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.
A group of 27 clinicians, researchers, and advocates has 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.
In their petition, as reported by the Children’s Health Defense (CHD) news site, 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.
The petition dated June 1 states that a Covid vaccine should be fully approved only when substantial evidence demonstrates that the benefits of a specific product outweigh the harms for the indicated, recipient population. The petitioners requested the FDA to act on the petition by June 11. They plan to seek judicial relief if the petition is denied.
The CHD news site reports that 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 when a “public health emergency” no longer exists.
Meanwhile, a leading Fox News commentator, Tucker Carlson, said in his TV show that pushing Covid vaccines on young people is “reckless” because we don’t know the long-term effects. “Anyone who claims to know is lying,” he said. [ You can click here to watch Carlson’s program. ]
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.
In this petition, the petitioners outline efficacy and safety measures that must be met before serious consideration is given to granting a Biologics License Application (BLA) of any Covid-19 vaccine. These measures include:
- Completing at least 2 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.
- Ensuring, prior to including in the list of populations for which a vaccine is approved, that there is substantial evidence of clinical effectiveness that outweighs harms in special populations such as: infants, children, and adolescents; those with past SARSCoV-2 infection; immunocompromised; pregnant women; nursing women; frail older adults; and individuals with cancer, autoimmune disorders, and hematological conditions.
- Requiring thorough safety assessment of spike proteins being produced in-situ by the body tissues following vaccine administration, and spike proteins’ full biodistribution, pharmacokinetics, and tissue specific toxicity.
- Completion of vaccine biodistribution studies from administration site and safety implications of mRNA translation in distant tissues.
- Thorough investigation of all severe adverse reactions reported following Covid-19 vaccination, such as deaths, reported in the United States and global pharmacovigilance systems.
- Assessment of safety in individuals receiving more than two doses.
- Inclusion of 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.
- Enforcing 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 argue that a Covid-19 vaccine BLA should be approved when—and only when—substantial evidence demonstrates that the benefits of a specific product outweigh the harms for the indicated, recipient population.
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