A controversial figure of late, Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) has been front and center in the regulatory agency’s aggressive greenlights associated with the COVID-19 vaccines during the pandemic. Among other things, the agency has been criticized for dropping its rigorous standards during the COVID-19 Public Health Emergency at least, when applied to the mRNA vaccines targeting SARS-CoV-2. Interestingly, Dr. Marks has now gone on the record in a piece published in JAMA Network titled “Urgent Need for Next Generation COVID-19 Vaccines” in a clear recognition that the current “version 1.0”, first generation COVID-19 vaccines are no longer viable to protect the American public. This media has labeled the COVID-19 vaccines as novel, version 1.0 since the late spring of 2021, when it became very apparent that vaccine durability challenges coupled with a mutating virus (which was called out by critical scientists from the start) represented a challenge for vaccine durability. While TrialSite maintains the COVID-19 vaccines partially blunted the sharp edge of the pandemic, initially they did so at a severe cost. The vaccines were bundled in a program precluding any serious embrace of early care with repurposed drugs, orchestrated government censorship of media and social tech, and harassment of doctors that dared question any moves by Washington DC or industry all representing perhaps, one of the greatest public health failures in modern history. More people died in America from SARS-CoV-2 than any other nation despite the vast trillions, sophisticated technologies and supposed state-of-the-art vaccines. From the start influencers such as the Food and Drug Administration, National Institutes of Health, and Centers for Disease Control and Prevention, not to mention academic medicine, big hospital administration, and industry all bought in hook, line, and sinker into the scheme that mass COVID-19 vaccination would control and eradicate SARS-CoV-2, the virus behind COVID-19. In fact, the World Health Organization (WHO) specifically established the 70% vaccination rate as a target threshold to achieve herd immunity. But from near the start this media, and a minority of independent, critical scientists questioned aloud that logic. Could a dynamic RNA virus that mutates like say, HIV or influenza, be controlled by a novel mass vaccination scheme? Has the flu been controlled out of existence? This seemed a crap shoot at best, yet the U.S. federal government and its health agencies along with other of the world’s richest most sophisticated economies bet the proverbial farm on novel technology in a way that was guaranteed to not work as intended. Was this a totally desperate move or part of some orchestrated response to advance a biomedical platform? While the vaccines worked to induce antibodies for short bursts, they did save lives, especially earlier on. But within months (Delta appeared by spring of 2021) of the mass vaccination program it was apparent that they failed to control the spread of the pathogen, exhibited poor durability, and were associated with a disturbing safety signal in the Vaccine Adverse Event Reporting System. While by the summer of 2021 the whole program should have been under investigation President Biden ordered mandates across the board by September 2021. Now two years later since they were first released on the market Peter Marks initiates a dialogue paving the way to sunset these products, thinking ahead for a next generation of more effective, safety COVID-19 vaccine. But that’s not enough.
Now on the record, that while issues of “vaccines access and hesitancy present throughout the pandemic are partially responsible,” the relentless, or in his words “ceaseless progression of increasingly transmissible variants, recently including BF.7 and BQ.1.1 presents a major challenge to medical interventions, particularly vaccines.”
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