The fine print in the FDA’s authorization documents for the Pfizer-BioNTech Covid-19 vaccine, now being marketed as “Comirnaty,” reveals a timeline of vaccine study benchmarks extending to 2027.
On Tuesday, the Food & Drug Administration gave what has been touted as a full authorization of the Covid vaccine, although there are still population cohorts that remain under clinical study, such as pregnant women and children under age 16.
“On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the Act,” the FDA stated in a letter to the Global Senior Director of Pfizer Ms. Elaine Harkins. “FDA reissued the letter of authorization on: December 23, 2020, February 25, 2021, May 10, 2021, June 25, 2021, and August 12, 2021.”
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
There are continuing benchmarks that will almost certainly be accompanied by fresh demands to get more Americans vaccinated for Covid-19 and its emerging “variants.”
In a letter to Amit Patel in Pfizer’s regulatory department, the FDA lays out that a series of clinical trials are needed to assess further risks to target populations in order to expand its Covid vaccine coverage. The FDA mentions “known serious risks” to younger populations, particularly those ages 16 and under.
“We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis,” the FDA states, before issuing its proscribed course of future clinical studies and accompanying deadlines.
The deadline for assessing the risks of pericarditis and myocarditis in a ‘Post-Approval Safety Study’: October 31, 2025. This suggests that the ‘full authorization’ for those 16 and up was rushed, given the known risks.
The FDA also requested more research on the long-term effects of myocarditis after vaccination, which suggests there are still unknown risks. The study’s completion is due December 31, 2026. The final report submission is May 31, 2027.
The Covid vaccine’s risks to pregnant mothers will continue to be under study until at least December 31, 2025.
“For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product,” the FDA stipulated. “Label your annual report as an Annual Status Report of Postmarketing Requirements/Commitments and submit it to the FDA each year within 60 calendar days of the anniversary date of this letter until all Requirements and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released.”
Remarkably, in the FDA’s documents, it states outright: “In the U.S., there are no licensed vaccines or anti-viral drugs for the prevention of COVID-19.” The acknowledgment underscores that the “vaccines” are essentially treatments to lower symptom severity, and are therefore a tool for physicians to instrumentalize on a patient-by-patient basis, according to various known health risks.
The prevailing issue is whether or not the viral transmission vectors of animal reservoirs, in other words, wildlife that can host SARS-CoV-2 and produce mutated strains, as well as the vaccines and boosters themselves, hypothetically lead to the development of new variants. These new strains very well could annually relegate Covid vaccines to glorified ‘flu shots,’ whose predominate use is to reduce symptom severity in the elderly, immunocompromised, and the clinically obese.
Mass vaccinations for everyone in the population, regardless of health risk, could therefore not only be a relatively fruitless expenditure of immense effort, but actually sow the seeds for vaccine and drug-resistant strains that pose more of a threat.
The Covid-19 virus ultimately leading to the Covid-27 virus, and beyond, is a series of events that the American people need to countenance now. Whether or not they want to trade the freedom to make their own health choices with their personal doctors for the illusion of security being offered by public health bureaucrats is a consequential decision that now faces them all.