27 Experts Launch Petition Demanding FDA Slow Down
And Get The Science Right Covid-19 Vaccines Masks
Direct Link https://newtube.app/user/AllTheWorldsAStage/Vmg3QCv
A group of 27 prominent health experts and scientists are inviting public comment on their petition calling on the FDA to withhold full approval of COVID vaccines until efficacy and safety measures are met.
A group of 27 clinicians, researchers and advocates last week 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.
The petition author and co-authors include:
- Linda Wastila, BSPharm, MSPH, PhD and professor at University of Maryland School of Pharmacy
- Peter Doshi, PhD, associate professor at University of Maryland School of Pharmacy
- Patrick Whelan, MD, PhD associate clinical professor of pediatrics David Geffen School of Medicine at UCLA
- Hamid A. Merchant, BPharm, MPharm, PhD, RPh, CQP, PGCertHE, FHEA, SRPharmS and subject leader department of pharmacy at University of Huddersfield
- Donald W. Light, PhD and professor of comparative health policy and psychiatry at Rowan University School of Osteopathic Medicine
- Florence T. Bourgeois MD and associate professor of pediatrics at Harvard Medical School
- Robert M. Kaplan, PhD and distinguished research professor UCLA Fielding School of Public Health
- Peter A. McCullough, MD and professor at Texas A & M College of Medicine
- Anthony J Brookes, PhD and professor of genetics University of Leicester
- David Healy, MD, FRCPsych and professor of psychiatry McMaster University Ontario, Canada
- Byram Bridle, viral immunologist and associate professor at University of Guelph, Ontario
- Kim Witczak, founder and CEO of Woodymatters and global drug safety advocate
- Christine Stabell Benn, MD, PhD and professor of global health at University of Southern Denmark
- Matthew Herder, JSM, LLM, Director, Health Law Institute at Dalhousie University Nova Scotia, Canada
- Tom Jefferson, MD, MRCGP FFPHM, British epidemiologist who works with the Cochrane Collaboration, advisor to the Italian National Agency for Regional Health Services and is senior associate tutor at University of Oxford
- Peter Collignon, infectious disease physician, microbiologist at Canberra Hospital and professor at the Australian National University Medical School
- Peter C. Gøtzsche, Professor, DrMedSci, MD, MSc Director Institute for Scientific Freedom Copenhagen, Denmark
- Peter Aaby, MSc, DMSc, Head of Bandim Health Project, Guinea-Bissau University of Southern Denmark
- Ulrich Keil, MD, MPH, PhD, FRCP professor emeritus University of Münster, Germany
- Juan Erviti, PharmD, PhD Unit of Innovation and Organization Navarre Health Service, Spain
- Iona Heath, CBE FRCGP and past president of the Royal College of General Practitioners London, UK
- Joseph A. Ladapo, MD, PhD associate professor of Medicine David Geffen School of Medicine at UCLA
- Barbara Mintzes, BA, MSc, PhD, associate professor, School of Pharmacy at the University of Sydney, Australia
- Huseyin Naci, MHS, PhD associate professor of Health Policy London School of Economics and Political Science
- Angela Spelsberg, MD, Comprehensive Cancer Center Aachen, Germany
- Erick Turner, MD, associate professor of psychiatry at Oregon Health & Science University
- Allyson M Pollock, MBChB, FRCPH, FRCP, FRCGP, clinical professor of Public Health Institute of Health and Society, Newcastle University and director of the Newcastle University Centre for Excellence in Regulatory Science.
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.
Back in 2009 they had another fake pandemic.
This is in one of the reports from back then.
A Quote from one of the reports. Hasty testing and preparation of the vaccine. Baxter Intl applied for the patent in 2008, long before the outbreak. How does that work? “The Baxter vaccine, called Celvapan, has had fast track approval. It uses a new vero cell technology, which utilizes cultured cells from the African green monkey. This same animal tissue transmits a number of vaccine-contaminating viruses, including the HIV virus.
“The Baxter company has been associated with two deadly scandals. The first event occurred in 2006 when hemophiliac components were contaminated with HIV virus and injected in tens of thousands of people, including thousands of children. Baxter continued to release the HIV contaminated vaccine even after the contamination was known.
“The second event occurred recently, when it was discovered that Baxter had released a seasonal flu vaccine containing the bird flu virus, which would have produced a real world pandemic, to 18 countries. Fortunately, astute lab workers in the Czech Republic discovered the deadly combination and blew the whistle before a worldwide disaster was unleashed.
Go HERE for the rest of the reports. Would they put something in vaccines to make you sick? Yes is the answer to that one.
More on the 2009 Fake pandemic and the adverse effects of the vaccines.
The Kenyan government denies there is anything wrong with the vaccine, and says it is perfectly safe.
The Kenya Catholic Doctors Association, however, saw evidence to the contrary, and had six different samples of the tetanus vaccine from various locations around Kenya sent to an independent laboratory in South Africa for testing.
The results confirmed their worst fears: all six samples tested positive for the HCG antigen. The HCG antigen is used in anti-fertility vaccines, but was found present in tetanus vaccines targeted to young girls and women of childbearing age. Dr. Ngare, spokesman for the Kenya Catholic Doctors Association, stated in a bulletin:
“This proved right our worst fears; that this WHO campaign is not about eradicating neonatal tetanus but a well-coordinated forceful population control mass sterilization exercise using a proven fertility regulating vaccine. This evidence was presented to the Ministry of Health before the third round of immunization but was ignored.”
Dr. Ngare brought up several points about the mass tetanus vaccination program in Kenya that caused the Catholic doctors to become suspicious:
Dr. Ngare told reporters that several things alerted doctors in the Church’s far-flung medical system of 54 hospitals, 83 health centres, and 17 medical and nursing schools to the possibility the anti-tetanus campaign was secretly an anti-fertility campaign.
Why, they ask does it involve an unprecedented five shots (or “jabs” as they are known, in Kenya) over more than two years and why is it applied only to women of childbearing years, and why is it being conducted without the usual fanfare of government publicity?
“Usually we give a series three shots over two to three years, we give it anyone who comes into the clinic with an open wound, men, women or children.” said Dr. Ngare.
But it is the five vaccination regime that is most alarming. “The only time tetanus vaccine has been given in five doses is when it is used as a carrier in fertility regulating vaccines laced with the pregnancy hormone, Human Chorionic Gonadotropin (HCG) developed by WHO in 1992.”
UNICEF: A History Of Taking Advantage Of Disasters To Mass Vaccinate
It should be noted that UNICEF and WHO distribute these vaccines for free, and that there are financial incentives for the Kenyan government to participate in these programs. When funds from the UN are not enough to purchase yearly allotments of vaccines, an organization started and funded by the Bill and Melinda Gates Foundation, GAVI, provides extra funding for many of these vaccination programs in poor countries. (See: Bill & Melinda Gates Foundation Vaccine Empire on Trial in India.)
Also, there was no outbreak of tetanus in Kenya, only the perceived “threat” of tetanus due to local flood conditions.
These local disasters are a common reason UNICEF goes into poorer countries with free vaccines to begin mass vaccination programs.
Last year UNICEF began a similar mass vaccination program with 500,000 doses of live oral polio vaccine in the Philippines after a Super Typhoon devastated Tacolban and surrounding areas. This was in spite of the fact there were no reported cases of polio in the Philippines since 1993, and people who have had the live polio vaccine can “shed” the virus into sewage systems, thereby causing the actual disease it is supposed to be preventing.
A very similar mass vaccination with the live oral polio vaccine occurred among Syrian refugees in 2013, when 1.7 million doses of polio vaccine were purchased by UNICEF, in spite of the fact that no cases of polio had been seen since 1999. After the mass vaccination program started, cases of polio began to reappear in Syria.
It seems quite apparent that UNICEF and WHO use these local disasters to mass vaccinate people, mainly children and young women. Massive education and propaganda efforts are also necessary to convince the local populations that they need these vaccines. Here is a video UNICEF produced for the tetanus vaccine in Kenya. Notice how they use school teachers and local doctors to do the educating, even though the vaccines are produced by western countries.
At least in Kenya, doctors are acting and taking a stand against what they see as an involuntary mass sterilization campaign designed to control the population of Africans.
https://www.africanglobe.net/africa/mass-sterilization-kenyan-doctors-find-anti-fertility-agent-tetanus-vaccine/
Blanket Surveillance Coming Online
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