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,
###
Right on cue, FDA approves one of the three jabs.
I guess I’d better mentally prepare for the unvax concentration camp.
So is Johnson recommending the vaccinations stop?
There is hard, incontrovertible evidence of serious side effects including serious, irreversible damage and death.
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?
Why hasn’t anyone subpoenaed the heads of health systems around the nation to find out if they are censoring what their employees can tell their patients...
Anyone who wants the vaccine can get one under the current EUA’s.
The only reason for formal approval is to provide leverage for mandates.
People are dying and becoming seriously injured from these vaccines. They were designed against the alpha strain and are becoming more useless by the day. To approve such a medication in a star chamber is a crime against humanity.
The situation right now is one of coordination between government and business.
Employers of varying sizes Fox News being one example are now ascertaining the vaccination status of employees.
They are prepping for vaccinate mandates of their own likely in coordination with federal rule making maybe OSHA or someone else.
Private employers on their own mandating vaccines likely backed up by federal government rules imposing vaccination on their workforces.
Senator, you and your fellow members of Congress had better get on the ball and do something to stop vaccination mandates.
Actually if they were approved then they would immediately have to pull them because of the adverse reactions including death.
Your trust in the CDC numbers is like trusting the death count that China released.
The CEO of this company and employees refused the shot?
Well then step up. Glad to see you volunteer for ANY healthcare treatment OTHERS decide for you.
I always ask anyone who gets online and peddles these “vaccines” through cyberspace to identify themselves by name and field of expertise … and then assure me that there are no long-term adverse effects from the sh!t they’re pushing.
I'm taking his numbers and dividing that by the half billion or so vaccinations that have taken place in the U.S., UK, and EU alone. I probably missed a couple of decimal places at that.
Not understanding the rush to get an unproven, non-approved experimental injection involving a new technology (mRNA), for something that has a 99% + recovery rate, while wagging one’s finger at those who refuse. All while low-cost therapeutics and prophylaxsis are proven to work (ivermectin, hydroxychloroquine, etc).
A critical aspect of the Emergency Use Authorization for vaccines is for there to be no other viable treatments for covid. That is why Ivermectin and Hydroxychloroquine have been smeared as much as they have. Also include the profit incentive of mass injections vs a less than $1 per pill treatment. The U.S. medical system follows the dollars, not the science.
The mRNA vaccine has killed more people than all previous vaccines combined. The swine flu vaccine was halted in 1976 In 9 states after 3 people died.
This is not a vaccine. The jab using mRNA delivers mRNA in a nano lipid or fat envelope to a cell. It’s a medical device designed to stimulate a cell into becoming a pathogen creator by creating the known to be harmful spike protein.
Vaccine is a defined term in law and under CDC and FDA standards. A vaccine has to stimulate an immunity in the person receiving it. And it must also disrupt transmission.
That’s not what this is. Even the drug manufacturers admit the jab or its mRNA does not stop transmission.
The jab is a treatment, but if it’s discussed as a treatment it would not get the sympathetic ear of public health officials because people would ask what other treatments there are. And alternative treatments would hamper FDA’s ability to issue emergency approval of the jabs.
Defining the narrative with the term vaccine is a sucker punch to open and free discourse. “Vaccine” throws the discussion into one of pro/con vaccine. The jab is a mechanical device in the form of a very small packet of technology inserted into the human system to activate the cell to become a pathogenetic spike protein manufacturing site.
No basis exists to stipulate this is a vaccine. Simply put, this is a chemical pathogen device meant to unleash chemical pathogen production within a cell. It’s a medical device, not a drug. The jab is not a living or biologic system, but rather a physical technology that just happens to come in the size of a molecular package.
Follow the money ....
Gates buys and pushes vaccines
about 30% are hesitant to take the vaccine.
Gates buys a testing company.
CDC then pulls the plug on the current Covid test (which could not distinguish between Covid and Influenza).
Now the government requires the vaccine hesitant to get “tested” .
.... who makes the money in this scenario?
As it turns out, we now find the vaccines do not work as advertised. “Safe and effective” is now becoming “safe for some and not especially effective after 6 months”.
i wonder how many fewer conceptions/births since the shot was rolled out?
Btt🔝📌
Mystery Babylon
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