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,
###
And as Trump keeps recommending the vaccines, not standing up agaist the vaccine mandates (saying you have your freedom was a weak statement in my opinion) - his chances of being preisdent again are getting slimmer.
Didn't have a choice. When I was a month or so old I got vaccinated for polio and other illnesses. Nobody asked me.
It likely why the CDC and FDA staffs don’t mandate it for their staffs
Why doesn’t Johnson address this?
Republicans are so lame
Do you do the same with those promoting the anti-vax position?
The VAERS data is for the US. Europe has its own. Nations that are not part of either, maintain their own adverse reaction counts. Just the UK shows a much larger percentage than the politicized US system.
I personally know the same number of people who died with Covid as have died from the jab - I know - personal anecdote- but to pretend these genetic therapies are totally safe is beyond ridiculous.
Come one, come all...get your kill shot TODAY!
Depending on your age, that polio vaccine had probably been widely used for DECADES before it was administered to you.
I got the Pfizer vax and didn’t even get a swollen arm, no side effects whatsoever. My daughter got the same thing and it took her out of commission for a whole day. She only got it because she’s going to Hawaii in September, and didn’t want to waste time being in quarantine. She’s not getting the second shot. I haven’t decided about that.
Nobody has been pushing that crap on me.
So that's 12,791 deaths out of 201.5 million doses delivered? Still like my chances.
I got the polio shot the first year it was out. In our town, a couple of kids got polio and suffered severe consequences. One, a high school basketball star, was crippled for life.
He should make it clear that the health officials should be aware of these, and that if they are trying to hide or cover them up, then there will be Investigations in the future
Individual cases can be ignored as just being anecdotes. Hundred fold increases in overall deaths reported can be ignored because we don’t know details of each case. All data showing the danger of jabs can thus be ignored, and is never ever valid.
Very helpful.
.
I'm retired now, but in all my years of working, I was never once asked to verify that I had been vaccinated for smallpox, polio, rubella, tb, influenza etc. I guess it was assumed from going to public schools. I believe many people home schooled because they believed that the vaccines were contributing to autism, so it is not a safe assumption that everybody is vax'd . I just think it's strange now that you have to prove vax status when it never has been an issue before.
There is hard, incontrovertible evidence of serious side effects including serious, irreversible damage and death.
Here's what's wrong... "The LOVE of MONEY is the ROOT of EVIL"
after seeing Biden and "Fuci" lie again and again and nothing happen with a stolen election if you trust the govt, I question your common sense or is it your agenda?
this fiasco like Afghanistan will not end well.
A primary argument of health care workers who are avoiding the vaccine is that it is “experimental”. Valid point.
Once it is declared approved by the FDA, the hospitals will have a stronger argument to demand they get the shot to continue employment. An “approved” drug is much easier to mandate than an “experimental” drug.
That is the crux of both - the attempt to delay by the GOP to avoid mandates and the attempt for the bureaucrats to strengthen their arguments for vaccine mandates.
I am vaccinates, but (a) seems they are not so effective in avoiding COVID for as long as advertised with the number of breakthrough illnesses, and (b) the harm they seem to do to young healthy people (mainly men) regarding their hearts is rare, but definitely worse than the sickness.
Bottom line, I’m happy I got the shot because even if I get a breakthrough case, it should not hospitalize or kill me. Could they be lying? Who knows, but over 189 million people are vaccinated; and it seems to be working. Not perfect, but nothing is. Lots of “cases” but not many deaths among the vaccinated (except the very old or with serious comorbidities).
What is missing - antibody testing! Why the hell don’t we have widespread antibody testing? If you have antibodies, you get a pass. Crazy.
Its almost like they have stock in the vaccine companies!
Didn't have a choice. When I was a month or so old I got vaccinated for polio and other illnesses. Nobody asked me.
That's between you and your parents. Now that you're promoting the Jim Jones Jab as an adult, glad to see you volunteering for strangers to decide any healthcare treatment they wish for you.
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