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Editor’s Commentary: Why? That’s the question that nobody seems to be asking. Perhaps the answer is just that obvious, but it needs to be asked anyway. Why did the FDA rush to “approve” a drug that was already given Emergency Use Authorization? The “approval” does literally nothing from a practical perspective. No additional American is eligible to get the shots who wasn’t eligible before the “approval.”
The answer is obvious, but it’s deeper than what we see on the surface. The Biden regime wanted to take down one of the roadblocks keeping businesses and agencies from mandating the vaccines for employees. This was a very political optics move and reminds us that the FDA is not a medical or scientific organization. They are a full-blown political entity.
As for why Pfizer was selected as the opening choice for approval, there are theories ranging from greed to much, much worse. I’ll dismiss the greed factor, though it’s probably part of it. Others can dive into bank accounts and follow the money. I want to propose the evil theory. Considering the Pfizer “vaccines” have demonstrated the least efficacy and the highest rate of adverse reactions of any of the three available injections, perhaps they were selected because they “work” so well. Are the Pfizer vaccines, which account for more than half of the adverse reactions and nearly three-fourths of the deaths recorded in VAERS, doing the best job the powers-that-be intended from the start?
Megan Redshaw reports the news thoroughly, as always. Read through her article and ask yourself why all of this is happening. What does it all mean? Is there any way to stop it? Is it time to head for the hills? Here’s Megan…
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.
“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.
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“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.”
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
The Dangers of Speaking the Truth Diminish If We Work Together
It’s becoming harder and harder for patriots to ignore the deep suppression of truth that’s happening in America today.
In all of my years in journalism, I have never received as many threats or been attacked by big companies like Google and Facebook as I have in 2021. I’d say that ever since we started covering widespread voter fraud, government-endorsed Pandemic Panic Theater, vaccine cover-ups, Critical Race Theory, and the various Neo-Marxist and Satanic agendas at play, I’ve been targeted more in months than the entirety of my life prior.
Speaking the truth is getting harder with so much censorship and suppression rampant. Prior to 2020, I was not a “conspiracy theorist” or an “anti-vaxxer,” but if there’s one thing the onslaught of exposed lies have taught us in the last 18 months, it’s that we cannot take what we’re told by the “arbiters of truth” at face value. There’s an agenda behind every message, a narrative driving every story, and a series of gigantic cover-ups designed to keep the masses in the dark.
This is why we’re building a network of news outlets that are willing to go against the narrative and expose the truth. We need help. We’re establishing strong partnerships with like-minded news outlets and courageous journalists. Even as Big Tech suppresses us, the honest messages they’re trying to quash are finding their way to the eyes and ears of patriots across the nation. With the help of new content partners like The Epoch Times and The Liberty Daily, we’re starting to see a real impact.
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I’ve said much of this before. From time to time I reframe this request for assistance by taking the most relevant message of the day and adjusting the story accordingly. We’ve discussed this network in previous articles. Now, it’s time to talk about help. First and foremost, we need financial assistance detailed below. But we could also use more writers who are willing to volunteer their thoughts for the sake of spreading the message. Those who are interested should contact me directly.
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Thank you and God Bless,
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