Full FDA Authorization Of Vaccines

Life is a risk.

There are no guarantees that when you arise, whether you will make it through the day alive, or that this might be your last day of life on Earth.

No guarantees. Especially if you drive on public roads.

It is a matter of constantly choosing what appears to be the least risk.

We don't know if there are going to be long-term side effects from the vaccine.

But we do know that this virus is killing people.

The vaccine odds currently appear way better than the no vaccine odds.

That's why the FDA is motivated to do the best job they can of vetting the relatively new vaccines.

It's a good thing we have the vaccines. They are our best weapon against COVID.

One of the things the FDA did besides going over all of the data and formulas, was to physically go and inspect the production facilities and the process to manufacture the vaccine. Making sure nothing is overlooked. Making sure of the highest quality possible.

That lends further confidence in the fully approved vaccine.
 
Polibullshitter is an extremely pompous, arrogant, boorish, hectoring twat. She said that she liked to go on cruises, can you imagine being stuck on the same table as that dullard?
No I cannot. People have probably jumped overboard from being bored out of their minds by her.
 
Long term side effects from vaccines are extremely rare, any effects tend to show up in the first two months after being vaccinated.

How Do We Know the COVID-19 Vaccine Won’t Have Long-Term Side Effects?


One of the reasons some people haven’t signed up to receive the COVID-19 vaccine is that they’re worried there might be unknown side effects that will show up months or years later.

Although it’s true there are still a lot of things we’re learning about the vaccines — like how effective they are against variants and how long their protection lasts — there are plenty of things we do know that give experts confidence in the long-term safety of the vaccines.

History tells us that severe side effects are extremely rare, and if they do occur, they usually happen within the first two months.

The most recent example of this phenomenon is the Johnson & Johnson COVID-19 vaccine. The vaccine was put on pause when health officials learned that a small number of people who received the vaccine experienced a serious blood clotting problem.

About 7.4 million Americans had received the Johnson & Johnson vaccine when regulators paused its administration to investigate a handful of cases in which people had blood clots. All of the cases emerged within two weeks of vaccination.

Upon reviewing information about the cases, federal health officials determined that the benefits of the vaccine outweighed the risk, and they approved resumed use of the vaccine.

This is how the system is designed to work if unexpected side effects emerge.

History shows this is a common pattern. When new vaccines are released, the unknown side effects, if any, show up within two months of vaccination. This history goes back to at least the 1960s with the oral polio vaccine and examples continue through today.

Because of this, scientists and public health officials continually monitor vaccine data before, during and after a vaccine becomes available to the public.

COVID-19 vaccine technologies have been studied for years and used in other treatments without issue.

mRNA vaccines. The vaccines made by Moderna and Pfizer-BioNTech use messenger RNA, or mRNA, to deliver a message to your immune system with instructions on how to fight the coronavirus infection.

Researchers have been studying and working with mRNA vaccines for decades. mRNA vaccines have been studied before for influenza, Zika and rabies. Beyond vaccines, cancer research has used mRNA to trigger the immune system to target specific cancer cells. Learn more about how mRNA vaccines work.

Adenovector vaccines. Viral vector vaccines use a modified version of a different virus (the vector) to deliver instructions that teach cells how to fight the coronavirus infection. In the case of the COVID-19 case, it’s the adenovirus, a common virus that causes colds or flu-like symptoms. However, the adenovirus was modified so it can enter cells but can’t replicate or cause illness.

Scientists began creating viral vectors in the 1970s, and they have been studied for gene therapy and cancer treatment. Some vaccines recently used for Ebola outbreaks have used viral vector technology, and studies have focused on viral vector vaccines against other infectious diseases such as Zika, influenza and HIV. Learn more about how the Johnson & Johnson vaccine works.

The vaccine development process, from clinical trials to ongoing monitoring, helps to uncover and understand side effects.

Clinical trials are a key part of vaccine development and involve evaluating use in tens of thousands of study participants. All of the COVID-19 vaccines went through this rigorous process before authorization.

In reviewing results from the trials, the federal Food and Drug Administration must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.

After vaccines are authorized and in use by the public, public health officials continue monitoring the data as an additional safety measure. Manufacturers must have a plan to report follow-up data, including any events such as hospitalizations and deaths, and they must continue research to generate more data on safety and efficacy. Learn more about FDA emergency use authorization

https://www.uab.edu/reporter/resour...-3-things-to-know#vaccines_eliminated_quickly

therefore the anti vaxers take no drugs. You never know what can happen in a decade or 2 on any drug.
 
I’ve taken a flu shot every year for over 15 years, no long term side effects. I get my other vaccinations every ten years, no long term effects.
Those "other vaccinations" were researched and studied for years if not decades prior to being released. Not mere months. There has never been an vaccine like this brought to market.

The long term effects, remain to be seen. That is a fact.
 
Life is a risk.

There are no guarantees that when you arise, whether you will make it through the day alive, or that this might be your last day of life on Earth.

No guarantees. Especially if you drive on public roads.

It is a matter of constantly choosing what appears to be the least risk.

We don't know if there are going to be long-term side effects from the vaccine.

But we do know that this virus is killing people.

The vaccine odds currently appear way better than the no vaccine odds.

That's why the FDA is motivated to do the best job they can of vetting the relatively new vaccines.

It's a good thing we have the vaccines. They are our best weapon against COVID.

One of the things the FDA did besides going over all of the data and formulas, was to physically go and inspect the production facilities and the process to manufacture the vaccine. Making sure nothing is overlooked. Making sure of the highest quality possible.

That lends further confidence in the fully approved vaccine.
:
What a load of generalized, supposition and conjecture laden baloney!Less than a year of proper testing/clinical trials does not equate with being "full approved".
If this is the quality of smoke Covid vaccine justification folk blow up each others keisters, then we as a country (if not the world) are in for some rough times in the not-too-distant future. https://www.justplainpolitics.com/s...thorization-Of-Vaccines&p=4623541#post4623541
 
Hello Taichiliberal,

:
What a load of generalized, supposition and conjecture laden baloney!Less than a year of proper testing/clinical trials does not equate with being "full approved".
If this is the quality of smoke Covid vaccine justification folk blow up each others keisters, then we as a country (if not the world) are in for some rough times in the not-too-distant future. https://www.justplainpolitics.com/s...thorization-Of-Vaccines&p=4623541#post4623541

Let's just review our situation.

Over 24,000 Americans are in Serious or Critical Condition.

Our hospitals are being overwhelmed. Many are full. Full hospitals are desperately trying to find other hospitals to take transferred patients because they have no room for them. Most COVID patients struggling for life in ICUs are unvaccinated.

Over 1,100 Americans died from COVID yesterday.

There were over 147,000 New Cases of COVID identified yesterday.

There are now over 7.7 Million Active Cases of COVID-19 in the USA. On this date last year there were about 2.5 Million Active Cases. We peaked at 9 Million Active Cases in January and, thanks to the vaccines, dropped to 5 Million in early July.

America is being beaten back by the bug.

We are unable to even hold ground against it.

Over 648,000 Americans have died of Corona. We will be over 650,000 Americans dead within days.

The vaccines are the only thing that stand between America and desolation.


Those who personally object to the vaccine owe a great debt of gratitude to the brave Americans who have volunteered their arms for the solution to this problem.

People who get the vaccine are braver than people who are afraid of it.

It is foolish to fear the unknown when a grave risk is posed by the known.
 
I’ve taken a flu shot every year for over 15 years, no long term side effects. I get my other vaccinations every ten years, no long term effects.

how long have those 'other' vaccinations been around, thoroughly tested and studied, modified and improved compared to the covid vaccines......especially after finding out that they don't stop covid, don't prevent the spread among vaccinated, and lose it's efficiency by half within 4 to 6 months and require a booster.............whose efficiency we are just now starting to almost learn??????
 
Hello Taichiliberal,



Let's just review our situation.

Over 24,000 Americans are in Serious or Critical Condition.

Our hospitals are being overwhelmed. Many are full. Full hospitals are desperately trying to find other hospitals to take transferred patients because they have no room for them. Most COVID patients struggling for life in ICUs are unvaccinated.

Over 1,100 Americans died from COVID yesterday.

There were over 147,000 New Cases of COVID identified yesterday.

There are now over 7.7 Million Active Cases of COVID-19 in the USA. On this date last year there were about 2.5 Million Active Cases. We peaked at 9 Million Active Cases in January and, thanks to the vaccines, dropped to 5 Million in early July.

America is being beaten back by the bug.

We are unable to even hold ground against it.

Over 648,000 Americans have died of Corona. We will be over 650,000 Americans dead within days.

The vaccines are the only thing that stand between America and desolation.


Those who personally object to the vaccine owe a great debt of gratitude to the brave Americans who have volunteered their arms for the solution to this problem.

People who get the vaccine are braver than people who are afraid of it.

It is foolish to fear the unknown when a grave risk is posed by the known.

Let me just pull the rug out from under your clap trap:


The Reliability of RT-PCR tests for COVID-19

https://www.randombio.com/rtpcr.html


Your Coronavirus Test is Positive. Maybe It Shouldn't Be.



https://medicine.yale.edu/labmed/se...Ct values_YNHH Aug. 2020 _395430_36854_v1.pdf


Guidelines to the writing of case studies


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2597880/


That's it. You've been reduced to regurgitating the SOS with a dose of near jingoistic blathering. Sad, as I expected better of you. See you in a month, PT.
 
One letter went to Pfizer which is still EUA because it still has the liability shield. ( https://www.fda.gov/media/150386/download )

The BioNtech vax is still in development, not ready for use yet and will be conditional until "fully approved" without a liability shield.
DHHS has issued a license to BioNTech (in Germany) controlling manufacture and sale of biological products. The license will then
authorize Pfizer to introduce or deliver for introduction into interstate commerce. That license will authorize them to manufacture
the product COVID-19Vaccine, MRNA. It will then be labeled by Pfizer as Comirnaty.

Also, the FDA completely bypassed the always necessary external advisory commissions with public comment period and unilaterally decided that there probably
wouldn't be any concerns that would have benefited from an advisory decision. Amazing. Sure. Nothing to see here. No questions. No cardio toxicity issues anywhere.
They just went ahead and authorized it. The only data they have is outdated because THIS Comirnaty is a brand new vax, not even on the market yet! Nothing in
there shows them dealing with the Delta variant. It's all about the original studies.

Plus the FDA letter only authorizes use for those 16 years of age and above. So, Deblasio needs to cool his jets on shooting up kids with this stuff. The studies
for kids won't be done until '23 or '24. Bet they'll probably shove another EUA out, this time for the kids.

The media and the pols have played a little shell game here and stated that the regular old Pfizer vax for EUA with its liability shield still in place
has the full formal approval. It does not. It will be the new one by the name of Comirnaty...in a couple years.

On page 6 they admit they do not have sufficient amount of data through VAERS system to determine risks properly. Unreal. But, they'll push it through.
They admit their system is inadequate, but again....so what. They'll just do what they want.
I see there that they at least acknowledge the myocardial issues and will require a 5 year follow-up.

They issued 2 separate letters for 2 separate vaccines.
The currant Pfizer still has the EUA classification and the liability shield. (no change) Pfizer always wants that liability shield.
The licensed BioNTech product, is similar, called Comirnaty, is not yet available until '23 or '24 and will not have a liability shield.

Nice bait and switch there lyin' fake state media! Show the public BOTH letters! Maybe just sloppy reporting and confused the two. LOL

https://www.fda.gov/media/151710/download
 
Hello Taichiliberal,

Let me just pull the rug out from under your clap trap:


The Reliability of RT-PCR tests for COVID-19

https://www.randombio.com/rtpcr.html


Your Coronavirus Test is Positive. Maybe It Shouldn't Be.



https://medicine.yale.edu/labmed/se...Ct values_YNHH Aug. 2020 _395430_36854_v1.pdf


Guidelines to the writing of case studies


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2597880/


That's it. You've been reduced to regurgitating the SOS with a dose of near jingoistic blathering. Sad, as I expected better of you. See you in a month, PT.

I have to hand it to you for maintaining decorum over something that you apparently feel so strong about that you're clinging to insignificant details. I appreciate the respect, and I'm glad to return it. I am perplexed at the number of times you've said you won't be commenting again for a month, only to be back at it just days later. My, but these are awfully short months!

The bottom line for me on the effectiveness of testing is how many people who test positive end up on a ventilator. We can talk about theory all we want, but the real world indicators conflict with your theory.

And look at how many people wonder if they have COVID, maybe they have some symptoms, they go get a test, they find out they are negative, their symptoms clear up, must have been something else. Most people who go get a COVID test get a negative result. All too many who test positive end up dead.

I know you've got very detailed articles and points of view suggesting the testing is not accurate, but the real world experience belies your argument.
 
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