FDA Approves First Covid Vaccine

| August 23, 2021

It was just a matter of time. Today, the U.S. Food and Drug Administration approved the first Covid-19 vaccine. The vaccine is from Pfizer-BioNTech, and will be marketed as Comirnaty. The approval is for individuals 16 years of age and older. The vaccine will continues to be covered under the existing Emergency Use Authorization (EUA) for individuals 12 through 15 years of age, and for the administration of a third dose in certain individuals.

AW1 Rod sends.

US Drug Regulators Approve Pfizer’s COVID-19 Vaccine

By Zachary Stieber

U.S. drug regulators on Monday approved the COVID-19 vaccine from Pfizer and BioNTech for people 16 and older, making it the first such shot to receive approval in the country.

The Food and Drug Administration (FDA) said the vaccine, which will be known as Comirnaty, proved effective in a clinical trial of approximately 44,000 people.

The shot was 91 percent effective in preventing COVID-19 infection, regulators said, and was also effective in preventing severe disease and hospitalization.

The trial is ongoing in centers in six different countries, including the United States, and the data cited was accrued through March 13. Participants received either two doses of Pfizer’s jab or a placebo.

FDA officials said they also reviewed safety data and determined the vaccine’s known and potential benefits outweigh its known and potential risks, including side effects.

Mandatory vaccines for the military will be enacted very soon. Expect more mandates from the usual suspects, too. Wether to vax or not should be an informed decision between the individual and his or her health care professional, not used as entry criteria to restaurants.

The Epoch Times

Thanks, Rod

Category: COVID-19, Guest Link, Health Care debate

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Sparks

Money is a coming and money is a goin.

Watch the pockets.

UpNorth

There’s absolutely no chance that this approval is politically motivated. No way.

Mason

Right. What’s the rush? It’s getting widespread use under the EUA. The only thing this is good for is that peoples’ “out” that it wasn’t a fully approved vaccine is gone. There’s no scientific reason why this couldn’t wait the typical timeframe for full approval.

According to Johns Hopkins we’re at Phase III, which usually lasts about two years to ensure there are no long term negatives. https://coronavirus.jhu.edu/vaccines/timeline

Why push it to “Approved” after less than a year if the normal timeline is 2-4 years? This is apparently the only government regulation the Biden Admin is ok with removing.

The Other Whitey

Pedo Joe is unlikely to reach 2022, much less 2024. Next up is Whorris, the least-liked dem candidate in living memory (even Das Hildabeast has more fans! ), who will only sink their claims of legitimacy deeper.

I don’t know what the endgame will look like, but I doubt it will be clean, pretty, or bloodless. They’re trying to get this in ahead of that.

11B-Mailclerk

Hm. Harris will need a Veep to “unify” folks.

Hillary Clinton, perhaps.

Who else would someone as politically clueless as Harris pick?

I suspect the 2022 Senate races will see more shenanigans and weirdness, especially last-minute “emergency” measures, than the 2020 presidential vote.

They have to. Otherwise, they get skunked.

The Other Whitey

They’re smearing Larry Elder like crazy in the CA recall race. They seem to be scared absolutely shitless of a successful black dude who doesn’t drink the dem koolaid.

11B-Mailclerk

If they had run a popular Donk as a replacement, Elder would likely not be a threat.

Oops.

Berliner

With Hildabeast as a possible VP, Heels Up would always be wary. There “might” exist a possibility of Arkancide in the Oval Orifice.

LC

The very link you posted notes that accelerated development in a pandemic is 1-2 years. One of President Trump’s signature achievements, with bipartisan support, was Operation Warp Speed which was wholly designed to speed up development in a $10B public-private partnership. If that didn’t speed things up, was it a bust? A bad decision by then-President Trump? Or was it a success, and amazingly, $10B in funds to facilitate concurrent trials, pre-trial production, etc, was effective?

Also, the Pfizer drug saw its first trials in Americans in July 2020 – over a year ago, not less.

There’s no scientific reason why this couldn’t wait the typical timeframe for full approval.

The science isn’t dictated by the <time, it’s by the data. There is obviously a small indirect effect of time on data, but ultimately, advanced bioinformatics is capable of collecting and providing much more data than it could even just five years ago. I’d wager the FDA had more data to review now than they did an any non-expedited review just a few years back.

Again, was Trump’s “Operation Warp Speed” a success or not? It’s whole purpose was to get things out faster. Seems it succeeded, to me. Bravo, Trump. You don’t hear that often from me!

Mason

You cannot, by definition, know long term risks/benefits in such a short time.

Yes, the link said the time frames can be shortened. Obviously in this case they were. There’s a lot of risk involved in that. Why compound the risk with a premature full approval?

I’m certainly not saying the vaccine is unsafe, I’ve been pricked. I just question the wisdom in saying, after less than a year, that this is good to go.

The Dead Man

Chief, the reason vaccines go through such a long period is because there are long term effects you can’t account for no matter how many people you’re Mengele’ing in the name of science. The fact that the maker of mRNA vaccines is concerned and there’s valid concern to both side effects AND that the Pfizer jab is a therapeutic, NOT a vaccine for a disease with a 99.98% chance of survival for the majority of the population should be flagging even your red flags.

11B-Mailclerk

Only way to get long-term data is long-term use.

Only way to get data on a broad selection of the population broad population use.

At some point, you say “seems OK”, and people choose. This is -not- supposed to be coerced.

-not-

I generally get whatever shots my trusted medicos recommend. So far, they have kept me in reasonably good health, despite some major complications.

gitarcarver

LC, Where to begin? Pfizer did not take development money from Operation Warp Speed. What they did take was orders for the vaccine if found to be effective. There was a pot ‘o gold at the end of the development for them. Those orders were paid for up front. Moderna did take both development and money for orders. Secondly, Pfizer announced a Class III trial in July of 2020, but did not have the number of people it stated it needed until January, 2021. By then, the FDA had given Emergency Use Authority (EUA) in December of 2020, which is at least a month before Pfizer had the prerequisite number of people in their trial. The Pfizer and Moderna rMNA has had mild side effects which the CDC and FDA say is “normal” for a vaccine. However, given that this is the first time rMNA vaccines have ever been used to this scale by the public, and the continued lying to the general public about COVID, the vaccine, etc. it is not ridiculous to expect skepticism on behalf of people given no long term data. For the Pfizer and Moderna vaccine, “there has been an increase in reported cases of myocarditis and pericarditis after mRNA COVID-19 vaccination, particularly in male adolescents and young adults age 16 and older.” The Janssen/Johnson & Johnson COVID-19 vaccine attacks the virus in a different manner than the Pfizer and Moderna vaccine, but those side effects seem to be harsher and more severe. Side effects which may require emergency care include: Shortness of breath Persistent stomach pain Severe or persistent headaches or blurred vision Chest pain Leg swelling Easy bruising or tiny red spots on the skin beyond the injection site. In addition, there have been cases of Guillain-Barre syndrome after getting the Janssen/Johnson & Johnson COVID-19 vaccine. The Mayo Clinic recommends that individuals seek immediate medical care if you have weakness or tingling sensations, difficulty walking, difficulty with facial movements, double vision, and difficulty with bladder control. As you can seem, there are side effects of great consequence from the vaccines. Was Operation Warp… Read more »

USMC Steve

Well, how about this then chief. Typically, the FDA takes nearly a DECADE of research, which they charge the drug maker for a good chunk of, before a drug gets the approval.

USMCMSgt (Ret)

My guess is there are quite a few Senators and Congresspeople who have bought stock in Pfiser and make big $$$ off this.

Well, there’s that and the usual grifting of the American people.

Sparks

No way UpNorth! This has nothing to do with getting the media away from Afghanistan.

UpNorth

Of course, don’t look to your right, look over to your left at that vaccine.

Commissar

If it was politically motivated it would have happened months ago, nitwit.

Even the broader medical community was wondering why it was taking so long given the number of studies and number of people already vaccinated with extensive data on side effects across hundreds of millions of doses and administered,.

The Dead Man

Finally got your paycheck Lars? So do they give you your talking points along with the paycheck or have you been sleeping on the job?

Jeff LPH 3, 63-66

Pfizer used to be located in Brooklyn NY then moved to NJ. We used to pick up 500 LB bales of MaryJane (grass)from cargo ships at the Port Authority Piers in Red Hook Brooklyn, NY and bring them in a truck convoy to Pfizer in NJ and sometimes the stuff came into JFK Aerport. Off Topic but I typed in a little trivia from back in the day.

FuzeVT

Comirnaty? If the product you are wanting to market has a name that people look at, say it a few different ways and then are unsure what it’s supposed to sound like afterward – you may just be an idiot.

Wu-Flu-B-Gon would be much better.

Mason

They really should have just given the nod to the Trump and called it Covfefe.

Sparks

Wu-Flu-B-Gon

LMAO. I needed that this morning Brother.

Poetrooper

Spot on, Mason. Take a bow…😜😜😜

ChipNASA

I’ll be pushing and shoving to get in front of you fucktards for the new vaccine and I bet there would be lines longer than the WWII enlistment lines if you have a jab that is called “Commissaradicate”
Where’s my 401K???
😀 😀 😀

Sparks

From China:

“Don’t worry about COVID 19 problems, because we have the COVID 22 Millenial Edition on the way”.

/sarc/

FuzeVT

Only the most useful and well engineered things have “ME”™ in the product name.

Sparks

Yes, I remember how many clowns I tried to get to not buy ME when it came out. But, they bought into the Microsoft “newer is better” hype.

FuzeVT

Sigh – I was one of those who bought it. In my defense, the most recent computer m y wife and I had used was a hand me down from her dad’s office running Windows 3.1.
That was our first computer we purchased as a married couple (and the first time with “internet”!) Dial up Earthlink was the domb diggedy yo. There was just the issue with this crappy operating system. . . .

FuzeVT

That should be “bomb”, of course. Drew the ‘b’ backwards.

NDHoosier

There’s a reason it was called Windows Mistake Edition

Anonymous

And don’t forget…

FuzeVT

I’m glad I live in a world where I can call that up on YouTube any time I want.

AW1 Rod

And now, everyone who’s been vaccinated will require “boosters!”

It’s quite obvious we’ve been sold a Bill of Goods by the government and Big Pharma, who are making money hand-over-fist in this arrangement. A sweet deal for them. And the government likes it, too, as it allows them to continue their fear-mongering and to restrict/control the sheeple’s lives.

Mason

Great big signs at every Wal-Mart, Target, and pharmacy in the country “No Cost COVID Vaccine Available Here*”

*They will bill any fees to your insurance or the government will pay the bill for the uninsured.

Someone’s paying for all this. Developing, distributing, and administering vaccines isn’t free.

USMC Steve

WE ALL ARE. Well those of us who work and pay taxes and such.

The Other Whitey

They have been sufficiently stroked, bribed, and/or blackmailed into approving an experimental process with zero testing for long-term efficacy and side effects—and whose own inventor is warning people that it is not safe—, but are campaigning to discourage people from using medications that have been established and vetted for decades.

Seems legit!

KoB

Surprised that the FDA waited this long after the coronation of prezzy sniffy to rubber stamp this approval. Guess they had to at least make it look legit.

Is the Big Guy getting his 10%?

Jay

“Well, now that it has FDA approval…im sure the vaccine hesitant will be SURE to get it!”….said no one ever.

26Limabeans

I’ll wait for FCC approval.

Poetrooper

Lars and LC showing up here to tell us this approval was done legitimately and scientifically in:

3…2…1…

Ol’ Poe just has one question: What if the Biden administration is as wrong about this vaccine as they have been about Afghanistan?

11B-Mailclerk

If Trump was in office, would we be as suspicious? He was the guy that got the paperwork slashed, and guaranteed payment so that they made industrial batches before approval.

I think folks who don’t like the US are feeding all sides a bunch of castor oil, so there is plenty of shit to stir.

Think about what happens next time, when some batshit/evil/stupid fool does “gain of function” on something more lethal. We will need to-do this again, and probably no more than a decade. ChiComCoof19 was a fuck. GoatPox2025 will be someone’s hate-mail.

Make your informed choices. Tune out the loud influencers. And understand the enemy plays both sides.

Poetrooper

“…they played the Pandemic card a bit too well.”

And they are pushing the vaccines way too hard, which is precisely what has folks like me suspicious of their motives.

If their defiant opposition to the vaccines when Trump was president was purely political, then doesn’t it stand to reason that totally reversing their position when they are in power may be equally insincere and politically self-serving?

The Democrats are reaping the seeds of distrust that they have long sown with their blatant and continuous dishonesty and hypocrisy. At this very moment, the Biden administration has been caught lying to us to cover up their incompetence in Afghanistan.

Are we then to believe that this is the only issue about which they are lying? That they are forthright and sincere about everything else? That the gross incompetence they have shown in foreign affairs doesn’t extend to their blundering handling of the Covid pandemic and the vaccines?

By their own actions they have discouraged trust and cooperation. Every single thing Democrats try to do should be met with suspicion and skepticism.

And in ol’ Poe’s case, it is…

11B-Mailclerk

I am trying to limit my intake medical advice to medical pros I trust. Works pretty good so far.

The internet is crawling with stockyard-quantities of bullshit. All sides.

Mason

I would still be suspicious. Our regulatory agencies move at a glacial pace. In the case of the FDA, that’s a feature not a bug.

The Dead Man

He got booed recently at rally for pushing the vaccine.

Supposedly there’s an attenuated, actual no-shit vaccine, not a therapeutic coming soon. I’ll wait for that on the off chance I feel I need one.

OldManchu

Lars can have my vaccine and stick it straight up his ass.

Anonymous

He’ll want it dick shaped/sized.

Mason

What if the Biden administration is as wrong about this vaccine as they have been about Afghanistan EVERYTHING?

FTFY, Poe.

USMC Steve

The only thing that Resident Xiden has been consistently is being wrong, and he is batting 1000 on that.

Poetrooper

Actually, I have one more question: If the government has now deemed this vaccine safe will Pfizer no longer have total immunity for both short and long-term deaths and damages occurring from its use?

11B-Mailclerk

I think Congress has to do that. And I would think it a very good idea.

Sparks

From China:

“Don’t worry about COVID 19 problems, because we have the COVID 22 Millenial Edition on the way”.

/sarc/

Roh-Dog

I don’t think the rabble here completely understand the unique and disparate situation in which we find ourselves. It’s time that we contact our Representatives, Senators and any other agent of the system to suggest a “whole of government approach” to this novel situation. This program I propose will require an ‘All-hands’ to make sure this organized response is 100% successful:
-All gov employees
-all vaxxx facilitators
-any citizen that believes in medical tyranny
Are to line up on the Main Street of their respective home towns at noon(local), on their knees, so I can come by unpanted, whereupon presentation of my 4th point of contact, they can pucker the fk up and KISS MY ASS!
Not no but fk no, I ain’t taking it.

Milo Mindbender

I read the paperwork releases today, it only renews the EAU the way I read it didn’t see anything saying that it was now approved for general useage
It smells like a snow job, spread by the ass clowns on the airwaves.

Quartermaster

The “approval” is illegal. tests for safety and efficacy were not done. The control group was disbanded. The FDA did not hold the mandatory hearings.

This is a lawsuit waiting to happen. The vaccines are still fake and are certainly not safe or effective.

alligatorcrocodilesame

I never planned on taking it regardless.

And still won’t take it.

Why do we need a drug for something which kills less than 2% of the entire world population? Which has gradually less efficacy and requires ‘boosters’, and which greatly increases my chances of dying from a cardiac arrest, blood clot, or other adverse reaction…

Sorry but not sorry, I will die to uphold my and my children’s individual liberties, Big G and its pals gonna have to suck it.

Besides, if the ‘pandemic’ was ever an issue why are we importing people from notoriously diseased and filthy third world countries at an unprecedented rate???

Commie-Tsar

IT’S TEH COVID, PROLES!!!! PUT YOUR FACE DIAPERS BACK ON AND HUNKER DOWN!!!! GO GET THE JAB AND PUT ON 10 MASKS!!! I HAVE MY EMPIRIC DATA TO SHOW YOU THAT YOU’RE TRYING TO MAKE ME SICK!!! I MASK UP WHEN I POST HERE TO KEEP FROM GETTING SICK!!!

Roh-Dog

Why don’t you with that mess of a addagashtome get the hell on an aircraft and fly to Asstrashistan so you have to wear a mask for the rest of your self-identifying as a otherkin existence?
Your state worship has gotten old.

A Proud Infidel®™

He’s just a sockpuppet spoofing our babbling moonbat from UC Berzerkely!

Roh-Dog

…………..!?!
no way

Poetrooper

An article at American Thinker led me to this report on Marek’s Disease a viral infection of chickens that can be prevented with a vaccine, but that then leads to an ever more dangerous and lethal virus.

https://www.pbs.org/newshour/science/tthis-chicken-vaccine-makes-virus-dangerous

https://www.americanthinker.com/blog/2021/08/to_understand_the_covid_vaccine_and_the_delta_variant_check_out_the_chickens.html

Tallywhagger

I do not approve of the FDA and am having no part of their pernicious social experiment.

Any damned government that mandates the debaucheries put forth over the past nearly two years, which measures have accomplished nothing, has no credibility, should be relieved of their authority, and held accountable for their wanton dereliction and frivolous caprice.

Sapper3307

Nope!

Poetrooper

From the Truth. Based. Media. website:

“Data released Friday by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Aug. 13, 2021, a total of 326,535 adverse events had been reported to the Vaccine Adverse Events Reporting System (VAERS) attributed to Pfizer’s COVID vaccine, including 9,027 deaths and 56,607 serious injuries.”

I tried to go directly to the CDC site but it won’t open. No surprise when they have this many adverse reports. There’s never been any drug or vaccine approved by the FDA with those kinds of numbers.

11B-Mailclerk

“Adverse event” is not a cause/effect determination. That comes later.

Dying in a traffic accident is a reportable event (death).

If you tell the doc you got a bad case of dandruff a week after an injection, that is a reportable event. So is a spouse getting pregnant.

People rarely report upset stomach after ingesting aspirin. They often report every imaginable thing after something novel.

Don’t over-read the vaers stuff. If you gave everyone in the country a small wooden tablet to swallow, there would be all sorts of odd events that would be reportable.

Cause/effect is -not- determined at the “Adverse event” reportable point. That comes later.

If someone dies of a heart attack, and the person has a positive test for Covid, did they die of Covid?

No?

If someone dies of a heart attack, and the person has a recent vaccine, did they die of vaccine?

No?

Both cases, insufficient data.

Note: case 2 is a reportable adverse event. Without and before cause is evaluated. (“Severe adverse event”)

The vaers system data is being misused by folks who either do not understand it, or who think you do not understand it.

Don’t take my word for it. I only have to complete AER training annually. Go make an appointment with your trusted doc to explain “adverse event reporting” and the vaers system data, and that “data” isn’t even “correlation” , nor anywhere near “causation” .

If you don’t actually understand the available information, you cannot make an informed decision.

Do, or do not. Free country. But please don’t make critical medical decisions based on rumor and some internet Randos.

Jay

Causation does equal correlation, but in some cases it is HIGHLY SUGGESTIVE. When you have relatively healthy people having heart attacks (aged 19-35) days after receiving the jab, and NOTHING ELSE is suspect about their lives….it’s suspicious.

I don’t put much credence in the 90 year old who died 3 months after receiving the jab. Just like I don’t put too much confidence in the fact that John Glenn’s widow died at the age of 101. Of Covid.

Jay

*does NOT

Anonymous

BOHICA!

Anonymous

Although this would probably be better to consider:

Sapper3307