Critics said it was concerning that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data.
The U.S. Food and Drug Administration (FDA) today granted full approval to the Pfizer/BioNTech COVID vaccine for people 16 years and older — without allowing public discussion or holding a formal advisory committee meeting to discuss data.
This is the first COVID vaccine approved by the FDA, and is expected to open the door to more vaccine mandates by employers and universities.
“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” U.S. Surgeon General Dr. Vivek Murthy on Sunday told CNN’s Brianna Keilar.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Dr. Janet Woodcock, acting FDA commissioner in a press release issued Monday.
“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 this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”
Woodcock said she believes FDA approval will instill additional confidence in people to get vaccinated.
According to The Washington Post, Pfizer’s vaccine approval was the fastest in the agency’s history, coming less than four months after Pfizer/BioNTech filed for licensing on May 7.
“It’s been remarkably fast,” said Holly Fernandez Lynch, a bioethics expert and lawyer at the University of Pennsylvania, who said careful handling of the approval was crucial to potentially persuading the “vaccine hesitant” to receive the licensed product.
The approval of Pfizer’s COVID vaccine was based on its clinical trial of 44,000 people — half of whom got the shots, the company said. The median six-month follow-up period for safety and efficacy began after participants received their second dose, Pfizer said.
“Based on the longer-term follow-up data we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a statement. “I am hopeful this approval will help increase confidence in our vaccine.”
The company plans to follow the 44,000 enrollees for a total of 24 months, from the start of the trial. In order to qualify for FDA Emergency Use Authorization (EUA) last December, Pfizer followed trial participants for a median of only two months after participants received their second dose.
Pfizer’s COVID vaccine received EUA on Dec. 11, 2020, for use in individuals 16 years and older. On May 10, the authorization was expanded to include 12- through 15-year-olds.
According to the FDA, EUAs can be used by the agency during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose or treat the disease, outweigh the known and potential risks of the product.
Pfizer’s vaccine will remain under EUA for 12- through 15-year-olds, and for a third dose in certain immunocompromised individuals.
However, full approval gives doctors flexibility in using vaccinations for “off-label use,” which is not permitted for EUA products. This would allow doctors to give patients booster shots before the FDA clears them.
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.
Critics accuse FDA of ‘unprecedented, naked power grab’
According to an article published Aug. 20 in the BMJ, transparency advocates have criticized the FDA decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval — an important mechanism used to scrutinize data.
Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”
But in a statement to The BMJ, the FDA said it did not believe a meeting was necessary ahead of the expected full FDA approval.
An FDA spokesperson said the agency held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to COVID vaccines in 2020, and did not believe a meeting was needed related to this biologics license application for Pfizer.
According to the BMJ, companies typically apply for full approval after a longer period has elapsed so that more data are available for review.
Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinizing the data.
“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,” said Witczak. Wticzak was one of 27 experts who launched a citizen’s petition demanding the FDA “slow down and get the science right” before approving COVID vaccines.
“The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing,” Wticzak said. “These meetings offer a platform where questions can be raised, problems tackled and data scrutinised in advance of an approval.”
Witczak said it’s concerning that full approval is based on only six months’ worth of data — despite clinical trials designed for two years — and there’s no control group after Pfizer offered the product to placebo participants before the trials were completed.
“They know they can’t win this argument on the science and that’s why they had to abolish the public process and independent oversight,” said Children’s Health Defense Chairman Robert F. Kennedy Jr. “They believe themselves so powerful now that they are stripping off all pretenses that this is about public health, and are baldly revealing the corruption.”
Kennedy told The Defender:
“This is a sinister scheme for mandating a badly flawed vaccine that has already made history with record deaths and injuries, that neither prevents disease nor transmission, and does not improve mortality. Pfizer’s most recent six-month data show that while the jab prevents some COVID deaths, it causes more heart attacks yielding a net loss of life.”
Diana Zuckerman, president of the National Center for Health Research, told The BMJ it’s obvious the FDA has no intention of hearing anyone else’s opinion, and says making decisions behind closed doors can feed vaccine hesitancy.
“It’s important to have a public discussion about what kind of data are there, and what the limitations are,” Zuckerman said. “As we think about risk versus benefit, we need to know.”Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and former FDA deputy commissioner during the Obama administration, said advisory committee meetings are more than just a way of receiving scientific input from outside experts.
“It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” Sharfstein told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence.”
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Zig Ziglar said it best: Integrity means there is nothing to fear because there is nothing to hide.
God bless RFK Jr.
FDA approval should be a red flag to everyone not to take the shot. I think, by now, world populations have come to suspect that it is dangerous to one’s health, has had many adverse side effects some quite deadly. If the Masters of the Universe try to force this on the world I think they will find a fairly strong and violent reaction against it. They have overreached and in so doing have exposed the true nature of their nefarious agenda. I think it is time for them to go to plan B. An Alien invasion from space?
RFK is right. They won’t hold the hearing because the science does not hold up. Not even plausibly.
A hearing would also question the authority of “experts” behind the science. Can’t have that, either.
Look for an upcoming Climate emergency. anti-vaxxers will be labeled as white supremacists. or terrorists since the jabbed get the virus from the nonjabbed. You cannot fight the logic of the Democrats/communists.
You are assuming they would honestly consider all information. They don’t give a rats hiney about logic, truth and honesty. Their goal is a simple one, gain control by any means. Especially by chaos and destabilization of social norms. They will stick with what they know, destruction.
“Look for an upcoming Climate emergency.”
If you will recall, once the ‘data’ showed a year ago already that the air was cleaner and such, the ‘climate scare’ folks used that against US … and now the 2 are forever linked in the minds of those controlling US … and in the ‘minds’ of their followers.
The vaxxed are secretly pissed. They now know how stupidly gullible they were (mostly politically orange man bad) and are angry and want everyone in their same sinking boat. They know they harmed themselves and are hellbent on you getting vaxxed and harmed like they did. They cannot stand knowing trump supporters, christians, gun owners, patriots outsmarted them and did not fall for the govt bs jab…..it really pisses them off. Keep pissing them off people! Do. Not. Comply. Angrily.
They do hate us. Work sent out a memo re unpoisoned and poisoned with respect to masks. It was broken into 2 categories.
To the unpoisoned: You must wear your mask EVERYWHERE, except for your socially distanced (puke at the term) desk.
To the coddled poisoned: Masks are required in common areas such as bathrooms, breakrooms, conference rooms, on your way to the printer. You may remove them at your desk.
Leah’s translation: Hey people, if you took the poison or not, you still have to wear your masks EVERYWHERE, except your desk.
When I mentioned the wordsmithing to a poisoned coworker, the hatred toward the unpoisoned was unbridled.
Still not taking it.
My objection isn’t about the effectiveness of any Covid drug.
I’m not convinced that it’s something I should worry about.
Are people dying in the streets? No.
Have large swaths of the medical employees died from contact with Covid patients? No.
Are people still going about their mundane, non-vital daily routines? Yes.
Come on man, we were promised bodies stacked like cordwood, mass graves in Central Park, and dark ages style body gatherers coming in the early morning with shouts of “bring out your dead”! I’m just as disappointed at this outcome as the fact that there are no flying cars a la the Jetsons.
2030.
Women seeking abortions and now congress agrees the health of a women is to include financial health. Therefore a baby is a burden to the mother. Well is forced vax and harm or losing your job for refusing the vax is also life threatening as is the financial burden of a baby justifying abortion can we abort the stupid fuckers forcing the jab or those that cause our job loss? People that lose their health insurance and their 401ks and income and go bankrupt will lash out. It is coming. They want a civil war. They will get one it seems eventually when enough people have nothin to lose.
They had to ram the clearance through. There is just way too much coming to light that is wrong, horribly wrong with these “vaccines” that aren’t vaccines. The spectre of ADE is raising real concerns. The deaths and severe illness numbers are too high to wait any longer. In 6 months the evidence will be so overwhelmingly bad, it wouldn’t be accepted
With approval, mandates will be crawling out of the woodwork and the pressure to get more stabbed will be immense.
9000 admitted deaths (easily 90,000) for this “vaccine” when another vax was pulled after just 50 deaths. Nothing to see here, move along.
It just confirms my fears about a dark psychotic agenda attached to this fiasco.
BASTARDS.
There is a peer reviewed article from a vaccine research journal, I have posted a link somewhere else that can provide if anybody is that interested, that basically showed that for a conventional vaccine the average time to clear clinical trials and development is approximately 5.7 years, but for an unconventional vaccine that timeline is somewhat longer, and they place this type of novel vaccine therapy in a third category. The authors posited got a vaccine at this time would take an excess of 12 years to develop in three trails, with only a 2% chance of success. And yet we see not one but two vaccines reliant on mRNA technology in less than a year. And now one is approved. Nope, still not gonna take it. It’s going to cost me a lot, but can’t spend money when you’re regretting previous decisions regarding your health. Actually, you can spend a lot of money and you won’t have much left for anything else.
I am interested in that article.
https://openvaers.com/
Thanks for that link.
I posted the front page of openvaers on FB with the question “Am I reading this correctly? 31 years of reporting adverse events from all vaccines and over one third (almost HALF) of all those reports are attributed to COVID-19 vaccines. And more than half the deaths reported. Wow.”
https://openvaers.com/
I was informed unequivocally that I was reading it wrong because vaers is a voluntary reporting system where the reports are not investigated therefore it’s obvious the anti-vaxers are spamming the system.
I was also informed by another independent researcher that each incident is probably reported 10-25 times each due to the fact that everyone along the chain of command *has* to report it.
http://chng.it/7DBNvSNcwx
I know of one death that is not reported on it.
And yet those people are surely the first to cry “conspiracy theorist!” at anyone who presents real, credible infomation that contradicts the narrative that they get from their televisions.
Of course the socialist parasites approved this poison they haven’t got the death and permanently disabled toll up high enough yet to cover the number of replacements they are allowing to flood across our border . The mad rush is on because the bodybags of those duped and complacent useful idiots are going to start piling up of those that ran out and got the jab believing the BIG CLUB BULL SHIT !
Come on man ! LOL When has BIG government BIG pharma BIG tech & BIG MSM ever pushed the same narrative over & over where it ever was the truly right thing to do and good for you all while silencing any dissent and mocking any who question the safety or effectiveness of what they are pushing !
WEF and the BIG CLUB CIRCLE JERK of Wall Street to K-Street to Capitol Street want you dead or totally dependent !
For those with the Cytokines Storm starting to rage in your body may your pain be relieved as you die . Reality Sucks
The good news is all my wifes friends i dislike are dumbass democrats all jabbed so they wont live long and i wont have to put up with them much longer. Thank you mrna vax. Thanks
Six months of data means that by definition there is NO complete information about the impact of fertility and the forming embryo/foetus. The FDA is a fraud, as is the CDC.
That’s part of the depopulation plan.
“FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate
Critics said it was concerning that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data.”
Because “TheScience!(TM)
I wish we had science like that when I was in graduate school, I could’ve possibly had my PhD completed by the time my advisor passed away 3 1/2 years into my program, instead of walking away after 4 1/2 years with nothing.
Like Rossa below I read the FDA letter and came to the same conclusion,so did that guy Malone? who invented the damn thing so who the heck is right.Just shows you how devious these authorities are
inasmuch as it appears to have fooled a lot of people .
Page 2, paragraph 2 of FDA’s own doc appears to indicate they only extended the EUA and didn’t give full approval.
https://www.fda.gov/media/150386/download
Karl Denninger says that if they did give full approval they broke the law without a full hearing and safety study. Also if the full approval is true, then the Moderna and J&J vaccines are now illegal to administer, yet Moderna’s share price went up yesterday when it should have collapsed.
https://market-ticker.org/akcs-www?post=243355
The other thing is if the Pfizer vax is now approved as safe, then surely Pfizer will now accept legal liability for their ‘safe’ product. Thought not.
Correct, FDA only authorized the extension of the “Emergency Use Authorization” (EUA) of the Pfizer vax to target (include) the 16-18 year old group. It is not a full authorization as the lying media and politicians are saying!
If it was actually fully approved, the other vaxes (Moderna, J&J, etc) would no longer be able to be administered since if there is an approved poison, they couldn’t use an EUA excuse anymore. Since it is still only available under EUA then the FDA knows it is not safe.
This is just an attempted end run to appease the emperor. It helps the additional nudging to get employers and other authorities on board without having to risk doing the actual gooberment mandate.
None of Pharma has liability for injuries from vaccines in the sense that another product would. You must take it up with a special “Vaccine Court” which operates by rules different from an ordinary civil court, and which awards damagesonly rarely. Otherwise there would be almost NO vaccines at all, as the liability costs would make production unprofitable. That’s for ALL vaccines, not just Covid.
No,they are not accepting liability which is why I think you have read the document rightly as opposed to a massive amount of journos and site owners.Not only is the communique vague ,it also manages to leave out so much of the health complications and detail that it is not really worth the paper it was written on.
“Witczak said it’s concerning that full approval is based on only six months’ worth of data…”
Pfizer couldn’t do that. You see, the people that were in the “control group” (the ones that got the placebo) were told very early on in the trial that they received the placebo and that if they wanted to get the real jab, they were free to do so. They completely destroyed the control group thereby any data they could gather in any time period be it six months or two years.
The sample size was only 44k, half of which received the poison.
Surely representative of the entire US population of millions. /sarc
Still not gonna take it. They can sit and spin.
I can’t believe that so many think the refusals have been based simply on its status with the FDA, and not the complete lack of liability, the hundreds of thousands of adverse events, or the tens of thousands of deaths…….or the fact that we all know this is about killing us all, not saving us all.
I am sure you are right in that they want a lot of us six feet under and I am sure that Gates ,as a well known eugenicist put up some of the dough required for Fauci to continue his gain of function and SRI Venglishi’s wages as well to offset Obama’s refusal to fund it any more after the scare they had in California.I saw a picture of them in the lab at Wuhan in 2019 but it was taken down almost immediately and,a few days later HCQ went off sales at pharmacies.I think what it was and is about is pensions,they just will not have the money required to be paid out,not to talk about food shortages etc.
If the Government says it’s ok then people will line up in mass! Brought to you by the same people who say Biden won the election.
So the Pfizer jab has an efficacy of 40% and during their testing they ‘lost’ the control group. Dr Gina Loudon stated this on Bannon show and backed it with an article and report from pfizer. The testing is invalid by any scientific rigor as there is no control group to measure by, which is of course the plan all along.
So the FDA looks to be as trustworthy as the CDC.
So the question is then, imo. Now that there is a ‘vaccine’ with FDA approval, does that mean all other EUO’s will be suspended?? Is it not the law that when there are treatments available then EUO cannot be given, after all that is why HCQ, Ivermectin etc were all attacked and not allowed to be used as treatments, this we know.
These criminals need to be held to account. Maybe… the truckers can shut the country down like they are planning in Australia. They are going to block all the roads, nothing moves for as long as it takes. Warning people to stock up now. Same should be done here.
Very interesting clip from an RFK Jr. interview.
Nut cutting time is coming real soon. Real soon.
The FDA didn’t approve the “vaccine.” All it did was to sell its soul. To this point, “FDA APPROVED” meant something. Now it’s a rubber stamp… one that your tax dollars and mine pay for…
…Once you lose your integrity, there’s no getting it back…
FLASHBACK;
https://www.cnbc.com/2019/06/27/former-fda-commissioner-scott-gottlieb-joins-pfizers-board.html
Additionally Bill scumsuck’n gates is honored to be a major shareholder in pfizer too… weird huh, no conflicts or suspicions there at all /s
A complete collaborative scam. They’re all in bed together.
He’s also the main private funding source for the FDA and for the WHO … also a strong believer in population reduction – saying that a 10-15% reduction of global population is possible with vaccines.
1. They are going to keep calling it a vaccine until virtually the entire country believes it really IS a vaccine … even among the vaccine-hesitant. It is not a vaccine. It is gene-modification. How many people would have taken the shot if they simply called it by its true name?
2. They are going to keep saying it’s safe. They are going to keep saying it’s safe. They are going to keep saying it’s safe. They are going to keep saying it’s safe. Until almost all people believe it.
3. We have truly officially entered the Dark Ages of Science. Fuck science. Science is what we say it is. Fuck you if you disagree. The word “science” means absolutely nothing regarding its original meaning. It is now a club used to bash in your face.
4. From the Star Ledger —> “Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000 page application and rigorous inspections. Never before has the FDA has so much evidence to judge a shot’s safety. Covid deaths related to the shot are exceedingly rare … just .oo1%
5. Number of pages dedicated to long-term effects / risks. Zero.
6. Announced today … Pfizer bought a cancer treatment developer for $2.26 Billion. They have NO products on the market! But, they are using “biologics” (whatever the fuck that is) to “prime a patients immune system” to search & destroy cancer cells. Sounds like fun.
7. NJ had 3 confirmed Covid deaths yesterday. Three. Yet the shitfuk governor says all 21 NJ counties are classified as high-risk … and masking, social distancing, blah blah blah will be back in full force shortly.
8. I’m pretty sure I recall reading or seeing vids here that Clot Shot Takers were going to start dropping dead around September. This seems to be total bullshit at this point. Why does our side have to partake in the bullshit lies strategy??
9. The unvaxxed will be fucked 6 ways to Sunday … at least in NJ, the worst state in America.
=========
In the good news departments…
10. The massive shithole mega-mall. once known as Xanadu, now called the “American Dream”, is about $3 BILLION in debt … and a lot of fat cats are looking at financial ruin. hahahah
NJ Cases
https://www.state.nj.us/health/cd/topics/covid2019_dashboard.shtml
NJ Mortality
https://www.state.nj.us/health/cd/topics/covid2019_dashboard.shtml
By the looks of it, this summer is pretty much the same as last summer for our friends in NJ.
The only way that Pfizer et al. got an EUA was – due to the requirements for an EUA – due to the government’s making HCQ and Ivermectin declared as not being a valid ‘cure’ or ‘treatment’ … otherwise, experience and positive results would have shown that there’s no need for the jab … and all of the bogus ‘cases’ would have never happened.
I despise Kennedys. I want to support RFK jr. My gut tells me he still votes Democrat and he is controlled opposition.
I see it as an opening for both sides of the country to band together against the Evil Fuqueres.
Dr. Malone was interesting on the War Room this AM. He says there are two products; the original vaxx still under the EUA, and the new “approved” Pfizer/BioNTech Comirnaty vaccine which is not available or even in production yet.
Bait and switch?
Cominarty is already used as the branding in some other countries, Australia as an example. It seems like semantics to me; EUA applies to “vaccine” produced before “approval”, and the same product branded Cominarty afterwards.
So the Pfizer Frankenjab is approved by the FDA…the gold standard of turd polishing….YYEAAAAAAAAH !
Perhaps before getting the approved Frankenjab the doctor must provide the patient with a list of fines etc that the company making the Frankenjab have paid and the amounts of money they give CONgress each year.
So they are legally liable now………….sue, sue, sue
No, they are not.
Just read an article about this that stated that the goobermint only EXTENDED the EUA !
If TPTB really believed in the efficacy and safety of their vaccines, they would not have removed an individual’s right to sue for damages.
Keep your pants on. There is no “full FDA approval of the Pfizer vaccine”. Just poor homework by media talking heads.
Vax Rage
I am going to predict some day someone that has lost a loved one due to the experimental serum or someone whose life has been horribly altered will lash out with tremendous rage. Think about it. A person is healthy. The serum does not stop the spread and does not protect you from getting the virus. There are other much cheaper over the counter treatments that are now shown to work better than any other meds out there. India proved this with vitamins, zinc, ivermectin and hydroxychloroquine. India is charging their head medical person with murder for pushing the vax. Shitshow has started. The nobel prize winning inventor of mrna has been doxxed, silenced and banned from all social media but he has clearly stated nobody will live past 10 years if they get this mrna vax. 89% will die sooner than 10 years. It all depends on how much remains in the body after 6 months. 30% effective you die in 7 years. 50% you die in 5. Whatever the effective rate is reduces your life expectancy by 10%. Masks do not work but they enforce mask mandates. Govt knows mandating a serum is unconstitutional but they for e private businesses to mandate the serum to keep your job. How is this not racketeering, collusion, and numerous other law breaking? The insanity is real and getting worse. This is exactly how nazi Germany was and the Jews literally thought eventually, surely, these fools would wake up and right the wrong and stop being stupid. This is gonna end in similar fashion. Patriots, unvaxed, republicans, normal people will be genocided. Bloodshed. This ends in bloodshed. History proves it does. Every. Single. Time. I fully believe there is coming some false flag similar to New Zealand and Australia where enough rage against guns will allow gun bans and confiscation. They must remove weapons and defenses from the people in order to genocide them. Unless the vax is their weapon and the corporations are the executioners. You job is not worth your life people. Its a new meaning for slavery when your job is forcing you to take an unknown serum that has unknown side effects but known side effects are devastating to human health. If you do not wake up scream loudly and make boisterous angry borderline violent or steadfast opposition they will continue to change laws and definitions to genocide you and kill your freedoms. They already changed the definition of vax to fit this serum. When you factually investigate you know they are at war with you and your continued blissful ignorance does not mean there is no war it just means you are surrendering silently. If you think you will avoid pain you are stupid. Let me repeat you are a fucking dumbfuck if you think they will magically stop about face and reverse their power grab. History shows the only way to remove dictators and tyrants is without their heads. This is going to get much worse before it gets better. I predict there is bloodshed coming if history is a guide. I also predict people that have been vax harmed will become lone wolves hell be t on revenge. Doctors, nurses, politicians, corp execs will be found face down in the future and the news will report these odd finding until it is knows they were assassinated by the vax raged. They will want their pound of flesh. Revenge. This too is coming. Nothing good will come from this greed and power grab. Nothing. Prepare yourself mentally and physically for things you never fathomed. The atrocities you will witness will shock you. These fools have open a literal can of hornets not worms. Tempus fugit momento mori.
That’s why TLPTB are already setting up the un-“vaxxed” as the target of the rage you posit — and these fools are dumb enough to be easily misdirected as such. They “trusted” the gubmint and media whores regarding the “vaccine”, so they’ll go after whoever they’re told to target. Not all, but a good many will.
Just read that the FDA did not approve the vaccine, simply renewed emergency authorization. See here https://proudamerican.site/breaking-no-the-vaccine-is-not-fda-approved-not-even-close/
Have you guys seen this??
That’s a lie. Here is s quote directly from the FDA approval letter (in footnote 8)
“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.“
The “certain differences” are not specified, but it is perfectly clear that the two jabs are legally distinct.