Link to pdf of full document: FDA Petition-2021-P-0521-0001_attachment_1
KEY ELEMENTS OF THE PETITION
“ In this petition, we outline efficacy and safety measures that must be met before serious consideration is given to granting a 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 SARS-CoV-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.
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.” …
“…I. ACTIONS REQUESTED
Petitioners request that the FDA, prior to granting any license for a COVID-19 vaccine:
1. Confirm, in revised Guidance, that the FDA expects a minimum of 2 years of follow-up of participants enrolled in pivotal clinical trials, even if trials are unblinded and lack a placebo control.
2. Require data demonstrating substantial evidence of clinical effectiveness that outweighs harms, in all special populations, as a condition of consideration of including these populations among the indicated populations. Special populations include: infants, children, and adolescents; those with past SARS-CoV-2 infection; immunosuppressed individuals; those with history of or current cancer; individuals with hematological disorders or autoimmune diseases; pregnant or nursing women; and frail older adults.
3. Require data on the safety and pharmacokinetic profiles of the spike protein.
4. Require data from biodistribution studies investigating the actual COVID-19 vaccines.
5. Require data from pharmacovigilance systems in the US and globally documenting a thorough investigation of serious adverse events, carried out by independent, impartial individuals.
6. Clarify in revised Guidance that safety data from individuals receiving more than 2 vaccine doses must be submitted.
7. Ensure the inclusion of experts in gene therapy in the VRBPAC.
8. Ensure that the analysis of data and decisions regarding any COVID-19 vaccine BLA application are informed by experts with no financial or research relationships with any vaccine manufacturers within the last 36 months, both within FDA and amongst the composition of the VRBPAC.”
DETAILED RATIONALE FOR ABOVE PROVIDED IN DOCUMENT, WITH FULL REFERENCES…
