27 Experts Demand FDA ‘Get the Science Right’ Before Approving COVID Vaccines
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.
“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.
See more here: childrenshealthdefense.org
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nohomehere
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yes, it’s a jungle out there. More twists and turns.
but , just like global warming , the science has been high jacked by one world governance lobby.
The G7 today announces it wants a small global tax…just a bob or a tupence. just to compensate for the donated jabs .
we all know the decision making has been usurped by the institutions they claim are democratic !?
These usurper s couldn’t get theit trade agreements passed so they used biological wwarfare until we submit.
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Manjushri
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Ahh the global tax!
If they are suggesting it for the injection, then it must because they realise they cannot keep afloat the ‘CO2 causes global warming’ myth to encourage support of a global carbon tax.
A global tax would be a foundation stone for a global government.
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Nohomehere
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think digital crypto as a quick path to totalitarian tax. As votes seem to count less and less in elections such as the brexit deal postponed forever and biden becoming president and rejoining Paris accord or WEF’s you will own nothing and be happy all from a non elected group.. there is little selection available other than submission. Unless. …
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Alan
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I can understand the request for two years of follow up, but how can the risks be assessed if the placebo group no longer exists, which seems to be the case.
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Saeed Qureshi
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People do not realize that FDA and other similar organizations worldwide are not science organizations or authorities on science. Instead, they are administrators of medical and pharmaceutical practices. In this regard, medical and pharmaceutical professions are also not science professions either. Instead, they are users of science or its outcome. (http://www.drug-dissolution-testing.com/?p=3850, http://www.drug-dissolution-testing.com/?p=3870).
As an analogy, chefs prepare meals to make their customers happy and healthy. They hardly ever invent or manufacture the ingredients required to prepare the meal. Instead, they are dealt with by other groups, such as agriculture, farmers, manufacturers, etc. Similarly, the medical and pharmaceutical experts make their customers (patients) happy and healthy by providing the diagnosis and treatment using already well-established ingredients (tests and pharmaceuticals). They never develop or are trained to develop or invent the diseases and their treatments.
So if a request is made to FDA to correct the science, it is not a valid request. They cannot correct or fixed because science is not done there. The Petition, most likely, will sit there without any response, as is the case of my Petition (http://www.drug-dissolution-testing.com/?p=3217). Scientifically speaking, my Petition is far easier to understand and deal with than the safety and efficacy evaluation of vaccines, but lack of science and its practice at the FDA causing hindrance in moving ahead.
Perhaps a more appropriate Petition or request would be to seek the information on how vaccines have been developed and evaluated against the virus when isolated virus specimens are not even available. It is not possible to provide a valid answer to such a query. Therefore, the vaccine approval process may stop and science gets a chance to get fixed.
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