give pFizer a break. /s
first, the liars who sterilized America KNOWINGLY
and induced diseases in the rest which appear over years,
THIS time ran their USELESS test for a whole 7 days.
Posted on 08/23/2021 6:51:03 PM PDT by SeekAndFind
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…
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.
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.
It is necessary to know what they kicked upstairs to The Big Guy before reaching a any sort of conclusion on the scientific merits of the decision.
And, the gov’t bureaucrats at the FDA could not possibly care less about any criticism. Their attitude is YOU will Comply with our mandates or else. How much longer will Americans tolerate this bureaucratic tyranny?
“Critics blast”
As if critics ever endorse or agree
“Science” is what we say it is.
What was needed was action by the Vaccines and Related Biological Products Advisory Committee before approval!!!!
But the FDA recently approved Biogen’s near-worthless Alzheimer’s treatment DESPITE its rejection by its Advisory Committee!!!! The biden-era FDA needs to restore its integrity and credibility before the public will believe its recommendations!!!!
Millions of people have already received the Pfizer shot, so we have a pretty good idea of the short-term dangers, but we still don’t know what the long-term safety is - and that’s of vital importance - literally. So how can it be fully approved after such a short time?
numerous meetings in 2020...no mention of 2021 when adverse reactions became public
7 days? so weekly boosters then?
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