FDA Must Halt Approval for Pfizer CV Vaccines Immediately
Sign the petition and let the FDA know that approval of the Pfizer Vaccine must be halted immediately.
The FDA must halt approval for the Pfizer Covid-19 Vaccine Immediately. A company seeking a BLA (or full approval) for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials. As we have already seen numerous times, the Pfizer duo has not been effective in preventing or controlling the spread nor has it guaranteed immunity to Coronavirus and its variants.
In a citizens petition the efficacy and safety measures that must be met before serious consideration is given to granting a BLA/full approval of any COVID-19 vaccine was outlined...
"These measures include:
1. 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.
2. 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.
3. 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.
4. Completion of vaccine biodistribution studies from administration site and safety implications of mRNA translation in distant tissues.
5. Thorough investigation of all severe adverse reactions reported following COVID-19 vaccination, such as deaths, reported in the United States and global pharmacovigilance systems.
6. Assessment of safety in individuals receiving more than two doses.
7. 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.
8. 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.
A COVID-19 vaccine BLA should be approved when—and only when—substantial evidence demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient
population.
FDA Must Halt Approval for Pfizer CV Vaccines Immediately
Sign the petition and let the FDA know that approval of the Pfizer Vaccine must be halted immediately.
The FDA must halt approval for the Pfizer Covid-19 Vaccine Immediately. A company seeking a BLA (or full approval) for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials. As we have already seen numerous times, the Pfizer duo has not been effective in preventing or controlling the spread nor has it guaranteed immunity to Coronavirus and its variants.
In a citizens petition the efficacy and safety measures that must be met before serious consideration is given to granting a BLA/full approval of any COVID-19 vaccine was outlined...
"These measures include:
1. 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.
2. 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.
3. 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.
4. Completion of vaccine biodistribution studies from administration site and safety implications of mRNA translation in distant tissues.
5. Thorough investigation of all severe adverse reactions reported following COVID-19 vaccination, such as deaths, reported in the United States and global pharmacovigilance systems.
6. Assessment of safety in individuals receiving more than two doses.
7. 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.
8. 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.
A COVID-19 vaccine BLA should be approved when—and only when—substantial evidence demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient
population.