Pfizer-BioNTech Coronavirus Vaccine Wins Full FDA Approval, Potentially Persuading The Hesitant To Get A Shot

[Canon Shooter]

Safe - not true.

" If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use."

"FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. "

You trust pharma companies that much?

The many ways FDA is responsible for protecting the public health.

The many ways FDA is responsible for protecting the public health.

www.fda.gov

So, I take it you're not getting vaccinated?

 

[Jimmy_Chitwood]

Odd.

So, if you have some ailment, and one pill will fix you right up and is approved by the FDA, and another pill will fix you right up but isn't approved, which one are you choosing, and why?

I think my response was not clear.

I was saying FDA approval is importnat.

Sorry.

 

[Jimmy_Chitwood]

So, I take it you're not getting vaccinated?

Maybe.

Letting the lab rats do their work.

 

[Crepitus]

This is very good news.

The Pfizer has full approval from the FDA. It's no longer being distributed on emergency basis.

Hopefully this will help more people to get protected.

Pfizer-BioNTech coronavirus vaccine gets full FDA approval, potentially persuading the hesitant to get a shot

Opens the way for mandates, and the republicans will have to get vaccinated whether they want to or not.

 

[Crepitus]

PHDs are the most resistant group - good luck!

Stop repeating that lie please.

 

[Dana7360]

Opens the way for mandates, and the republicans will have to get vaccinated whether they want to or not.

I don't like mandates. I never have.

My choice is that everyone gets vaccinated so that mandates are not necessary.

Unfortunately the republicans are making that impossible.

So the mandates will continue to happen and will happen faster.

 

[marvin martian]

This is a lie.

A woman by the name of Francis Oldham Kelsey single handedly prevented the FDA from approving thalidomide.

The FDA NEVER approved Thalidomide.

Frances Oldham Kelsey - Wikipedia

en.wikipedia.org

Frances Kathleen Oldham Kelsey, CM (July 24, 1914 – August 7, 2015) was a Canadian-American[1]pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety.[2] Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service, awarded to her by John F. Kennedy in 1962.

Here it is right on the FDA's website, you rube.

Thalidomide (marketed as Thalomid) Information

www.fda.gov

 

[Rogue AI]

No.

I think it better than not being approved.

A level of vetting.


Very important to many.

FDA approval is just peachy for folks that already trust everything the government tells them. Folks with reason to doubt won't be so easily swayed. If doubt remains it's likely due to CDC's ever changing guidelines.

 

[Dana7360]

Here it is right on the FDA's website, you rube.

Thalidomide (marketed as Thalomid) Information

www.fda.gov

I stand corrected.

It was approve on a very limited basis in 1975. But at that time it was only allowed to be used for one condition, leprocy. Nothing else.

In 1998 it was approved for some cancer chemo conditions.

That's it. Nothing else.

It's very highly regulated and classified at the most severest rating, Category X.

It's approved for marketing. I am not sure how that is different from full approval. But it's highly regulated and wasn't approved at first. In fact many laws were passed because of the effects of it on pregnant women.

It took decades for the FDA to approve it and only for marketing. The FDA made sure that it was safe before it was allowed to be prescribed in the United States.

From your link:

US Regulatory Response to Thalidomide (1950-2000) | Embryo Project Encyclopedia

Thalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug...

embryo.asu.edu

The FDA allowed marketing of thalidomide by Celgene Inc., a New Jersey pharmaceutical company on 16 July 1998. Together, Celgene and the FDA developed the System for Thalidomide Education and Prescribing Safety (STEPS) program. This program required registration by physicians who prescribed thalidomide, as well as their patients. The program also insisted on a number of contraceptive measures such as proof of an initial negative pregnancy test prior to treatment, proof that the patient was using two forms of contraception, and submission of monthly pregnancy tests. The FDA placed Thalidomide under Category X of the FDA's pregnancy ratings, categories created in 1975 for pharmaceutical companies to label medications according to their affects on reproduction. The fifth and most severe rating, Category X, is for drugs that empirically contribute to fetal deformities, and for drugs whose risks or undesired effects outweigh possible benefits to the patient. This pregnancy rating and the STEPS program later served as a foundation for the FDA's response to isotretinoin (Accutane), a prescription drug used to treat severe acne. Like thalidomide, isotretinoin caused severe birth defects and prompted its manufacturer and the FDA to create a risk management program to prevent fetal exposure.

In July 1998, the FDA approved the marketing of thalidomide, and today the drug is used to treat inflammation associated with leprosy and also acts as a chemotherapeutic agent for patients with cancer of the plasma cells in bone marrow (multiple myeloma). Thalidomide is available through the US Public Health Service Commissioned Corps, headquartered in Washington, DC.

 

[fncceo]

A politically-motivated FDA approval isn't going to change my decision.

 

[Adrenochrome Junkie]

I got the Pfizer. I'm glad it has full approval now.

When the third shot becomes available I'll get it.

And the forth fifth sixth seventh…

 

[Rigby5]

So?

You and millions of other Americans have taken other medications that went through the exact same process.

No one had any problem with other drugs going through that process.

What's the problem with the covid vaccine going through it?

Wrong.
Thousands of FDA approved drugs or treatments have gone wrong, caused problems, etc. like Thalidomide.
I took the vax anyway, but no one can say they are not risky.
Its not like they are using normal vaccine methodology.
They do not contain dead virus.
Instead they only contain a synthetic spike protein.
That is very risky since our own exosomes also use that same spike protein.
No one can be sure if these vaccines are setting up future deadly autoimmune responses or not.

 

[Rigby5]

Odd.

So, if you have some ailment, and one pill will fix you right up and is approved by the FDA, and another pill will fix you right up but isn't approved, which one are you choosing, and why?

All pills have risks.
But the FDA is supposed to do enough testing to give some sort of degree of risk.
Without FDA approval, its a total unknown.

 

[Rigby5]

And the forth fifth sixth seventh…

Good point.
Since the vax only has a synthetic spike protein, it likely will lost effectiveness with time and variants.

 

[colfax_m]

Wrong.
Thousands of FDA approved drugs or treatments have gone wrong, caused problems, etc. like Thalidomide.
I took the vax anyway, but no one can say they are not risky.
Its not like they are using normal vaccine methodology.
They do not contain dead virus.
Instead they only contain a synthetic spike protein.
That is very risky since our own exosomes also use that same spike protein.
No one can be sure if these vaccines are setting up future deadly autoimmune responses or not.

The other poster is correct.

Thalidomide's problem was that it was a teratogen and that it was attempting to be prescribed for morning sickness. The FDA never approved it for this indication and therefore is not at fault for doing something that caused problems in other countries.

Thalidomide is used primarily in multiple myeloma but you have to jump through a lot of hurdles to prescribe it, although most people use a similar drug lenalinomide instead.

 

[Dana7360]

And the forth fifth sixth seventh…

So what? What's your point? That the FDA wants to make sure we are safe from the virus? Yes, I'll agree with that.

More than half of the people in the United States does exactly that for the flu every year like clockwork.

Including me.

I'll get my yearly flu vaccine in the fall. Just like over half of the people in our nation. I hope you will.

 

[MinTrut]

Stop repeating that lie please.

PhD holders are massively hesitant; this is a fact.

 

[whitehall]

What was the holdup on the approval? Too many fatalities?

 

[Dana7360]

Wrong.
Thousands of FDA approved drugs or treatments have gone wrong, caused problems, etc. like Thalidomide.
I took the vax anyway, but no one can say they are not risky.
Its not like they are using normal vaccine methodology.
They do not contain dead virus.
Instead they only contain a synthetic spike protein.
That is very risky since our own exosomes also use that same spike protein.
No one can be sure if these vaccines are setting up future deadly autoimmune responses or not.

Thalidomide wasn't approve in the United States until 1975. It was denied approval for decades.

In 1975 it was approved for ONE condition. Leprocy.

In 1998 one more condition was added. Some cancer patients on certain chemo.

That's all.

No one else can ever get that drug in the United States.

It's on the highest severity rating, Category X.

It's very highly and strictly regulated with both doctor and patients having to register with the government and females of child bearing years have to prove they aren't pregnant when starting the drug, must be using 2 forms of birth control and must have a negative pregnancy test every month.

It wasn't approved in the United States when it was causing birth defects. As a result there was 17 reported births with defects caused by the drug. It wasn't regulated and it was allowed in Europe which is how some women in the United States was able to ge the drug at that time.

The FDA prevented the catastrophe of birth defects from happening here in the United States that countries in Europe had at the time.

The story of Thalidomide is a very good example of the FDA doing what's right and keeping Americans safe.

You should have done some research before you used Thalidomide as an example. It's not. In fact it is an example of how you're so very wrong.

 

[marvin martian]

What was the holdup on the approval? Too many fatalities?

Not enough bribes.