The U.S. Food and Drug Administration issued its full approval Monday of the Pfizer-BioNTech COVID-19 vaccine, marking the first approval of a COVID vaccine outside of its emergency use authorization.
An FDA advisory panel issued the approval for people age 16 and up based on clinical trial and follow-up data on the vaccine’s effectiveness from roughly 20,000 vaccine and 20,000 placebo recipients age 16 and older.
The FDA also analyzed safety data from roughly 22,000 people who received the vaccine and 22,000 people who received a placebo. The trial data found that the vaccine was 91 percent effective at preventing COVID-19 disease, according to the FDA.
Acting FDA Commissioner Dr. Janet Woodcock called the approval a “milestone” in the ongoing pandemic.
“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” she said in a statement.
The Pfizer vaccine will now be marketed as Comirnaty, according to the FDA, and will continue to be available to people ages 12 to 15 under the FDA’s emergency use authorization.
The FDA is expected to issue a subsequent approval for the vaccine developed by Moderna in the coming weeks, while Johnson & Johnson is expected to apply soon for approval of the one-dose vaccine developed by its pharmaceutical subsidiary Janssen.
In California, state officials celebrated the Pfizer vaccine’s approval and urged people to get vaccinated if they have yet to do so to drastically reduce the likelihood of developing serious illness or dying from COVID-19.
“We know the vaccines work. We know vaccines are safe. We know they save lives,” California Department of Public Health Director and state Public Health Officer Dr. Tomas Aragon said in a statement. “If you are not vaccinated, let this be the milestone that gets you there.”
The FDA issued its original emergency use authorization for the Pfizer vaccine Dec. 11, 2020, for people age 16 and up. In May, it expanded that authorization to children ages 12 to 15.
While some 362 million vaccine doses have been administered in the U.S. and more than 200 million Americans have gotten at least one vaccine dose, state and local officials expressed optimism that the FDA’s full approval will spur more people to get vaccinated in the coming weeks.
“We hope this FDA approval removes another barrier for vaccine-hesitant members of our community to protect themselves and their loved ones,” Santa Cruz County Health Officer Dr. Gail Newel said. “The Delta variant is significantly impacting our unvaccinated population, and these vaccines, along with wearing face coverings in public, are the best tools we have to protect ourselves.”
In California, just over 46 million vaccine doses have been administered to roughly 25 million residents. Last week, FDA advisors and state officials also issued their respective approvals of booster vaccine doses for immunocompromised people who received the two-dose Pfizer and Moderna vaccines.
“I encourage all Californians to trust the science and protect themselves and their community by getting vaccinated,” Gov. Gavin Newsom said in a statement. “With more than 80 percent of Californians 18 and up having received at least one dose, our work continues to close the gap in our most impacted communities and bring an end to this pandemic.”
Time to roll up your sleeves, snowflakes.
https://www.fda.gov/media/150386/download
Document dated Monday August 23, 2021
Page 12, first paragraph:
This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older
The Pfizer vaccine is fully approved for people age 16 and over. The emergency approval status for people age 12 to 15 remains in effect pending receipt of further data.
@Ggoglar, from Page 2 of the FDA document you cited:
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
The next paragraph states that the FDA is also reissuing the EUA to cover uses other than what were included in the BLA (the full approval). 12 through 15 year olds can still get the vaccine through the EUA.
Page 2:
“On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter
of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses”
Basically they are leaving the previous authorizations in place in this letter because they are still valid. Pretty much they are just adding the new full authorization to the old letter. The section you quoted was from the old part of the letter.
Wow, you have really found the evidence haven’t you, this is the “re-issued” letter of EUA authorization. This is not the Approval letter, that can be found at https://www.fda.gov/media/151710/download. This is is the real BLA authorization….it is FULLY approved……
Trust PCR tests, trust true Covid death counts, trust vaccines that kill and injure people, trust masks, trust ventilators medical personnel don’t know how to use correctly, trust CDC, WHO? I don’t think so.
Love to see the deep state/ permanent government so desperately try and keep control of the narrative. They are losing control by the hour now. Take a look at Australia today. They finally decided to fight for their rights. Everything in an effort to distract you from the forensic audits. COVID is a HOAX, Delta is an airline, MASKS are for slaves and halloween. They stole the election from the people. Times up, time to pay the piper.
Oh Sam, I love you man.
Sometimes I think you actually believe yourself.
How dare you assume my gender. ReeEEeE
Everything I said is facts. You know…
LOL @ Russ…I believe you will find the gender in the first three letters of the fourth word.
I still won’t take the shot.
There are some new vaccines in production that look, so far, to be less horrific than the ones they’re pushing now.
Remember from trials you don’t get a broader picture. When Pfizer and Moderna went into trials. Almost no issues showed. When a lot more people in the millions take it. There will always be some kind of set back in some people. The new vaccines could look good on paper but when millions take it. Will show different. I got both Pfizer shots and had no issues. Just a little sore arm for 1 day.
Makes no difference. Despite the approval, bribes, fear campaigning and peer pressure, the virus posses an insignificant threat to me. Pass.
Why cause you’re healthy? You act like it still won’t kill you or make you have a lot of issues later. A lot of people that thought like you are now dead and a lot now have medical issues. I wish you the best.
@Me
Yeah, because I’m young and healthy. Apparently we have different definitions of a lot because I don’t consider less than 1% to be a lot. If we lived in serious country that actually wanted to improve people’s health, our medical experts would be advocating for people to lower their bmi through diet & exercise. But we don’t live in a serious country. Instead they push an experimental drug therapy for everyone whether they are a healthy 30 year old, or naturally immune, or an obese diabetic in the autumn of their years.They also continue to stoke tension between the mask/anti-mask, vax/anti-vax crowd knowing full well what it’s creating. I’ve done the cost-benefit analysis and know exactly what time it is. Save your wishes for someone that wants them. I’m good.
You need to understand something. 1st, I said 2 different things. Not just death. You could also develop long term medical issues from the virus as it has been documented from 1000s and 1000s of people. 2nd, you don’t have natural immunity against a coronavirus. If you go get tested for antibodies. I promise you it will say you have none unless you’ve already been infected. You have to understand stand as well, before the hospitals were able to figure out what to do. We were over a 6% death rate at one point. If you want to take a chance that’s on you. And last. You say they are putting tension on anti people and the people who believe in the stuff. That’s wrong. People like you are the ones who are creating it. If you don’t want to get the shot that’s your problem. But trying to say lies about fear campaigning and dumb lies trying to prove a point is the issue. Not the media. You come on here and you post things and try to act like all this is dumb and all that. But what you don’t realize is you’re the one that is causing the drama.
@Me~Whoa…Wimpy would not like to take a bite out of the big ‘nothing burger’ you just served up! You say it’s Pine’s problem for not getting the vaccine, but you see, there is no problem–just your projection that there is one. Isn’t that a Saul D. Alinsky rule?
Thank you for your post, Pine Barrens!
Before you make yourself look even more dumb. Read what I wrote again. I never once said it was a unvaccinated person fault. I said it’s people like him spreading lies. There are people out there that have been vaxx and spread lies as well. You shouldn’t twist words as you just proved my point…
“I encourage all Californians to trust the science” Whenever gavin says that stupid phrase, I always question if he even has a clue about which “science” he wants us to follow or trust, or if he is just parroting that favorite phrase of 2020.
Maybe he means the science that kids have a China virus survival rate of 99.99995% or that the overall population has a 99.5% survival rate, and that the vast, overwhelming majority of deaths occurred in people with 2+ comorbidities, not exactly the SCIENCE that cries out for injecting an experimental gene therapy.
Or maybe it’s the SCIENCE that just about any mask except for a PROPERLY FITTED N-95 is practically worthless and is nothing more than fear-porn theater.
if the masks work
then why a shot
if the shot works then why the mask
I’ve already had the China virus, I have antibodies, no reason for me to inject myself with this “vaccine”.
It’s interesting how quickly people shifted from claiming they wouldn’t get the unapproved “experimental” vaccine to asserting they won’t get the approved one either.
I mean we knew you were lying but it’s comforting to have proof.
How about ‘ERas, Chuq, Me, Pyrrhus, popcorn, Hanne’ all just butt out of people’s PERSONAL health situations! Until you start demanding to know who has: HIV, syphilis, herpes, epstein barr, lupus, lyme, CFS etc etc, you have NO right to infringe on peoples beliefs by requiring them to take a risky injection.
Do I need to just claim I’m Amish? Butt out and MYOB!!!
And remember: It was Your party who gave us ~ My body, My choice.
Don’t listen to Newsom. Remember that black voices matter, black lives matter, and that’s why you should vote Yes on the recall, and vote for Larry Elder! No more rich misguided white men! Vote Larry Elder!
See what I mean?
You really want Larry Elder???? lmao that is soooo funny. I’m so thankful you are not in a leader spot.
I love how everyone is saying that its FDA approved but they are outright lying to you. Read the FDAs documents. It is a permanent extension to the EUA. don’t be fooled by the media. Read it for yourself.
https://www.fda.gov/media/150386/download
No, no it is not, you are not correct and are n spreading misinformation. this is an extension of the EUA for those 12-15, every one 16 and over are under the BLA. This is the Approval letter, that can be found at https://www.fda.gov/media/151710/download. This is is the real BLA authorization….it is FULLY approved……
oh poor souls
read the documents
read the documents the scientists put out
read the documents that tell you we are right
read the documents that tell you your wrong
read the documents that tell you your children they can not succeed
read the documents that say the virus never came from china
read the documents that say what ever they want
because everything on a document is the truth right
we have seen the document truths that dont add up
we have seen documents saying we can not make our own decisions
we have seen documents that say jews are the end of the world
are these true or written by someone with a agenda or cover up
please we saw the flip flop cdc and WHO and the democrat political armada
we have seen the emergency passing of a Alzheimer’s drug right after the hoax election
the scientists were muted to talk about this and shuttered away
after voicing their wtf just happened voices of this experimental drug to slow effects of alz
and who do we know that this was and is being used for
there are not trials no hospitals reporting patients results
nope for one person to hold the narrative
weekend at binbidens
all documented
so you will believe it
ty for your obedience
believe everything the dem politicians tell you
they have the documents that say you should
lol the fauci said that china has documents showing they have no idea how covid got out or that they never heard of it or seen it or know anything at all
After four years of watching established politicians and institutionional government slander President Trump, trust is gone. The fraudulent Biden regime is proof. The vaxx is not a vaccination. Children do not need the mRNA mutating jab. It destroys the natural immune system. The vaxx is an experiment. The super spreaders are those jabbed with the Covid multiplying flu. My body My choice.
The virus is looking for you.
Prove it. Oh wait you can’t because like the post you did. Nothing but fake info you saying. You really need to stay off Twitter and Fox news
Apparently, the anti-vax crowd is terribly challenged by Basic Reading Comprehension at the 4th grade level. The PFIZER vaccine is now FULLY APPROVED by the FDA:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
*For the those 16 and over
The main error I’ve seen them make here is not lliteracy, but “confirmation bias”. Instead of making an effort to test their own beliefs by trying to falsify them, they are just running with the thing that apparently validates them.
The issue of confirmation bias would not exist if there were not room for disagreement. When the polio vaccine came out, parents were wildly enthusiastic about it. Trust in government has been falling, and in the last four years the by-any-means-necessary types did huge damage to any remaining trust. The same politicians most insistent you get vaccinated are the same ones who shamelessly lied to us non-stop for four years. The drug companies are famous for price gouging. Dr. Fauci said we do not need masks, then reversed and said we did and that he was lying so the first responders could get them first. I would be distressed to see Americans at this point believing anything without skepticism. Do you believe Joe’s kid with no professional art training is now magically an artist like Van Gogh and his stuff is worth $500,000 each?
Dear Anti-Vaxers and “my body, my choice” folks, for the love of GAWD, please get vaccinated! This virus is not a hoax and it’s mutating like mad and WILL KILL many more thousands of people if we don’t get it under control! GET VACCINATED or be ostracized!! (and you’d deserve it!)
I’m too scared I keep thinking about how Kamala and Biden said they wouldn’t trust it bc of Trump/ Operation WarpSpeed
Mimi you seem like a real fun loving gal … very tolerant
Even after all the ills of the virus, it’s important to note that the worst of what’s been wrought is from the government’s response.
Biden And Kalama NEVER said they didn’t trust it. They said they didn’t trust how fast it was going and that he needed to see all the info before making a choice. People who keep saying that Biden and Kamala said this and that need to stop twisting the words.
https://twitter.com/i/status/1416094954603044864
“But if Donald Trump says we should take it, I’m not taking it”
@Me Admittedly, I haven’t cared enough about what those two nimrods say to pay attention to them, but it looks like their statements have run the gamut.
@Bob
A little hard to not noticed what they say since they are all over the news lol. I will say Biden has done some very questionable things that’s for sure.
Amazing…they didn’t even submit the research data, documented side effects or findings yet. Those data and findings have not been finalized and are not even in print yet..but “since they said its approved, I will take it now”..said no thinking person ever. How many people even know how to read the VAERS reports?
Yes data was submitted, side effects have been documents and the findings are that the vaccine is efficacious and effective against Covid-19………the findings are in print have been analyzed and found to be valid! sounds like you have no clue how to read VAERS as “When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established” from the VAERS website https://vaers.hhs.gov/data/dataguide.html.
Not true.
Sadly, you continue to promote a FALSE narrative.
https://www.nejm.org/doi/full /10.1056/NEJMoa2034577
Good luck, the conclusive findings have NOT yet been documented. Those findings have not yet come due. Read the reports. This was sped forward without the final documentations..not the on going 9 month findings. But from the sounds of it, the trust in the FDA and these companies is so great, I am sure many of you will step right up to test the new vaccine being put out by Maderna….The New AIDS vaccine trials are coming as we speak.
I am just wondering if these jobs have contingency plans if half their employees say no……are jobs prepared to handle no staff? how about the people not vested in retirements? they will say fine fire me..or walk..or how about those who just say fine..fire all of us who refuse…how do you like those “help wanted signs” Now?
Good, they can go live in the shadows of society, or move to an unvaccinated third world county, while the rest of us move on. Ever had measles or polio? Me neither, thanks to vaccines.
this is the consequence of an “at will” employment scheme conservatives have been pushing….oh look, the consequences of my own actions!
@9
wishing others to go be homeless, i.e. live in the shadows, is unAmerican and just a horrible thing to say, shame on you.
“Trust and Science”. Somehow those words are cheapened when regurgitated by Gavin Newsom.
Since when have we trusted the FDA for anything? It’s another bought out corrupt government agency. What a joke!
In the meantime the French continue to spend their weekends protesting overreach by their public officials and Australian truckers are going on strike at the end of the month. Australia has turned into the epitome of a new world order Orwellian nightmare.
You are correct to ask, when have you trusted the FDA? Do you take OTC drugs? bet you do, so then you trust the manufacturer and the FDA as to there safety and efficacy, on any prescribed drugs? oops, Doctor, Manufacturer and FDA……
Just wondering if those who trust the FDA and for that matter the company that is creating the new AIDS vaccine by Moderna will be willing to get into their trials?
It’s so funny the Antivaxxers and Conspiracy Theorist always have to make an excuse for something. As @Really said. Have you never taken any medicine before? Weather it’s OTC or prescribe. I am 100% confident you have. So then that means you have trusted the FDA before. Oh, and I am sure you have gotten vaccinated from other things weather it’s a flu shot or something when you were a child.
It’s so funny reading all the lame excuses. Oh I now don’t trust the FDA, oh it hasn’t been fully approved, oh it’s a government hoax, oh it’s changing your dna, oh you can’t have babies because it causes fertility problems. The crazy stuff you read on here…
I mainly use alternative medicine which involves using vitamins and herbal supplements. Companies in that field have said they would like to see some regulation if for nothing else being sure their sources are providing what they say they are.
As for prescription drugs, an oral surgeon gave me Vioxx back in 2003. I didn’t like the reaction I got from it at all. And of course Vioxx was later taken off the market.
The FDA is swayed too much by big pharma who we frequently hear wants vitamins supplements prescription only. Obviously so these crooks can harvest the profits from them.
We also seem to be living in Huxley’s “Brave New World” these days.
I agree with Capt’n Bebops. The first line of defense is promoting good health. The intestinal flora is our body’s immune system. Drugs and additives destroy the balance. Take a multi spectrum Prolific that bypasses the stomach acids and deposits the good stuff where it can work, in the intestines.
Second, if you have taken antibiotics recently, dose yourself occasionally with a probiotic. Also eating fermented foods. A friend had problems with radical acne, for years. When he stopped the doughnuts and other crap plus took probiotics, it cleared up.
As for snarling at those of us for participating in our health, time will tell. Most have been exposed to Covid19 by now. Those who elected out of the experimental jab have already developed herd immunity. Some of those that submitted to the experiment have been permanently injured and some have died. To ignore ALL of the information, is unscientific at the very LEAST.
The mRNA jab is an experiment. Some of the observations point to the jab as interrupting the normal immune response. Frontline doctors, nurses, researchers, families. A many and diverse group. There is also evidence that the delta variant is manufactured in the body of a jabbed (not a vaccination by definition), human subject.
I’m holding out .. still waiting for the independent rigorous studies that Newsom and Cuomo both said they were going to accomplish before anyone started taking the vax
Recall Newsom
Todays question of the day…ask your younger friends…you want a shock? Yea, well thats where we are as a society..those old enough to remember history will understand this question in relation to Covid. Go ahead ask and get a reality check
.How many young people would be willing to get a tattoo (if required) to keep their job?
Sadly, you continue to push a terribly FALSE narrative that is not based in any factual evidence.
The State of California is the largest employer in the State. No one is getting fired for not getting the Covid vaccine. The State is giving employees a CHOICE between getting the vaccine OR being tested every week.
what about the other employers? “false narrative” you are just a shrill for the left
#RecallGavinNewsom
Not for me. the vaccine was rushed, no long term affects known. (and bill gates was involved. heck he cannot even keep viruses out of his OS)
Times to develop vaccine for human use from virus discovery:
Covid – 6 mos
Yellow fever – 35 years
Polio – 45 years
Measles – 46 years
Influenza – 12 years
Hepatitis B – 17 years
Hepatitis A – 22 years
HPV – 33 years
Rotavirus – 25 years
HIV – none >38 years
Dengue Virus – 59 years
@ Amigo…. technology has advanced quite a bit since the first vaccines were developed. Shouldn’t we be able to produce vaccines faster now? Or is there more money to be made treating diseased patients rather than vaccinating them?
First year vaccine was available:
Yellow Fever 1951
Polio 1950
Measles 1963
Influenza 1945
Hepatitis B 1981
Hepatitis A 1991
Rotavirus 1998
Dengue Virus 2010
Allegedly, it’s only because they “cut through the red tape”. It’ll be interesting to see the FDA’s timetable for approving the next major vaccine.
Will they say that the red tape is important and has legitimate value or will they continue to backtrack on their decades long track record and jump straight into, “we’re saving lives, d***it!”, And claim that the red tape of old was a needless thing.
1st you left out. Mumps vaccine was created in 4 years so…
I don’t think you understand how vaccines work. 1st, It took a very long time for those vaccines to be created because of the type of technology they had back then. Completely different then what we have now. mRNA has been around for over 10 years. The other reason why they took so long. They had to use actual samples of those viruses to create a vaccine. So a lot of mistakes were made when creating vaccines. mRNA does not. And the other reason. We have had other Coronaviruses before so they were able to learn off those genetics which they were able to zero in on the actual cause and develop the vaccine. Vaccine was not rushed at all. Saying you don’t know what the long term effects. That also tells me you don’t know much about vaccines. If any side effects happen. They show up with-in days of the shot. Not months or years.
@me
So do you get paid per post or per lie? Either way you are crushing it. You do realize your words are empty and meaningless right? We are winning the narrative.
Just remember some of us still know how to do math. Your masters should have waited another 10 years.
Sorry but unlike you. I have evidence to back it up unlike your fairy tails. You should really find someone who is clueless and don’t know anything “Kinda like you” that will follow the lies as your spread.
https://www.medicalnewstoday.com/articles/how-did-we-develop-a-covid-19-vaccine-so-quickly#Other-coronaviruses
@amigo – they crank out new flu vaccines every six months. The COVID-19 time line was not unusual.
Also, all medications contain a mix of ingredients with the “active ingredient” usually being a very small portion of the medication. That’s also the case with the COVID-19 vaccines. Adverse reactions to a medication, including the COVID-19 vaccine, are nearly always a reaction to one of the ingredients other than the main active ingredient. Google up “excipient” if you are interested in that topic.
The white mice are quitting.
This has been an interesting read. I think I fully understand how we can still have flat earthers.
I also see why people are afraid of technological advancement, I mean we still have people that don’t believe in germs and preach evil spirits cause disease.
For Real I do get the “don’t trust the Government or Scientist”. I mean it’s not like they haven’t lied to us before for their own gain. However, having a healthy dose of skepticism does not mean cutting off your nose to spite your face. Unfortunately, Scientist, like economists, are updating their positions as new data comes in. This makes it hard for us less edumacated on germ theory and how this level of biology works. I mean look how long it took to get people to believe that the earth revolved around the sun. (talk about a mix of religion, government, and science) Oh, wait…enter the flat earther.
In all reality, you truly have no clue what the shape of our realm is. Without “trusting the science” you have zero first hand information. Go ahead and admit it. You don’t actually know what you’re saying is true. It’s just what you’ve been told all your life so you think it must be true. But you really don’t know do you?
Why is it whenever I read these posts on getting jabbed and Covid in the back of my mind “Another Brick in the Wall” is playing over and over. What happened to people?
That’s because the state pays propagandists to post. gavin newsom told us that he was going to do it when he got the COVID money. He created an army of social media posters to flood the zone with state propaganda. We have several of these paid shills here whenever something about the vaccine, masks or the virus comes up. All the posts come with the same sucking sound. Easy to spot when you know
That’s why I’m here regularly making their jobs difficult. Dragging them out of their holes causing them to expose themselves over and over.
It is not a vaccine
My understanding is the Pfizer approved vaccine “COMIRNATY” is not the vaccine you will receive if you go out and get vaccinated tomorrow. It is a conditional approval, and if you get vaccinated tomorrow you will still receive the EUA vaccine. Also, COMIRNATY is not FDA approved for children under 16. I can’t help but feel misled by the media once again, and it’s no wonder people lack trust in this vaccine.
Did you think the games were gonna stop? The government is having way to much fun controlling people now. I told you people to refuse the mask and shutdown at the very beginning. Now we all have to suffer because some of you were to weak minded to know when you’re being jerked around.
https://rumble.com/vlmd4g-pfizer-seeking-full-indemnification.html