Posted on 08/23/2021 8:38:16 AM PDT by RandFan
On Sunday, U.S. Sen. Ron Johnson (R-Wis.) sent a letter to Dr. Francis Collins, Director of the National Institutes of Health (NIH), Dr. Rochelle P. Walensky, Director of Centers for Disease Control and Prevention (CDC), and Dr. Janet Woodcock, Acting Commissioner of the Food and Drug Administration (FDA) on the FDA’s decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its Covid-19 vaccine.
“I see no need to rush the FDA approval process for any of the three Covid-19 vaccines,” the senator wrote. “Expediting the process appears to only serve the political purpose of imposing and enforcing vaccine mandates. The observational phases of FDA approval take time, because there is no substitute for time in detecting and determining possible long-term harm. Additionally, we are already experiencing a severe health care worker shortage. Frontline doctors and nurses that are contacting me are expressing grave concerns about vaccine mandates which will only exacerbate the shortage.
“Over the last year and a half, the decisions of federal health agencies have dramatically affected the lives of all Americans. The impact of these decisions has been felt in Americans’ treatment options, employment, schools, housing and travel, and in countless other ways. The human toll of the social restrictions and economic devastation is incalculable. Unfortunately, your federal health agencies have not been transparent with the American people about how these life altering decisions have been made or what science and data they are based upon. I urge you to provide the information I have requested in my previous letters and to reconsider your decision not to assemble a VRBPAC public meeting prior to the granting of any final Covid-19 vaccine approval.”
The full text of the letter can be found here and below.
August 22, 2021
The Honorable Francis Collins, M.D., Ph.D.
Director National Institutes of Health
9000 Rockville Pike
Rockville, MD 20892
Rochelle P. Walensky, M.D., MPH
Director Centers for Disease Control and Prevention
395 E Street SW
Washington, DC 20024
Janet Woodcock, M.D.
Acting Commissioner
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Dear Drs. Collins, Walensky, and Woodcock:
According to an article published on August 20, 2021 in The BMJ, the Food and Drug Administration (FDA) has decided “not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine.”[1]
In a statement, the FDA reportedly told The BMJ that the agency did not believe a meeting was necessary because “t]he FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 2020 meeting to discuss, in general, the development, authorization, and licensure of covid-19 vaccines.”[2] An FDA spokesperson added, “[t]he Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020. If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.”[3]
As you are well aware, I first raised the issue of vaccine safety signals coming from FDA and Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) in a meeting with National Institutes of Health Director Collins on April 27, 2021. Since then, I have written four oversight letters on the subject of vaccine safety, effectiveness, and adverse events.[4] To date, I have received little to no substantive response. This lack of transparency is unacceptable.
As of August 20, 2021, VAERS is reporting 12,791 worldwide deaths associated with the three Covid-19 vaccines available under an FDA Emergency Use Authorization (EUA). Of those deaths, 4,632 occurred on Day 0, 1, or 2 following vaccination. As the CDC and the FDA are quick to point out, VAERS reports do not prove causation. But this number of deaths, particularly with 36.2% occurring within 2 days of vaccination, should raise serious concerns.
It should also be noted that the 12,791 deaths related to Covid-19 vaccines reported on VAERS over the period of 8 months, compares to 8,966 deaths related to all other vaccines reported on VAERS since the inception of VAERS – a period of 31 years. And this does not raise alarm bells within your agencies, or cause you to reconsider assembling an independent safety panel of outside experts?
In addition to deaths, VAERS is also reporting 16,044 permanent disabilities, 51,242 hospitalizations, and 571,831 total adverse events related to the Covid-19 vaccines. I am receiving a growing number of letters from doctors and nurses detailing the vaccine injuries they are witnessing and treating, together with the suppression and censoring of this information they are experiencing.
Your agencies’ dismissive attitude toward natural immunity has also been puzzling to say the least, and may increase the chances of vaccine injury in previously infected individuals. In its May 19, 2021 advisory, the FDA specifically discouraged Americans and their physicians from determining the status of their antibody immunity to SARS-CoV-2. It would seem to me that more medical information, not less, is the key to improving health outcomes related to any disease, including Covid-19.
Since the FDA’s last VRBPAC public meeting, in addition to the VAERS data, there have been a number of safety concerns raised by highly qualified medical professionals and researchers. A petition signed by 31 medical professionals and submitted to the FDA argues there is no need to short circuit the full approval process, including public safety forums, since the EUA is making the vaccines available to anyone 12 years or older choosing to be vaccinated.[5] Some researchers are concerned about the unblinding of Pfizer’s placebo group and how that will impact the reported trial results on safety and efficacy. Recent data coming out of the U.K. and Israel regarding vaccine efficacy raises a number of questions including: “Why isn’t the same data regarding U.S. breakthrough cases available to the American public?” All these issues should be discussed in a transparent and public forum.
I see no need to rush the FDA approval process for any of the three Covid-19 vaccines. Expediting the process appears to only serve the political purpose of imposing and enforcing vaccine mandates. The observational phases of FDA approval take time, because there is no substitute for time in detecting and determining possible long-term harm. Additionally, we are already experiencing a severe health care worker shortage. Frontline doctors and nurses that are contacting me are expressing grave concerns about vaccine mandates which will only exacerbate the shortage.
Over the last year and a half, the decisions of federal health agencies have dramatically affected the lives of all Americans. The impact of these decisions has been felt in Americans’ treatment options, employment, schools, housing and travel, and in countless other ways. The human toll of the social restrictions and economic devastation is incalculable. Unfortunately, your federal health agencies have not been transparent with the American people about how these life altering decisions have been made or what science and data they are based upon. I urge you to provide the information I have requested in my previous letters and to reconsider your decision not to assemble a VRBPAC public meeting prior to the granting of any final Covid-19 vaccine approval.
Sincerely,
###
Not a big deal unless one of them is your loved one. It is a personal decision. If you want it, go get it. If not, don’t.
1 death out of a trillion? Zaggerate much?
I just heard some talking head today, saying that with FDA approval the “untested” excuse is now off the table. It’s been widely tested, of course.
Just not for even a year, never mind long term.
**So that’s 12,791 deaths out of 201.5 million doses delivered? Still like my chances.**
Is that doses, or fully vaxxed folk?
bkmk
When I work...I have to wear a surgical mask..and a N-95...because I'm unVAXXED....It's BS.
Considering...Vaxxed people are getting the COVID...Why are they not required to wear two masks????
And VAXXED people are sheading the 19 when they get it.....
It's all a Flucked up mess....I've been around a sheet load of 19 pts...and right up in their grills too....
I feel fine...Pretty sure I have natural antibodies....I'm going to trust them. Not the Fed's....
May I suggest you do some diligent research on another “miracle man made drug” that was supposed to save lives, that was supposed to be oh, so much better than what our bodies were made to produce. It was touted so much that they gave it to all sorts of people for all sorts of reasons, and even fed it to the cows used for food.
As far as I know, it did not cause any immediate known deaths. But...it has had serious health implications for 3 generations, including the current one, although it was pulled from the market about 50 years ago. That included many deaths from a rare type of cancer that initially attacked more than one organ or system, widespread infertility in at least 2 succeeding generations, ADD, many life altering autoimmune disorders, depression, etc. The drug is Diethylstilbestrol, or DES for short.
The issue with the these shots is that we do not KNOW how they affect in the long run. We DO know they are causing more deaths in the first few days than is tolerable for any FDA drug. (The FDA started so that with much testing, we would have good assurance that the drug was both safe and effective). Data coming in shows these shots to be neither safe nor effective according to original FDA approval regime. And if you do your due diligence, there is good reason why an mRNA shot has not been approved in the last 20 years. Check the safety data from these studies yourself. Don’t rely on others. Then ask yourself, why is this one different? Even more so that there is NO long term safety study. (no - one year is not long term. Think much longer. Think multiple generations)
I used to work in the pharmaceutical industry as a scientist and long ago, new drug compounds were pulled and never even made it into human trials if there were any deaths or serious side effects in animal toxicity studies. This all began to change when marketing and money came into play when companies were allowed to start advertising their drugs. Research was cut short on many drugs at about the same time.
If you don’t want to believe me, that is fine. Watch their commercials. You will note all the side effects - many of which are some of the symptoms that the drug is supposed to eliminate. And many will say death can be a result. Shameful. I have shaken my head many times over the last several decades.
And if you don’t want to expend the time or effort on a little research (look at the original studies, not someone’s opinions of them). Research these days is easy. Or if you do your due diligence, and not just look at the articles that suit your point of view - that is fine. That is your choice.
My father and his family taught me that if you cannot argue either side of an issue from their original points of view, then you really don’t know what you are talking about. Over the last few decades as I watch on the sidelines on political and medical and whatever has 2 polar sides to it, I see the wisdom of his teaching more and more. I hope that I have taught my children the same. In the end run, though, God is sovereign in all things, and all things will be exposed to His light.
You may want to consider this a hill worth dying on if it comes to anti vax camps.
I am almost 70 and I can assure you that if it gets to that point I’m going to die before I enter a camp.
And with any luck I won’t die alone.
I am not so sure they “approved” it.
I read it as the FDA Did NOT fully approve the Pfizer shot as being reported! It only extended the Emergency use authorization!
https://www.fda.gov/media/150386/download
The FDA would approve injectable dog pee if that is what they were told to do. It is just another arm of corruption.
Oh all those hundreds of health care workers are just a bunch of anti vaxxers. 😏
Thanks for the link.
From your link, page 11, item “Y” spells it out clearly, product must be marked as not approved by the FDA.
Always with the feds, read the fine print. Professional liars they are.
You are not allowed to say that…c’mon man.. truth and freedom to utter it is so in the past…
“No, he’s saying that the FDA should not be cutting corners to approve the “vaccines”.
But it’s killing .000000000001 percent of people receiving it. How can we live with the danger?”
The FDA stopped the Swine Flu vaccinations after ONLY 36 deaths and 3 months into the vaccinations. “.000000000001 percent of people”
The media reporting/Repeating lies are just as guilty if not more. They have the responsibility to vet, to research, what they report.
All we did was look at the official document to find the truth.
So? This isn’t polio.
Only when the assertion is potentially libelous against a person who is not a public figure.
Once you realize the press does not have any ethics (athough it claims it must abide the rule you stated), you'll start to sort though stories differently. If the facts matter to you, then do your own research. The press LIES - all the time. "The snake." It is what it is.
You’re lucky because the polio vaccine gave over 200,000 people the polio
FDA< LOL. Follow the money. Who funds the FDA? Of course they would approve the drug. Gotta keep the pharmas making money.
Amazing that NO ONE has reviewed the autopsies performed so far or even requested further autopsies to actually see what the clot shot is doing to us.
FDA is a bunch of toadies looking for their next pay check.
If I was that girl I would have run away until they left the house
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