Saturday, May 22, 2021

Citizen's Petition to the FDA asking it to revoke all Covid vaccine authorizations

The Citizen Petition is quite long, but it is a detailed criticism of the Covid vaccines themselves and the improper processes FDA has used to authorize their use.  It shows that the standards required to issue an EUA were not met, and shows that the standards for licensing these vaccines are unmet. 

A Citizen Petition is a legal document to which the FDA must respond. I am a coauthor, with colleagues who worked with me on the anthrax vaccine mandates, and Children's Health Defense attorneys. We hope many thousands of people will read our petition, to be better informed about how the laws have been ignored, how much information on the vaccines and their side effects has been hidden, and how what we do know is frightening.  We need everyone who cares about this issue to provide a comment to the FDA.

Here is how you can do this.  You must go to the government website and download the Petition before you can read it. Click on the pdf logo where it says "Petition from Scientific Advisory Board..." To enter a comment, there is a blue button on the same page that takes you to the comment site. We have over 11,000 comments entered already, in just 3 days    

I am finding it hard to write about a document that means a lot to me.  It may provide a stepping stone to clarity about Covid, the vaccines, the falsehoods that have been promulgated by federal agencies.  It may save us from the tyranny of forced injections containing what Moderna's Chief Medical Officer Tal Zaks called, "the software of life."

The FDA is obliged to respond to all the points we have made.

Here is a summary written by Children's Health Defense of what the Petition is about:

Children's Health Defense Petition:

Your help is crucial. 
On May 16, Robert F. Kennedy, Jr. and Meryl Nass, MD, on behalf of Children’s Health Defense (CHD), took a landmark step in the COVID crisis that has irrevocably changed billions of lives around the globe by filing a Citizen Petition with the U.S. Food and Drug Administration (FDA) to withdraw COVID-19 vaccines from the market. 
Your comment now on the FDA petition is vital in preventing further injuries and deaths from these experimental medical products. Let your voice be heard! 
The actions of the FDA affect global health policy. This filing allows all of us—not just those in the United States, but people from around the world—to speak directly to the U.S. government by commenting on the petition. 
Specifically, the petition calls upon the FDA to: 

·         Revoke the Emergency Use Authorizations (EUAs) for COVID vaccines 
·         Refrain from licensing COVID vaccines 
·         Disallow the participation of minors in COVID vaccine trials 
·         Immediately revoke all EUAs permitting vaccination of minors 
·         Revoke its tacit approval of pregnant women receiving COVID vaccines 
·         Immediately amend its existing guidance for the use of chloroquine drugs, ivermectin, and any other safe and effective drugs against COVID. 

The FDA petition was imperative as our government health agencies continue to ignore the astonishing numbers of deaths and injuries being reported to the U.S. Health and Human Services (HHS) Vaccine Adverse Events Reporting System (VAERS). Updated each Friday, yesterday’s data release reports 227,805 adverse events and 4201 deaths following vaccination with COVID-19 vaccines from December 14, 2020 through May 14, 2021. Alarmingly, a 2010 HHS study found that less than 1% of adverse events are ever reported to VAERS. Despite this, government agencies at local, state and national levels continue to promote uptake of these vaccines. These agencies are joined by mainstream media, celebrities, and even the White House in calling for people of all ages to just "get the shot" despite the very real risk of injury and death. 

All COVID-19 vaccines currently being administered were rushed through the Emergency Use Authorization (EUA) process even as doctors around the world are citing viable treatment options for COVID that are inexpensive and readily available. EUA status is intended for use only when effective treatment options can’t be found. Clearly, this is not the case with COVID. 

We are asking you to comment on the FDA petition now and urge the government not to mandate or license COVID vaccines. Please forward this email to all of your friends and relatives so they can comment too. If some of them are still undecided regarding the safety of COVID vaccines, please share this crucial information with them: 

We need to immediately stop the push for mandates, especially those aimed at children. The experimental COVID vaccines are already being recommended for 12-15-year-olds. It is only a matter of time before they recommend or mandate this vaccine for even younger children—including infants.
Please add your comment to the FDA petition now. 

Below is a Defender article about the Petition. We hope to garner as many comments as possible.  The number (and quality) of comments can make a huge difference in terms of the actions FDA takes.  Please, at least give the document a glance.

Amid growing safety concerns, Robert F. Kennedy, Jr. and Dr. Meryl Nass, on behalf of Children’s Health Defense (CHD), filed a Citizen Petition with the U.S. Food and Drug Administration (FDA) asking the agency to immediately revoke the Emergency Use Authorizations (EUAs) for COVID vaccines and to refrain from licensing them.

Millions Against Medical Mandates (MAMM), a coalition of health freedom organizations and individuals, joins CHD and other vaccine safety and health freedom groups in inviting the public, including healthcare workers, parents and military members, to submit comments on the petition.

CHD compiled and submitted 72 references supporting the request for revocation and restraint. To read the full petition text, download it from the FDA website or read the full petition here — then submit your comments using this form.

According to the most recent Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System data, there have been 192,954 reported adverse events following COVID vaccination, including 4,057 deaths between Dec. 14, 2020 and May 7, 2021.

These numbers stand in stark contrast to those reported following the aborted 1976 swine flu vaccine campaign that ended abruptly following approximately 30 reported deaths and 400 cases of Guillain–Barré syndrome.

Citing the extremely low risk to children from COVID, the petition calls on the FDA to immediately refrain from allowing minors to participate in COVID vaccine trials and to immediately revoke all EUAs permitting vaccination of children under 18.

“It’s time for the FDA to make a dramatic course correction before more deaths and injuries occur,” said Maureen McDonnell, MAMM founder.

The petition also urges the FDA to revoke its tacit approval for pregnant women to receive COVID vaccines.

The law stipulates that to grant EUA status, no other effective intervention may exist. The petition calls upon the FDA to immediately amend its existing guidance for the use of chloroquine drugs, ivermectin and any other safe and effective drugs against COVID.

“It’s time for the FDA to make effective COVID treatments available and to revoke the vaccine EUAs,” said CHD President and General Counsel Mary Holland. “It’s shocking that the FDA has ignored the unprecedented reports of injuries and deaths for five months.”

CHD and MAMM are asking the FDA to take these seven actions:

  1. FDA should revoke all EUAs and refrain from approving any future EUA, NDA [new drug application] or BLA [biologics license application] for any COVID vaccine for all demographic groups because the current risks of serious adverse events or deaths outweigh the benefits, and because existing, approved drugs provide highly effective prophylaxis and treatment against COVID, mooting the EUAs.
  2. Given the extremely low risk of severe COVID illness in children, FDA should immediately refrain from allowing minors to participate in COVID vaccine trials, refrain from amending EUAs to include children, and immediately revoke all EUAs that permit vaccination of children under 16 for the Pfizer vaccine and under 18 for other COVID vaccines.
  3. FDA should immediately revoke tacit approval that pregnant women may receive any EUA or licensed COVID vaccines and immediately issue public guidance to that effect.
  4. FDA should immediately amend its existing guidance for the use of the chloroquine drugsivermectin and any other drugs demonstrated to be safe and effective against COVID, to comport with current scientific evidence of safety and efficacy at currently used doses and immediately issue notifications to all stakeholders of this change.
  5. The FDA should issue guidance to the secretary of the defense and the president not to grant an unprecedented presidential waiver of prior consent regarding COVID vaccines for service members under 10 U.S.C. § 1107(f) or 10 U.S.C. § 1107a.
  6. The FDA should issue guidance to all stakeholders in digital and written formats to affirm that all citizens have the option to accept or refuse administration of investigational COVID vaccines without adverse work, educational or other non-health related consequences, under 21 U.S.C. § 360bbb-3(e)(1)(a)(ii)(III) 1 and the informed consent requirements of the Nuremberg Code.
  7. Pending revocation of COVID vaccine EUAs, FDA should issue guidance that all marketing and promotion of COVID vaccines must refrain from labeling them “safe and effective,” as such statements violate 21 U.S.C. § 360bbb-3.

The petition is available for review and comment. CHD urges parents, healthcare practitioners, military members and others to comment and to share the comment link with friends and colleagues.


yvette said...

Important new paper shows the spike protein and S1 both circulating freely in the blood after vaccination. This was not supposed to happen - first good evidence that how the vaccines are "supposed" to work does not simply line up with the complex reality of biology.

"The mechanisms underlying release of free S1 and the subsequent detection of the intact spike protein remain unclear and require further studies." We also need to learn a lot more about the biological impacts of the spike and S1 protein.

Anonymous said...

Dr. Nass, thank you for your endorsement of the Citizens Petition to stop these dangerous gene-editing vaccines. I have signed it.

I hope there is a related action to file for an Emergency Injunction to suspend the vaccines immediately,
as I’m sure FDA says it needs time to consider the Petition - meanwhile more people are dying or being sterilized from these gene-editing vaccines. There are also many other Doctors also calling for a halt.

My Amicus Brief to the court would offer the perspective that ~60% of NIH, CDC, and FDA employees have REFUSED to take the injection - based on direct testimony in front of the US Senate. It’s been said that 100% of Moderna and Pfizer employees have also REFUSED to take the injection, most especially the senior management teams and their extended families. What do they know that is being withheld from the rest of the world.

At the same time, I would explain to the judge that the mRNA technology based injections ARE NOT VACCINES under FDA regulations. Thus this whole EUA was based on medical fraud, driven by evil people. There is extensive evidence that these gene-editing injections represent a massive depopulation / sterilization program, that is happening in the USA and around the world.

Lastly, I would ask the judge to issue a bench warrant for the arrest of Gates, Fauci, and the CEOs of Moderna and Pfizer, just for starters - and then round up all the supporting cast.

Anonymous said...

Dr. Nass, have you seen this yet?

Dr. Walensky On The COVID-19 Vaccine, Pregnancy, And Fertility

My god I think she has sold her soul to the devil.

Anonymous said...

Have you seen the info in the DOE email links below?
I started to review the first one: Covid 19 Vaccine: Helping to Educate Maine – YouTube
I got out to 3 mins 47 sec and heard the presenter...(a pharmacist not an md)... state: “Covid-19 vaccines are being held to the same safety standards as all vaccines.”
That is not true. The proponents for the jab are not telling people that the shot is NOT a vaccine as defined by medical standards and requirements, and is NOT currently approved by the a result of the lack of testing the ‘jab’ results in emergency use only.
Why is DOE presenting information to the public that is not completely true and accurate? The credibility of DOE is challenged; meaning any future information is not to be believed; it is to be verified first. L

Anonymous said...

Thanks for the push on this Petition. I have made supportive comments:
--billed as "safe and effective"
--given without consultation to pregnant women
--ignored Ivermectin and now Fluvoxamine as effective treatments
--ruined control arm of study

Thanks for your guidance in this.

Anonymous said...

Dr. Nass, there is another key point that supports the termination of EUA for these mRNA gene-editing vaccines - permanently.

There has been a stunning fact reported in a paper titled “Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19”, from the International Journal of Vaccine Theory, Practice and Research.


The injections are effectively a different product, manufactured in a very different method than the product used in the Trials - the data from which the FDA reviewed and evaluated to issue the EUA. This is medical fraud. The new process used for creating what is going into the arms of people is multi-step, unclean, derivative process, that results in a product that is very different and significantly prone to causing death and injury to recipients. Again, this is medical fraud.

The FDA itself is guilty of GROSS MISCONDUCT. The resultant EUA is invalid. Not only are the manufacturers liable for ALL death and injury caused by this medical fraud, but the FDA itself is guilty as a co-conspirator and is also liable for ALL death and injury caused by their misconduct.

zarembka said...

Meryl, Thanks for all your work on this filing! I hope it cannot be ignored and that an itemized and careful response is received.

Iowamom66 said...

Dr. Ness, thank you for taking this upon yourself to help so many people. As stated in some many comments above these are Not vaccines but a shot that leads to death & fatal reactions to human kind. It must be STOPPED. AGAIN thank you for everything your doing. In God's name we pray.

Anonymous said...

Thank you for doing this. I hope it works. But I suspect that only a lawsuit and (hopefully) the Supreme Court will be able to stop this.

Glenna Sue Dickinson said...

Glenna Sue Dickinson said...

Glenna Sue Dickinson said...

lynnbrad said...

Dr Nass; Thanks eternally for all your hard work on behalf of humanity. And for the clarification on how to proceed with commenting. I will do so today. Finished reading the petition yesterday and am forwarding to many. Lynn Bradbury