adverse reactions minimal. On the other hand the pathogen vaccinated against, against which they work, has killed more than half a million people in a year in the US alone. People will likely continue to die in similar numbers, or even greater, if no-one does anything.

Most effective medicines have side effects, but you don't just refuse access to those medicines just because they have rare side-effects. It is an ethical and medical decision that must be made responsibly by people continually evaluating the situations.

originally posted by: Xtrozero

originally posted by: chr0naut

When you come out of your mum's basement, I suspect you'll still be the same pallid nerd.

Naw that was last year when I turned 60...Still a nerd though.

Much the same for me. My mum lives in another country, though, so no low-cost basement accommodation for me.



Are you showing any Lepidopteral characteristics yet?

I like Phage's counter arguments here.

I'm not a geneticist, but I've taken a few classes.

Even if mRNA would get into a cell's nucleus, what's the big problem here? IIRC cells that sustain malformation to the nucleus just end up sending out the kill me now code, and they get taken care of. Your body kills your own cells all day long, to prevent cancer.

That's not what the vaccines were designed to do, so even if it happens, it's probably just fringe examples.

mRNA, proteins, enzymes, DNA, etc... They're designed to fit certain places, they can go other places, but they're most likely going to end up going where they are supposed to. Anything abnormal happens, and your body has natural fail safes to deal with fringe cases.

If it were so easy to change a person's DNA permanently, the sun would be more deadly to us, than these vaccines. Do you know how many cosmic rays bombard your body, all day long, even through solid walls and ceilings? Go watch a cloud chamber, homie.


I am somewhat concerned with a couple facts here though, to pivot sides a little...
Why is the country of origin using a different type of vaccine than everywhere else? Surely this is making a difference that might be actionable. If the rest of the world is exposed to something that causes internal or genetic differences that China does not have, could they not work on these differences as an attack vector for actual bioengineered weapons?

Phage, please stem my uninformed fears with your soothing information.

"There is no off switch" = the dreaded cytokine storm.
This is the primary issue with the mRna jab though there may well be others.

I choose not to live my life in fear.

If you are unaware of who Professor/Dr Mike Yeadon is, then please familiarise yourself with him and have a listen to his interview.
www.facebook.com...

Rainbows
Jane

a reply to: Phage

Phage, Phage, Phage...

Don't you get tired of being wrong all the time?...

...
Following a new collaboration between UiO and research groups in Nottingham and Oxford, it has now been revealed that RNA has a direct effect on DNA stability, according to Professor Klungland's research.

He believes the discovery will provide the health service with an important tool, since many studies have shown that the regulation of modifications to RNA is important for the development of cancer.

If genes that are important for the chemical compound 6-methyladenine are completely removed, this results in neurodegeneration in both mice and humans.

Where and how

In areas of DNA where RNA binds to one of the DNA threads in such a way that the complementary DNA thread becomes the sole thread (R-loop structures), the DNA stability will change if RNA is chemically modified by m6A.
...

Modified RNA has a direct effect on DNA

BTW, does anyone remembers that Faucci et al are calling for more doses every 6-12 months or so?...

Ironically the severity and the rate of adverse events is higher in the second dose than on the first. Can anyone state what this would mean if we have not 3 but several other doses as the fake Faucci et al are calling for?...




www.uphs.upenn.edu...

a reply to: ElectricUniverse

Yo idn't RNA and mRNA two diff thangs tho?

originally posted by: Archivalist
a reply to: ElectricUniverse

Yo idn't RNA and mRNA two diff thangs tho?

January 29, 2020
Modified RNA has a direct effect on DNA

by Eyrun Thune, University of Oslo
...
Important modification

The most common modification is on mRNA is 6-metyladenin (m6A). It has now been shown that this modification is essential for the survival of cells and model (non-human) organisms.
...

phys.org...

What I'm hearing from some in this thread is that the presence/effectiveness of the mRNA protein spike is not lasting (i.e. mRNA has a short half-life). Couple that with comments from Pfizer that a booster shot will likely be needed withing 12 months of vaccination.

So I'm trying to reconcile, then, with the 'evidence' posted in this thread that not only is the immune protection provided by the vaccines long-term, it may even be life-long (!!!)

From ABC News article

A report out last month from Pfizer suggests people who get both doses keep strong immunity for at least six months. Experts have been at pains to point out that doesn't mean immunity stops at six months. It means that's the longest volunteers in the trials have been followed to see what their immunity is. It's likely to last much longer, Hensley said.

"I would not be surprised if we learned a year from now that these vaccines are still producing a strong immune response," Hensley told CNN.

"I would not be surprised if this is a vaccine that we only get once."

That would make the vaccine more akin to vaccines against measles than flu vaccines. Vaccination against measles protects against infection for life in 96% of people.

So who are the ones spreading incorrect information here?

NBC News or ABC/CNN?

"Dr Scott Hensley" or Pfizer?

They are putting our conflicting narratives.

I wouldn't be having this 'vaccine' if you're having sex or thinking of breeding.
I see that abstinence or contraception was part of the Pfizer trail.
I wonder why?
Check page 132-135 of the pdf clinical protocol of Pfizer.

media.tghn.org...

a reply to: ElectricUniverse

Modified RNA has a direct effect on DNA

Sure, if it enters the nucleus it can do so. That's how retroviruses work, actually. But the mRNA from the vaccines doesn't enter the nucleus.

You're late, btw:
www.abovetopsecret.com...

Ironically the severity and the rate of adverse events is higher in the second dose than on the first.

For some perhaps. Not for me. Not for anyone else I know.