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.