News: FDA approves Pfizer “vaccine” – But why?

What is really going on? Why do I ask this? Read the documents, listen to the audio referenced of the Doctors. Use your own brain, stop throwing away your personal responsibility to use God-given intellect beneath the boots and war tanks of the governments’ and medias’ suppression of information.

https://www.fda.gov/media/150386/download . 

Why the name change?? No alternative treatments available??!!  How are these FDA officials being allowed to get away with this??  Congressional investigation necessary immediately, require accountability, get those legal protections these vaccine producers hide behind eliminated immediately as well as requiring them to list ALL ALL ALL ALL ingredients in their products!  Just imagine how foreign genetic changes in the recipients of every and all sorts could result (just as the Pfizer mRNA “vaccines” change the recipients own genome!!) –Dr. Zelenko was probably correct!  Who benefits financially from these Pfizer patents (guess who!!!)??? —  DNI]

Reference from Dr Zelenko: http://thephaser.com/2021/08/dr-zev-zelenko-exposes-global-genocidal-event

Me: My parents know someone who “reads everything and made up her own mind” about initially getting the shot. When she learned about the boosters, because of the Delta variant, she went to get one. She didn’t wait 8 months, and got the booster only after 4. She is now so sick she thinks she is near death because of it. This timeline of outbreaks and variants was all orchestrated this way. Winter, not Summer, is the time when viral illnesses are naturally at their peak, because Vitamin D intake from the sun is at its lowest. The lab leak and the spike protein mRNA “vaccine” being pushed, while hydroxychloriquine and ivermectin and zinc and other oral and more successful treatments are all being denied and suppressed… These “vaccines” are the primary cause of the variant of a coronavirus adapting itself, in this Summer season. They are sociopathic serial killers behind all this, trying to engineer humanity to destruction. The US govt is in on it + UN. The Pope+most Bps are at best a duped slave to – and at worst apathetic coconspirator with – the CCP.

I feel for those who get sick, and for those concerned for them. Truly. I have a cousin who got Covid (I am assuming the Delta, my father thinks it was the original), and truly almost died. His mother is my Aunt+Godmother. He, his wife, and his two kids got it, but he definitely got it the worst. Dad and I would audio record us praying the Divine Mercy Chaplet and the Litany of the Precious Blood together and send them to him, so he would be able to listen at his situational desire/convenience (his O2 levels were extremely low, he couldn’t speak to pray with us). He did recover.

My younger sister’s college classmate (only a few years graduated) died from complications of the vaccine, and was one of the earliest reported on VAERS.

I have friends who lost good coworkers and friends. They had died due to complications caused by the vaccines.

I have friends who work in the medical field, from heart surgeon to vascular specialist to RN. They’ve each heard from other medical practitioners who are afraid of reporting and openly discussing this matter for fear of being labeled “crazy”. The surgeons know the “mask” mandates and policies are all politics, not science, and that face masks (all forms) do absolutely nothing against the transmission of any virus.

That said, here is an article below about our national headline.

FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate

Children’s Health Defense

August 23, 2021

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.

by Megan Redshaw

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.”

Published by endallwar8894

Just a little Catholic living a hidden multidimensional life.

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