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You are here: Home » News » Jesuit Controlled Organizations » Pfizer » FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate

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

August 23, 2021 4:30 PM By Children's Health Defense 1 Comment

Originally published by Childrenshealthdefense.org.


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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.”


This post was originally published by Childrenshealthdefense.org.

Author: Children’s Health Defense

The mission of Children’s Health Defense is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and to establish safeguards so this never happens again. CHD was founded by Robert F. Kennedy, Jr. and he serves as Chairman. For over three decades, he has been one of the world’s leading advocates of humanitarian and environmental causes. He is also founder and president of Waterkeeper Alliance, the umbrella group for 300 local waterkeeper organizations, in 34 countries, that track down and sue polluters. His father, Robert F. Kennedy, served as United States Attorney General (1961-1964) and United States Senator from New York (1965-1968).

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annabel
annabel
8 months ago

https://warroom.org/2021/08/24/dr-malone-calls-out-fda-for-bureaucratic-shell-game-on-vaccine-approval/

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  • Phil - Sydney on Powerful Prophetic Word – Luke 13 Attitude of Our Hearts – Strive To Enter In!Asking ALL Christians on z3news. Please pray for Ralph Babet for a UAP senate position for Victoria. Australia. He has a real chance . Thanks Everyone. May God bless him and give him success... Praise…
  • saira khan on “I will complete My promise to My Chosen…”I agree. Rational thinking
  • Marques on “I will complete My promise to My Chosen…”There are numerous prophetic voices talking about this. This is not the only year for wealth transfer, but I believe we will see a lot of the wealth transfer take place after DJT is restored this year…
  • Lewis Louis Esq. on “I will complete My promise to My Chosen…”Bo Polny did: https://qrco.de/bd1VRq
  • Glenn Clark on “I will complete My promise to My Chosen…”Thank you Maria for taking the time to share your posts. God has given me confirmation that you indeed hear from Him and so I'm thankful He is using you as his precious vessel to share His thoughts, w…
  • Larry in Alaska. on In my dream, I saw what seemed to me to be a tsunami wave.I agree, thank you Marcio.
  • Phil on “I will complete My promise to My Chosen…”Who predicted 2022 was the year of the great wealth transfer? I didnt hear 2022 being named as the year before
  • Phil on “I will complete My promise to My Chosen…”Stock market is likely to take a big hit after Germany industry stops and their power plants cant get the natural gas replacements without using Russia. End of summer would be my guess. A BTC crash to…
  • Fionnola Morris on Prophetic dream shows Trump returning to U.S. presidencyThe only leader I believe in is the Lord Himself. Certainly, while Pres Trump did facilitate the development of the mRNA injections, he also tried to reform, restricted abortion, funded black universi…
  • Fionnola Morris on I heard the words “Small World War”.No human being and none of the nations of the world are ´’righteous’ in or of themselves, only through the blood of Jesus: moreover, the only difference between the sheep and the goat nations is that…
  • Edg on “I will complete My promise to My Chosen…”I think the Big Crash for the Stock Market is Soon this year just before J P B passes away then God brings Trump back this year 2022 and btc Crash to Zero is Before the Stock Market Crashes and thats…
  • Edg on “I will complete My promise to My Chosen…”Amen 🙏🏼🙏🏼🙏🏼🇺🇸 Shalom 🇺🇸
  • Edg on “Barrenness is being broken off of the life of many who have not been able to bare fruit or to produce seed!”Amen 🙏🏼🙏🏼🙏🏼
  • jimparsey on I heard the words “Small World War”.Yes, even I commented something about z3 few days ago on Telegram and he blocked me. Impatience, Anger are qualities of Devil. May lord free him from the clutches of evil and show him the right path.
  • Undisclosed on “I will complete My promise to My Chosen…”nice find
  • William on I heard the words “Small World War”.We are all on the potter’s wheel brother. We all have rough edges that need smoothing.
  • Anthony T. on God is turning America now in its pathwayThank you for sharing this, Susan. If we take 40 weeks as average for a pregnancy and add 3 weeks to the date of your dream which was on May 18, we come to June 8. As no one knows the date or the hour…
  • Joe on “I will complete My promise to My Chosen…”Genetically Modified Strain Of Monkeypox Kills 250 Million People In War Game Simulation Prompting New Pandemic Warning - GreatGameIndia Is this the event that causes crypto crash in July. The dates g…
  • Liliane on “I will complete My promise to My Chosen…”Thats so beautiful William! I believe in faith this will come to pass :) Some things only God can come up with.
  • mem on Pure Evil Spreading Through America and Consuming ItAh I see Brian used Benners mechanical translation. NICE! Love that for study. I recommend his individual books And the dream...amazing. we too in late 2015 had a warning dream about quaruntine and fo…
  • mem on I heard the words “Small World War”.Which prophecies reference Finland that you are talking about?
  • DavidESP on I heard the words “Small World War”.I have followed Christopher Harris for years now. I do not feel that this man moves in the love of God that edifies the body of Christ. He comes across as a harsh man who tolerates no dissent to his "…
  • William on “I will complete My promise to My Chosen…”The Lord gave me a dream a while ago of a small lovely little village called Clifton Reynes, where I think the Lord intends me to live at some point in the future. There is one pub in that village and…

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