The FDA must revoke 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 citizen's 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. This means that the following are invalid reasons to approve a COVID-19 vaccine: ● To ensure vaccines are accessible after the public health emergency has ended. COVID19 vaccines granted an emergency use authorization (EUA) can be lawfully used after the expiry of the SARS-CoV-2 public health emergency declaration. (This is made clear by the many products for Ebola and Zika viruses which still have active EUAs.1) ● To ensure adequate access to vaccines across the population. A BLA is not necessary to assure access to COVID-19 vaccines. Unlike normal licensing, in which widespread use of a drug or vaccine follows approval, EUAs for COVID-19 vaccines have enabled, and continue to enable, their widespread use. Ensuring access to vaccines is irrelevant to the considerations for issuance of a BLA because broad access to COVID-19 vaccines has already been accomplished. ● To enable vaccine mandates. Consideration of vaccine mandates is outside of FDA’s purview. Furthermore, a mandate should only be considered once the evidentiary conditions are met for a BLA (demonstrating that benefits outweigh harms). ● To bolster public confidence. Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA’s purview. Approving before substantial evidence that population-based evidence of clinical effectiveness is superior to harms may contribute to public wariness and hesitancy, not only about COVID-19 vaccines, but other vaccines and public health authorities more broadly. An approval may bolster public confidence, but it is not a valid reason to approve. Regardless of any legitimacy of each of the above reasons, none provides grounds to approve a COVID-19 vaccine. The widespread use of a COVID-19 vaccine under EUA, particularly for a limited amount of time, also is not a valid reason to approve a product. Even if vaccine recipients are followed up within observational studies, such studies may have important design biases and flaws, and their conclusions, especially concerning clinical effectiveness outcomes, may not be reliable. Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of US residents, with global ramifications considering the international importance of FDA decisions. It also could set a precedent of lowered standards for future vaccine approvals."

There have been multiple cases of injuries due to the Pfizer vaccine that have left patients, trial participants, and those who chose to be vaccinated with the Pfizer duo, with no answers or remedies for the severe adverse reactions they are experiencing. Approving this shot without a thorough investigation into the adverse reactions that have been reported following COVID-19 vaccination will undoubtedly continue to sow the mistrust of this Administration and the Pharmaceutical Industry as a whole.

While some of the population is eager for a vaccine in hopes of buying back normalcy, there is a lack of long term follow up in patients who have received the COVID-19 vaccine or set of shots by Pfizer and all CV-19 manufacturers. Rushing the the EUA and now rushing FDA approval has and only will continue to feed the mistrust the public already has in these failing medical establishments. With respect to the public, their human rights, and their right to informed consent, it is highly irresponsible to grant FDA approval without at least 2 years of follow up with clinical trial patients and without thorough investigations into the severe adverse reactions that have occurred following the Pfizer Vaccines.

The FDA must revoke 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 citizen's 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. This means that the following are invalid reasons to approve a COVID-19 vaccine: ● To ensure vaccines are accessible after the public health emergency has ended. COVID19 vaccines granted an emergency use authorization (EUA) can be lawfully used after the expiry of the SARS-CoV-2 public health emergency declaration. (This is made clear by the many products for Ebola and Zika viruses which still have active EUAs.1) ● To ensure adequate access to vaccines across the population. A BLA is not necessary to assure access to COVID-19 vaccines. Unlike normal licensing, in which widespread use of a drug or vaccine follows approval, EUAs for COVID-19 vaccines have enabled, and continue to enable, their widespread use. Ensuring access to vaccines is irrelevant to the considerations for issuance of a BLA because broad access to COVID-19 vaccines has already been accomplished. ● To enable vaccine mandates. Consideration of vaccine mandates is outside of FDA’s purview. Furthermore, a mandate should only be considered once the evidentiary conditions are met for a BLA (demonstrating that benefits outweigh harms). ● To bolster public confidence. Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA’s purview. Approving before substantial evidence that population-based evidence of clinical effectiveness is superior to harms may contribute to public wariness and hesitancy, not only about COVID-19 vaccines, but other vaccines and public health authorities more broadly. An approval may bolster public confidence, but it is not a valid reason to approve. Regardless of any legitimacy of each of the above reasons, none provides grounds to approve a COVID-19 vaccine. The widespread use of a COVID-19 vaccine under EUA, particularly for a limited amount of time, also is not a valid reason to approve a product. Even if vaccine recipients are followed up within observational studies, such studies may have important design biases and flaws, and their conclusions, especially concerning clinical effectiveness outcomes, may not be reliable. Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of US residents, with global ramifications considering the international importance of FDA decisions. It also could set a precedent of lowered standards for future vaccine approvals."

The mishandling of 2020's pandemic of Covid-19 has created a large wave of additional vaccine hesitant individuals. The FDA approved an EUA which sowed even more distrust and now, the FDA plans to approve the Pfizer Vaccine without a public meeting. This is further proof that the interest of the public is not truly the concern of this administration and the lack of integrity wreaks of a conflict of interest, or many. FDA approval means strengthened mandates and strengthened mandates only equate to more money. The public is aware of this now more than ever and vaccine hesitancy continues to rise. I condemn the use of an emergency and pandemic to seize the opportunity and take advantage of the public's trust and desperation to get back to normal. The FDA MUST revoke its approval if it truly cares to salvage the relationship of the public's trust.

The following are invalid reasons to approve a COVID-19 vaccine: ● To ensure vaccines are accessible after the public health emergency has ended. COVID19 vaccines granted an emergency use authorization (EUA) can be lawfully used after the expiry of the SARS-CoV-2 public health emergency declaration. (This is made clear by the many products for Ebola and Zika viruses which still have active EUAs.1 ) ● To ensure adequate access to vaccines across the population. A BLA is not necessary to assure access to COVID-19 vaccines. Unlike normal licensing, in which widespread use of a drug or vaccine follows approval, EUAs for COVID-19 vaccines have enabled, and continue to enable, their widespread use. Ensuring access to vaccines is irrelevant to the considerations for issuance of a BLA because broad access to COVID-19 vaccines has already been accomplished. ● To enable vaccine mandates. Consideration of vaccine mandates is outside of FDA’s purview. Furthermore, a mandate should only be considered once the evidentiary conditions are met for a BLA (demonstrating that benefits outweigh harms). ● To bolster public confidence. Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA’s purview. Approving before substantial evidence that population-based evidence of clinical effectiveness is superior to harms may contribute to public wariness and hesitancy, not only about COVID-19 vaccines, but other vaccines and public health authorities more broadly. An approval may bolster public confidence, but it is not a valid reason to approve. Regardless of any legitimacy of each of the above reasons, none provides grounds to approve a COVID-19 vaccine.