A group of 27 clinicians, researchers and advocates last week [June 3] filed an urgent Citizen Petition with the U.S. Food and Drug Administration (FDA) urging the agency not to prematurely grant full approval to any COVID vaccine.
“Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of U.S. residents, with global ramifications considering the international importance of FDA decisions,” the group said.
The FDA citizen petition process, described in Title 21 of the Code of Federal Regulations (21 CFR Part 10), allows individuals and community organizations to request the agency make changes to health policy. At any time, any “interested person” can request the FDA “issue, amend or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.”
In their petition, the group outlined many unanswered questions surrounding the efficacy and safety of COVID vaccines, and detailed how data must be collected before the FDA considers granting any vaccine full approval.
“We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure,” petitioners wrote.
In an op-ed published today in The BMJ, four of the petition’s signatories, writing on behalf of the group, said:
“The message of our petition is ‘slow down and get the science right — there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base — both pre- and post-authorization — is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.”
The petition states a COVID vaccine should be fully approved only when substantial evidence demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient population. The petitioners “respectfully” requested the FDA act on the petition by June 11. They plan to seek judicial relief if the petition is denied.
The FDA granted Emergency Use Authorization (EUA) to three COVID vaccines — Pfizer, Moderna and Johnson & Johnson (J&J) — allowing rapid and widespread vaccine rollout across the U.S. However, the EUAs were granted without a built-in expiration date, which means they can lawfully be distributed even after a “public health emergency” no longer exists.
The 20-page citizen petition and supporting documents are filed under Docket ID FDA-2021-P-0521 on regulations.gov. Anyone can comment on the petition, or read others’ comments, including the FDA’s official reply once it arrives.
Petitioners ask the FDA to implement eight efficacy and safety measures before granting a COVID vaccine full FDA approval:
- Complete at least two years of follow-up of participants originally enrolled in pivotal clinical trials, even if the trials were unblinded and now lack a placebo control. All vaccine manufacturer phase 3 trials were already designed with this planned duration.
- Prior to including in the list of populations for which a vaccine is approved, ensure there is substantial evidence that clinical effectiveness outweighs harms in special populations including: infants, children and adolescents; those with past SARS-CoV-2 infection; immunocompromised; pregnant women; nursing women; frail older adults; and individuals with cancer, autoimmune disorders and hematological conditions.
- Require thorough safety assessment of spike proteins being produced by body tissues following vaccine administration, and spike proteins’ full biodistribution, pharmacokinetics and tissue specific toxicity.
- Complete vaccine biodistribution studies from administration site and safety implications of mRNA translation in distant tissues.
- Require data of all severe adverse reactions reported following COVID vaccination, such as deaths, reported in VAERS and other pharmacovigilance systems.
- Assess safety in individuals receiving more than two doses.
- Include gene delivery and therapy experts in the Vaccines and Related Biological Products Advisory Committee (VRBPAC), in recognition of the fact that the novel COVID vaccines work on the premise of gene delivery, in contrast to conventional vaccines.
- Enforce stringent conflict-of-interest requirements to ensure individuals involved in data analysis and BLA-related decision-making processes have no conflict of interests with vaccine manufacturers.
The petitioners provided a rationale for each requested action and a list of what they said were invalid reasons for rushing full approval of COVID vaccines. They explained that approving COVID vaccines for the purpose of ensuring they are accessible after the public health emergency has ended, or in an effort to ensure adequate access to vaccines across the population, are two objectives that can be accomplished with current EUAs.
The group also said giving full approval to a COVID vaccine in an effort to pave the way for vaccine mandates or to bolster public confidence, were outside the scope of the FDA’s purview.
“Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of U.S. residents, with global ramifications considering the international importance of FDA decisions,” the group said.
Earlier this month, Children’s Health Defense Chairman (CHD) Robert F. Kennedy, Jr. and Dr. Meryl Nass, on behalf of CHD, filed a Citizen Petition with the FDA requesting the agency not only refrain from licensing COVID vaccines, but also immediately revoke the vaccines’ EUAs.
CHD submitted 72 references supporting the request for revocation and restraint. To read the full CHD petition text, download it from the FDA website or read the full petition here — then submit your comments using this form.
HD Editor’s Note: Why Is This News Biblically Relevant?
Leo Hohmann in a recent article quoted Dr. Peter McCullough, who is “the most cited medical doctor on COVID-19 treatments at the National Library of Medicine.” McCullough expressed his shock that coronavirus vaccines have continued to be administered despite the shocking death rate of the shot:
One of the world’s most prominent medical doctors with expertise in treating COVID-19 has gone on the record with a scathing rebuke of the U.S. government’s approach to fighting the virus. He says the government’s strategy, carried out in cooperation with the Bill and Melinda Gates Foundation and the United Nations World Health Organization, has resulted in tens of thousands of unnecessary deaths and is now being followed up with thousands more deaths caused by a mass-injection program.
Recently, McCullough stated that whistleblowers have come forward from inside the CDC saying that vaccine deaths could be as high as 50 thousand in the United States.
One might expect these numbers would trigger an exhaustive investigation from the U.S. Food and Drug Administration. But the opposite has occurred. According to McCullough, the government has taken what amounts to a passing glance at the alarming numbers and dismissed them with a bare minimum of scrutiny.
“A typical new drug at about five deaths, unexplained deaths, we get a black-box warning, your listeners would see it on TV, saying it may cause death,” McCullough said. “And then at about 50 deaths it’s pulled off the market.”
The U.S. has a precedent for this. In 1976 during the Swine Flu pandemic the U.S. attempted to vaccinate 55 million Americans, but at that point the shot caused about 500 cases of paralysis and 25 deaths.
“The program was killed, at 25 deaths,” McCullough said.
Compare that type of response to the government’s reaction to much higher reported death numbers related to the Moderna and Pfizer shots and the contrast is alarming, McCullough said, especially when the shots have not even been granted full FDA approval and are only being allowed on the market under an Emergency Use Authorization.
McCullough has also explained that despite his respected medical credentials, he would not be able to “come out and say all this on national TV today,” or “communicate it to government agencies,” or even with many of his “propagandized” medical collegues:
“Now I can’t come out and say all this on national TV today or at any time,” he continued. “But, what we had learned over time is that we could no longer communicate with government agencies. We actually couldn’t even communicate with our propagandized colleagues in major medical centers, all of which appear to be under a spell, almost as if they are hypnotized right now.”
Since the beginning of the Covid-19 “pandemic,” those seeking to advance this agenda have claimed to follow the science. Those claims have been continuously dismantled, as doctors, experts, and journalists are routinely silenced.
These are not isolated incidences of censorship. Doctors who have spoken out against the chosen narrative surrounding the coronavirus are having their voices snuffed out at an unprecedented rate.
This vast control of information the public is allowed to receive is also not isolated to big tech companies such as Google, Twitter, Facebook, and others. This censorship is also being perpetrated by health officials and hospitals threatening their doctors who publicly seek to voice their concerns.
In 2 Timothy 3:1, we are told that in the last days, perilous times would come. During this time, the apostle Paul explains that people of “corrupt minds” would “despise” and “resist the truth” (2 Timothy 3:8-9).
Terry James, in his recent article, “Foreshadowing the Mark,” explained that the “over-the-top clamor for vaccination compliance” is setting the stage for Biblical prophecy to be fulfilled:
If there is one element of the so-called Covid-19 pandemic that presages Tribulation era Bible prophecy, it is the hue and cry, the over-the-top clamor for vaccination compliance. I say so-called pandemic, because statistics have long since documented that this virus nowhere near reaches the level of previous true pandemics.
Again, I address the topic of the virus with the understanding that it is serious. All such infections are serious and must be dealt with care and common sense. However, it is the common sense aspect that is missing in this so-called pandemic. It is a manufactured pandemic with a biblically prophetic attachment that should not be missed by the spiritually-attuned believer.
Many who look critically at this unprecedented drive to make all on earth compliant with vaccine acceptance believe it is all setting up worldwide embrace of the marks and numbering system of Revelation 13:16-18.—i.e., it is all a blueprint for control of the populations on earth during the time of Antichrist’s rule.
The current vaccinations for COVID, or for any other disease, is not that prophesied mark. It will come on the scene during the Tribulation, after the Rapture of the Church.
Whether you choose to take the vaccine or choose to resist taking it, the process, whether beneficial or detrimental in terms of human health, itself is, without question in my mind, part of a control process being implemented by the powers and principalities of Ephesians 6:12.
