Although Dr. Anthony Fauci has spent the better part of two years assuring the public of the safety of COVID-19 vaccines, he expressly stated the necessity of adhering to an exhaustive three-stage clinical trial approval process in October of 2019 for any future developments in vaccine manufacturing. In another seemingly endless line of historical statements which contradict the various positions Fauci has contemporaneously, video has emerged in which the NIAID Director expressly compromises the fundamental premise of his support of Operation Warp Speed's mass vaccination campaign.
During the Milken Institute Future of Healthcare Summit in 2019, Fauci joined a panel moderated by New Yorker staff writer Michael Specter discussing the future of vaccine development. During the discussion, the topic shifted to the premise of a universal flu vaccine. Specter introduces the idea by stating that a the medical paradigm behind vaccines needs to be completely changed, asking "Why don't we blow the system up? I mean, obviously we can't just turn off the spigot on the system that we have an say 'Oh hey, everyone in the world should get this new vaccine we haven't given to anyone yet' but there must be some way..." Specter, who serves as an adjunct professor of bioengineering at Stanford University took that tenor opining that the current methods of vaccine development through in vitro cell culture in place for over 50 years has become anachronistic.
Fauci's conjecture to Specter's opinion was agreeable, although moderate. He would go respond to the idea by doubling down on the importance of adhering to the "tried and true process" in place which has been entirely disregarded during the development of the mRNA vaccines to fight the SARS-CoV-2 pandemic which a Chinese dissident stated had already begun by the time the October 29th, 2019 discussion had taken place. Fauci asserted:
"In order to make the transition from getting out of the tried and true egg growing which we know gives us results that can be, you know, beneficial, I mean we've done well with that, to something that has to be much better, you have to prove that this works and then you have to go through all of the clinical trials: phase 1, phase 2, phase 3, and then show that this particular product is going to be good over a period of years. That alone, if it works perfectly, is going to take a decade."
Fauci's statements clearly convey the importance of existing oversight in assuring the safety and efficacy of new vaccine technologies. Yet, much of the support for the use of mRNA technology behind the vaccines designed to combat COVID-19 was predicated upon the idea that traditional vaccines using attenuated viruses require an exhaustive, decade-long process which was an unconquerable hurdle given the sense of urgency behind the response to an on-going pandemic.
As of June, 2020, only 10 of over 133 candidates for COVID-19 vaccines had been approved for human trial, per the World Health Organization. Yet, by that time, the first vaccines administered under emergency use authorizations throughout the world had been in use for over 7 months. Despite the lack of adherence to the exhaustive regulatory process in place, Pfizer lauded the preliminary results of its initial studies as being tantamount to those vetted following traditional clinical trials. Michael Yeadon, former chief scientist and Vice President of Pfizer's Allergy and Respiratory Research Unit, and Dr. Wolfgang Wogard filed an emergency petition seeking to halt the process put in place to halt the ad hoc trials that the European Medicines Agency put in place to authorize the emergency use of Pfizer's and other's COVID-19 vaccines in the EU. A copy of the petition was also sent to the U.S. Food and Drug Administration at the time of its filing. The basis of the petition asserted that the trials in place which circumvented those such as the existing three-phase clinical trial process were "inadequate to accurately assess efficacy" of the mRNA vaccines. The basis for this assertion was predicated upon a multitude of issues, including the propensity for high cycle thresholds of RT-PCR tests being a diagnostic crux used in the study.
The petitioners went on to express their concerns for the potential crises which could emerge if the unproven vaccines were authorized for emergency use, including the risk of antibody dependent enhancement observed in conventional clinical trials for other mRNA vaccines, the high risk of allergic reactions to the polythylene glycol used by Pfizer and BioNTech to coat the lipid nanoparticles designed to deliver mRNA, and the impact that the antibodies produced by the response to vaccines could have in attacking the cells necessary for the formation of placenta cells in pregnant women. Yeadon and Wodarg's grounds for the petition convey the complexity of developing a novel vaccine and the important of adherence to existing clinical trial processes, a position tantamount to that which Fauci previously opined during the Milken Institute Future of Healthcare Summit in October of 2019. Yet, despite the extensive concerns that existed which were more relevant than every given the timing of their execution, adherence to existing regulations were entirely abandoned in order to approve these mRNA vaccines.
In hindsight, the discussion held by the panel including Fauci serves as a prescient forecast for the vaccine development under Operation Warp Speed. Rick Bright, the Director of Biomedical Advanced Research & Development Authority at the Department of Health and Human Services sounded close to clairvoyant as her entertained the idea that:
"...it is not too crazy to think that an outbreak of a novel avian virus could occur in China somewhere. We could get the RNA sequence from that, beam it to a number of regional centers, if not local, if not even in your home at some point and print those vaccines on patches and self-administer them."
Though pointing out that Fauci's testimony best serves to reinforce the issues regarding the approval and administration of mRNA vaccines against COVID-19, it also should be used as an example of how issues like this hidden in plane sight can offer valuable insight into the future. Given that research akin to the possibility introduced by Robert Bright is rapidly unfolding, the panel discussion from Milken Institute Future of Healthcare Summit in 2019 should serve not just as basis of conjecture against what has been put in place for us to arrive at where we stand amidst a hurried, disjointed, and dangerous mass vaccination campaign but also as an ominous forewarning of what lays ahead on the path it has already paved.